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Pfizer - BioNTech - Shanghai Fosun Pharmaceutical Group, vaccine BNT162

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Post by Abacus Mon Dec 28, 2020 10:45 pm

(April 21, 2017) Health companies gave generously to President Trump’s inauguration
Facing acute risks to their businesses from Washington, D.C., policymakers, health companies spent more than $2 million to buy access to the incoming Trump administration
via candlelight dinners, black-tie balls and other U.S. presidential inauguration events, new filings show.
Drugmaker Pfizer gave $1 million to help finance the inauguration, according to documents filed with the U.S. Federal Election Commission.
Amgen, another pharmaceutical company, donated $500,000. Health insurers Anthem, Centene and Aetna all gave six-figure contributions.
Also writing checks for the inauguration were drugmaker Abbott Laboratories,
drug wholesaler Caremark, insurer MetLife and Managed Care of North America,
a dental benefits manager.

(August 16, 2018) Pfizer pays BioNTech $120M upfront to form mRNA flu vaccine pact
Pfizer has struck a $425 million deal to work with BioNTech on the development of mRNA influenza vaccines.
The Big Pharma is providing $120 million in upfront and near-term payments to enter into the R&D collaboration.
Germany’s BioNTech has established itself at the forefront of the mRNA field, leading to deals with Eli Lilly, Genentech and Sanofi
and a $270 million series A. Many of the collaborations, plus BioNTech’s internal programs, are using mRNA to activate the immune system
against tumors. But the approach could also yield prophylactic vaccines that are more potent and easier to make than existing shots.
BioNTech and Pfizer will collaboratively take the mRNA vaccines through the early R&D steps.
Once a first-in-human study is complete, Pfizer will take sole responsibility for advancing the vaccines through the rest of clinical development.

(November 5, 2018) BioNTech and the University of Pennsylvania Enter into Strategic Research Collaboration to Develop mRNA Vaccine Candidates Against Various Infectious Diseases
BioNTech AG, a rapidly growing biotechnology company focused on the development of immunotherapies for the precise and individualized treatment of cancer and prevention of infectious diseases
and the University of Pennsylvania (Penn), Philadelphia, USA, today announced that they have entered into a strategic research collaboration.
The goal of the exclusive, multi-year partnership is to develop novel nucleoside-modified mRNA vaccine candidates for the prevention and treatment of various infectious diseases.
BioNTech will be eligible to receive an exclusive worldwide license to further develop and commercialize product candidates arising from the research collaboration.
If proprietary Penn technology is part of a new mRNA-based vaccine, the university will be eligible to receive additional milestone payments and royalties from BioNTech.
Detailed financial terms were not disclosed.

(December 10, 2018) Global coalition backs Imperial College London’s RNA vaccine platform to fight ‘Disease X’
In a new deal, the outbreak-focused group CEPI is putting down $8.4 million for Imperial College London to work on a self-amplifying RNA (saRNA) vaccine platform
that can be used to rapidly develop vaccines against pathogens—even unknown ones.
And the British institution will partner with BioNTech
in the manufacturing of such vaccines to assess their potential.
Imperial will first develop the platform, called RapidVac,
to produce vaccines against H1N1, rabies, and Marburg as proof of concept for the project,
a CEPI spokesman told FiercePharma. Once the platform is validated, CEPI hopes
it can be used to develop vaccines rapidly against new and unknown pathogens, known as “Disease X.”

(January 23, 2019) BioNTech Buys MAB Discovery’s Antibody Generation Unit
BioNTech AG, located in Mainz, Germany, inked a deal with Munich, Germany’s MAB Discovery GmbH
to acquire MAB’s operational antibody generation unit.
No financial details were disclosed. BioNTech will acquire all assets,
employees and “proprietary know-how” for monoclonal antibody (mAb) generation.
The two companies have been collaborating for more than five years,
where MAB generated antibodies using its technology, which is then further developed by BioNTech.
BioNTech is the largest, privately-held biopharma company in Europe.
Its majority shareholders include the Struengmann Family Office,
Fidelity Management & Research Company, Invus, Janus Henderson Investors,
MIG Fonds, Redmile Group, Salvia and several European family offices.

(July 24, 2019) Warren Seeks Answers from Pharmaceutical Giant Pfizer on Appointment of Former FDA Commissioner Gottlieb to Board of Directors
United States Senator Elizabeth Warren (D-Mass.) today sent a letter to pharmaceutical company Pfizer
to request information regarding the decision to name Dr. Scott Gottlieb,
former Commissioner of the U.S. Food and Drug Administration (FDA), to the company’s Board of Directors.
The letter follows a call by Senator Warren earlier this month for Dr. Gottlieb to resign from his position at Pfizer.
Dr. Gottlieb is the second high-level Trump Administration official in less than two months who,
soon after leaving government service, joined the board of a corporation with interests related to their work in the administration.
In May, former Department of Homeland Security Secretary and Chief of Staff John Kelly,
who helped lead the Trump administration's "zero-tolerance" immigration policy
that led to forcibly separating thousands of migrant children from their parents,
joined the board of Caliburn, Inc., the parent company of the Comprehensive Health Services,
which runs the Homestead Temporary Shelter for Unaccompanied Children in Florida.



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Post by Abacus Mon Dec 28, 2020 10:47 pm

(March 16, 2020) BioNTech and Fosun Pharma form COVID-19 vaccine strategic alliance in China
MAINZ, Germany, and SHANGHAI, China, March 16, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech”)
and Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Symbol: 600196.SH, 02196.HK)
announced today a strategic development and commercialization collaboration to advance BioNTech’s mRNA vaccine candidate BNT162 in China
for the prevention of COVID-19 infections. Under the terms of the agreement, the two companies will work jointly on the development
of BNT162 in China. The companies will collaborate to conduct clinical trials in China leveraging Fosun Pharma’s extensive clinical development,
regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialize the vaccine in China.
BioNTech will supply the mRNA vaccine for clinical trials from GMP manufacturing facilities in Europe along with its partner Polymun.
BioNTech will retain full rights to develop and commercialize the vaccine in the rest of the world.

(July 1, 2020) Pfizer, BioNTech coronavirus vaccine candidate gins up antibodies in early trial
Pfizer and its partner BioNTech posted early positive data from one of their four candidates.
With this first win—and other data yet to come—the partners are prepping for a late-stage test
that could begin as early as this month.
In a phase 1/2 trial, all participants who received 10 micrograms (mcg) or 30 mcg of the mRNA vaccine candidate
generated antibodies that were 1.8 times and 2.8 times higher, respectively, than the average of a group of patients who had confirmed prior infections.
Plus, the shot wasn't without side effects. Fevers of at least 100 degrees cropped up in three-fourths of the 12 people who received the mid-range dose of the shot.
Just 8% of those who received the lowest dose developed fevers, though, and the partners said side effects were overall brief and not severe.

(Jul 13, 2020) Pfizer, BioNTech nab fast track tag, prep for major phase 3 COVID-19 vax test this month
Pfizer and German mRNA partner BioNTech have grabbed an FDA fast track label as they look to start a late-stage, 30,000-patient COVID-19 vaccine test
before the month is out. The phase 2b/3 trial could start “as soon as later this month,”
the partners said in a statement this morning, and they are “anticipating enrolling up to 30,000 subjects.”
Should it past muster, the partners are looking to manufacture up to 100 million doses by the end of 2020
and “potentially more than 1.2 billion doses by the end of 2021.”
The trial programs are made up for experimental vaccines under the BNT162 project.
It’s also grabbed, perhaps inevitably, an FDA fast track for two of the four vaccines, namely the two most advanced: BNT162b1 and BNT162b2.
The fast track comes after some initial U.S. results out earlier this month from an early clinical test of 45 patients
that showed all of them who received 10 micrograms or 30 mcg of the mRNA vaccine candidate generated antibodies that were 1.8 times and 2.8 times higher,
respectively, than the average of a group of patients who had confirmed prior infections, although it did come with side effects.

(July 20, 2020) U.K. Orders 90 Million Covid-19 Vaccine Doses from Pfizer, Valneva
The U.K. has signed agreements to buy 90 million doses of vaccines in development by drugmakers including Pfizer Inc., BioNTech SE and Valneva SE,
joining countries around the world racing to secure supplies of protection against Covid-19.
Pfizer and BioNTech plan to supply 30 million doses of their vaccine candidate this year and next,
the companies said. France’s Valneva agreed to supply the U.K. with 60 million doses of the shot it’s developing,
and another 40 million if the product proves safe and effective.
Britain has already struck a supply agreement for a vaccine being tested by AstraZeneca Plc with the University of Oxford.
Astra shares rose as much as 5.8% to a record in London ahead of news from a clinical trial due later on Monday.
The U.K., a nation of 66 million people, described the order for the vaccine being developed by Pfizer and BioNTech as that alliance’s
first binding agreement with any government. The U.S. has been supporting the companies’ efforts through its $10 billion Operation Warp Speed research program.

(July 22, 2020) Pfizer Signs Nearly $2B Contract With US for Virus Vaccine
WASHINGTON (CN) — As the number of confirmed U.S. cases of Covid-19 neared 4 million
on Wednesday, the Trump administration announced an almost $2 billion vaccine contract
with the New York-based pharmaceutical giant Pfizer and a German biotechnology company.
According to a statement released by the U.S. Department of Health and Human Services(HHS), the Department of Defense(DoD) will pay Pfizer and BioNTech $1.95 billion
upon the receipt of the first 100 million doses, which would need to be approved by the Food and Drug Administration before distribution.
Lee Riley, a professor of epidemiology at the University of California, Berkeley, says that another major advantage of nucleic-acid-based vaccines
is that they can induce both antibody and cell-mediated immune responses, a combination that may lead to protections against different strains of a virus.
“A lot of work has been done on DNA vaccines, especially for veterinary work,
and some such vaccines have been approved,”
he said, citing the example of a vaccine used to protect horses from West Nile disease.

(August 2, 2020) Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan
New York-based Pfizer and Mainz, Germany-based BioNTech said Friday that they would provide 120 million doses
of vaccine from their BNT162 development program, assuming regulatory approval, to Japan’s Ministry of Health, L
abor and Welfare, in the first half of 2021. Financial details were not disclosed,
and terms were based on timing of delivery and volume of doses,
but the companies had signed a deal with the U.S. government
to supply 100 million doses of vaccine for $1.95 billion.

(August 3, 2020) Pfizer says Covid-19 vaccine may be needed regularly
Pfizer expects that a Covid-19 vaccine could be needed regularly to effectively protect from the virus.
Pfizer CEO Albert Bourla was quoted as saying: “There is a likely scenario that either the vaccine’s immunity will not be lasting forever,
or that the virus will mutate, or that the virus will find ways to come back again and again.”
During its earnings call on 28 July, the company proposed a two-phase commercial strategy
for its vaccine, which is being developed in alliance with German company BioNTech and is currently undergoing clinical trials.
The first pandemic phase is expected to last through 2020 or into 2021,
and will see dose production in high volumes for mass vaccinations, with pricing for broad access.
This broad access pricing is a $1.95bn agreement signed by the US Government last week to buy 100 million doses
of the Pfizer-BioNTech vaccine, if it receives regulatory approval.
During the second seasonal phase, Pfizer sees the need for regular annual or bi-annual immunisations.
This phase is set to involve a value-based pricing approach.

(August 5, 2020) Canada inks deals with Pfizer, Moderna for coronavirus vaccine candidates
The Canadian government has signed new deals with pharmaceutical firms Pfizer and Moderna to secure millions of doses in 2021
of the coronavirus vaccine candidates each company is currently developing.
Pfizer is currently working on four experimental coronavirus vaccines
and Moderna is also working on what’s been described as among the leading candidates for a vaccine.
Anand said the agreements will be for “millions of doses” but didn’t specify an exact amount,
adding that the goal is to make sure “Canadians are at the front of the line when a vaccine becomes available.”

(August 7, 2020) Pfizer Announces Agreement with Gilead to Manufacture Remdesivir for Treatment of COVID-19
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced a multi-year agreement with Gilead Sciences, Inc.
to manufacture and supply Gilead’s investigational antiviral remdesivir,
as one of multiple external manufacturing organizations supporting efforts to scale up supply
of the investigational treatment for COVID-19. Under the terms of the agreement,
Pfizer will provide contract manufacturing services at Pfizer’s McPherson, Kansas facility
to manufacture and supply remdesivir for Gilead.

(September 1, 2020) BioNTech, Fosun Pharma to supply 10 million doses of BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to Hong Kong SAR & Macao SAR
BioNTech SE and Shanghai Fosun Pharmaceutical (Group) Co., Ltd (Fosun Pharma) announced an intended collaboration to supply 10 million doses of their BNT162 mRNA-based vaccine
candidate against SARS-CoV-2, subject to clinical success and regulatory approval, to Hong Kong (Special Administrative Region of China, SAR) and Macao (SAR).
Fosun Industrial Co., Limited, a wholly owned subsidiary of Fosun Pharma has entered into the Letter of Intent with Jacobson Pharma Corporation Limited
in relation to the contemplated distribution of 10 million doses of vaccine targeting at COVID-19 in the Region on 27 August.
BioNTech and Fosun Pharma announced their strategic collaboration on March 13, 2020.
The two companies are working jointly on the development and commercialization of potential COVID-19 vaccine products
based on BioNTech’s mRNA technology platform in Mainland China, Hong Kong and Macau Special Administration Region and the Taiwan Region.

(September 9, 2020) Pfizer, BioNTech in EU Vaccine Deal That’s Their Biggest Yet
Pfizer Inc. and BioNTech SE reached a preliminary agreement to supply 200 million doses
of their experimental Covid-19 vaccine to the European Union
-- the biggest initial order yet for the U.S.-German partners.
The European Commission has concluded exploratory talks and will now begin contract negotiations,
according to a statement Wednesday. The deal would include an option for another 100 million doses.

(September 15, 2020) BioNTech Gets $445 Million in German Funding for Vaccine
(Bloomberg) -- BioNTech SE will get as much as 375 million euros ($445 million) from Germany to back its Covid-19 vaccine program,
about half of the money the government set aside to accelerate development of immunizations.
The German biotech company is working with Pfizer Inc. and Shanghai Fosun Pharmaceutical Group Co.
on what is expected to be one of the first vaccines to deliver results from late-stage human trials.
Pfizer has repeatedly said data from a U.S. study could be ready next month.
Germany is splitting its funding between BioNTech and rival vaccine developers CureVac NV and IDT Biologika GmbH.
CureVac will get 230 million euros, while talks are still going on with IDT Biologika, Research Minister Anja Karliczek said in a press conference in Berlin.

(September 17, 2020) BioNTech buys German site from Novartis to boost vaccine output
Germany’s BioNTech is purchasing a German biotech production site from Swiss drugs giant Novartis to boost output
of the coronavirus vaccine hopeful it is developing with Pfizer. The facility in the German city of Marburg
will be converted to be fully on stream in the first half of 2021 with an annual production capacity up to 750 million doses
of the inoculation, based on the so-called messenger RNA (mRNA) technology.
The two companies were previously aiming to supply up to 100 million doses
worldwide by the end of this year and an additional 1.3 billion doses by the end of 2021.
The new site, with its 300 staff that will join BioNTech, will allow for a larger 2021 output target
but it is not yet clear by how much on balance, a company spokeswoman said.

(October 12, 2020) Pfizer and BioNTech enter Covid-19 vaccine deal with New Zealand
Pfizer and BioNTech have entered an agreement with the New Zealand Government to supply 1.5 million doses of their potential Covid-19 vaccine.
Expected to take place by the first quarter of next year, the delivery could vaccinate approximately 750,000 people in New Zealand.
The parties did not divulge the financial terms of the agreement, which marks the government’s first vaccine purchase.
According to officials, discussions are ongoing with other pharmaceutical firms
to buy more vaccine doses for the country of five million people.
Further announcements on vaccine supply deals should take place next month.

(October 26, 2020) Coronavirus document disclosure motion could ‘jeopardize’ vaccine for Canadians
Procurement Minister Anita Anand says if opposition parties approve a parliamentary probe
of the government’s handling of the coronavirus pandemic — including some of its sensitive contracts —
then suppliers for coronavirus vaccine candidates and protective gear could “walk away.”
“I do not want to be back here to explain to Canadians that because of the disclosure we were forced to make,
we were not able to secure vaccines or PPE for Canadians because our supplies chose to walk away,”
she said during a press conference on Monday morning.
“I am seriously saying our contracts – vaccines, PPE, rapid test kits – are in jeopardy.”
Pharmaceutical giant Pfizer Canada is among those raising concerns about the motion, set to be voted on in the House of Commons Monday.

(November 11, 2020) Pfizer, BioNTech to Supply 200M Doses of BNT162b2 to EU
Pfizer and BioNTech SE have reached an agreement with the European Commission to supply 200 million doses
of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to EU Member States,
with an option to request an additional 100 million doses.
Deliveries are anticipated to start by the end of 2020,
subject to clinical success and regulatory authorization.
The vaccine doses will be produced at BioNTech’s German manufacturing sites,
as well as Pfizer’s manufacturing site in Belgium.
The BNT162 program is based on BioNTech’s mRNA technology
and supported by Pfizer’s global vaccine development and manufacturing capabilities.
Two of the companies’ four investigational vaccine candidates – BNT162b1 and BNT162b2 –
received Fast Track designation from the U.S. FDA, with Phase 1/2 studies currently ongoing in the U.S. and Germany.

(December 2, 2020) UK MHRA grants emergency use authorization to Pfizer & BioNTech’s mRNA vaccine, BNT162b2 against COVID-19
Pfizer and BioNTech announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization
for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19.
“The Emergency Use Authorization in the UK will mark the first time citizens outside
of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin,
M.D., CEO and co-founder of BioNTech. “We believe that the roll-out of the vaccination program
in the UK will reduce the number of people in the high-risk population being hospitalized.
Our aim is to bring a safe and effective vaccine upon approval to the people who need it.

(December 3, 2020) Coronavirus vaccine: Pfizer given protection from legal action by UK government
The UK government has granted pharmaceutical giant Pfizer a legal indemnity protecting it from being sued,
enabling its coronavirus vaccine to be rolled out across the country as early as next week.
The Department of Health and Social Care has confirmed the company has been given an indemnity
protecting it from legal action as a result of any problems with the vaccine.
Ministers have also changed the law in recent weeks to give new protections to companies such as Pfizer,
giving them immunity from being sued by patients in the event of any complications.

(December 4, 2020) Pfizer COVID jab warning: No breastfeeding, avoid pregnancy for 2 months, unknown fertility impacts
UK Government produced safety instructions for a new coronavirus vaccine indicate that it should not be used by pregnant or breast-feeding mothers and children.
In addition, they state that it is unknown what effect the COVID-19 mRNA vaccine will have on fertility.
In a section called “Fertility, pregnancy and lactation,” the guide says there is “no or limited data” on the vaccine.
Therefore, it is not recommending its use for pregnant women.
“Animal reproductive toxicity studies have not been completed.
COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy,” the guide states in section 4.6.
But alarmingly the guide has only one thing to say about the vaccine’s impact on fertility: they don’t know if it does or doesn’t.

(December 9, 2020) Health Canada Green Lights COVID-19 Vax
Pfizer Canada and BioNTech SE said that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2).
The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the National Advisory Committee on Immunizations (NACI).
BioNTech will hold the regulatory approval in Canada, while Pfizer Canada will have the commercialization rights.
Pfizer will have the marketing and distribution rights worldwide with the exception of China, Germany and Turkey.

(December 9, 2020) PostEra, Pfizer ink pact to advance machine learning for drug discovery
PostEra, a biotechnology company, announced a strategic partnership with Pfizer
with the goal of accelerating small molecule drug discovery
by developing a platform technology based on generative chemistry.
PostEra's machine learning technology is intended to accelerate the drug discovery process
by designing novel molecular structures with optimised potency and drug-like properties.
PostEra will receive an upfront payment and is eligible to receive additional payments as the project progresses.
PostEra will also retain ownership rights to all algorithms developed during the collaboration.

(December 11, 2020) White House threatens to fire FDA chief unless Pfizer Covid vaccine approved Friday, report says
White House chief of staff Mark Meadows told the head of the Food and Drug Administration to submit his resignation
if the agency doesn’t clear Pfizer’s coronavirus vaccine for emergency use by day’s end, The Washington Post reported Friday.
The warning led FDA Commissioner Stephen Hahn and the agency to accelerate its timetable for clearing America’s first Covid-19 vaccine
from Saturday morning to later Friday, according to the Post, which cited anonymous sources.

(December 14, 2020) Singapore approves Pfizer-BioNTech COVID-19 vaccine
The Health Sciences Authority (HSA) has granted an authorization 14 Dec 2020 under the Pandemic Special Access Route (PSAR)
for the Pfizer-BioNTech COVID-19 vaccine to be used in Singapore for the prevention of COVID-19. The vaccination regime
submitted by Pfizer-BioNTech requires two doses of vaccine to be administered 21 days apart, in individuals aged 16 years and above.

(December 18, 2020) BioNTech, Shanghai Fosun Pharma to Supply COVID-19 Vax to China
BioNTech SE and Shanghai Fosun Pharmaceutical (Group) Co. Ltd. have signed an agreement to supply Mainland China
with an initial 100 million doses of their BNT162 mRNA-based vaccine candidate against COVID-19 in 2021,
subject to regulatory approval. Initial supply will be delivered from BioNTech’s production facilities in Germany.
In March 2020, BioNTech and Fosun Pharma announced their strategic collaboration to work jointly
on the development and commercialization of a potential COVID-19 vaccine based on BioNTech’s mRNA technology platform.

(December 19, 2020) Switzerland Approves Pfizer Shot as First Covid-19 Vaccine
Switzerland has authorized Pfizer Inc.’s and BioNTech SE’s Covid-19 vaccine, the first approved for use in the country.
Switzerland had previously signed contracts with the companies for the delivery of three million vaccine doses.
The first delivery of about 100,000 doses will arrive this year, with larger batches to follow,
according to a separate statement from the Federal Office of Public Health.
The Swiss nod comes after the U.K. and U.S. among others have already approved the vaccine,
while European Union regulators will be meeting next week to decide.
The public health office said that the vaccines from Moderna and AstraZeneca
are still undergoing Swissmedic’s approval process and the latter is “unlikely” to be available until the middle of next year.

(December 21, 2020) EU approves BioNTech-Pfizer COVID vaccine
The European Medicines Agency (EMA) and the European Commission approved the BioNTech-Pfizer coronavirus vaccine on Monday.
The EMA's positive assessment of the vaccine was widely expected.
The Amsterdam-based drug regulator was under pressure from European countries,
including Germany, to speed up its decision, which was originally scheduled for December 29.
"We granted conditional market authorization to the vaccine produced by BioNTech and Pfizer,"
European Commission President Ursula von der Leyen said in a statement, just hours after the EMA recommendation to approve the vaccine.

(December 23, 2020) U.S. buys another 100M doses of Pfizer-BioNTech coronavirus vaccine
Pfizer and its German partner BioNTech will supply 100 million more doses of their coronavirus vaccine to the United States by this summer
after protracted negotiations over how much the companies could deliver, given their commitments to other nations.
The $1.95 billion agreement doubles the overall U.S. order for the vaccine to 200 million doses.
In addition to the 200 million doses of Pfizer's vaccine, the United States has also ordered 200 million doses of a vaccine from Moderna.
Because each of the vaccines must be given as two shots, those orders are enough to treat 200 million people.





















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Post by Abacus Wed Dec 30, 2020 4:16 pm

(December 28, 2020) Introducing COMIRNATY®, the EU Brand Name for Pfizer & BioNTech's COVID-19 Vaccine, Developed by Brand Institute
Brand Institute, the global leader in pharmaceutical and healthcare related name development,
is proud to announce its role in naming Pfizer and BioNTech's COVID-19 vaccine: COMIRNATY® (koe mir' na tee).
The name was first announced by Swiss regulatory authority, Swissmedic.
Shortly after, it was included in the conditional marketing authorization published by the European Medicines Agency (EMA).
“The name is coined from Covid-19 immunity, and then embeds the mRNA in the middle, which is the platform technology,
and as a whole the name is meant to evoke the word community,” Scott Piergrossi, Brand Institute president of operations and communications, said.

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Post by Abacus Fri Jan 01, 2021 10:48 pm

(December 31, 2020) WHO grants emergency use approval for Pfizer Covid-19 vaccine
The World Health Organization on Thursday granted emergency validation to the Pfizer-BioNTech vaccine,
paving the way for countries worldwide to quickly approve its import and distribution.
The decision "makes the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO
since the (novel coronavirus) outbreak began a year ago," WHO said in a statement.
Britain launched its inoculation drive with the US-German vaccine on December 8, with the United States, Canada and EU countries following suit.

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Post by Abacus Sun Jan 17, 2021 6:14 pm

(January 16, 2021) Norway Raises Concern Over Vaccine Jabs for the Elderly
Norway expressed increasing concern about the safety of the Pfizer Inc. vaccine
on elderly people with serious underlying health conditions after raising an estimate
of the number who died after receiving inoculations to 29.
The latest figure adds six to the number of known fatalities in Norway,
and lowers the age group thought to be affected to 75 from 80. While it’s unclear exactly when the deaths occurred,
Norway has given at least one dose to about 42,000 people and focused on those considered most at risk
if they contract the virus, including the elderly.
bloomberg.com/news/articles/2021-01-16/norway-vaccine-fatalities-among-people-75-and-older-rise-to-29

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Post by Abacus Mon Jan 25, 2021 7:10 pm

(January 22, 2021) Pfizer, BioNTech Enter Vax Pact with COVAX
Pfizer and BioNTech entered an advance purchase agreement with COVAX for up to 40 million doses
of the Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered throughout 2021.
Financial terms were not disclosed.
COVAX is a global initiative coordinated by the Global Alliance for Vaccines and Immunization (GAVI),
the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO),
to ensure equitable access to COVID-19 vaccines for all countries.
The first doses are expected to be delivered in the first quarter of 2021,
subject to the negotiation and execution of supply agreements under the COVAX Facility structure.
contractpharma.com/content-microsite/covid-19/2021-01-22/pfizer-biontech-enter-vax-pact-with-covax?widget=listSection

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Post by hillbilly Mon Jan 25, 2021 10:31 pm

https://www.gavi.org/sites/default/files/covid/pr/COVAX_CA_COIP_List_COVAX_PR_15-12.pdf
Lists of 190 countries involved, don't see muh Russia in there.
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Post by Abacus Tue Jan 26, 2021 9:06 pm

(January 25, 2021) Australia provisionally approves Pfizer COVID-19 vaccine
The Therapeutic Goods Administration (TGA) has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia.
The TGA provisional approval is for individuals 16 years of age and older. Two doses will be required – at least 21 days apart.
A priority group of Australians are expected to now receive their first dose of the vaccine as soon as it can be received from Pfizer
and the necessary checks are undertaken by the TGA, prior to its distribution.
The latest advice given to the Government from Pfizer is that shipping and the first vaccinations are expected to be in late February.
biospectrumasia.com/news/37/17489/australia-provisionally-approves-pfizer-covid-19-vaccine.html

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Post by Abacus Thu Jan 28, 2021 8:03 pm

(January 27, 2021) COMIRNATY becomes first COVID-19 vaccine to receive EUA in Hong Kong
BioNTech SE and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. have announced that according to the Food and Health Bureau of the Hong Kong Special Administrative Region
of the PRC, the COVID-19 vaccine COMIRNATY® (also known as BNT162b2) based on BioNTech's proprietary mRNA technology
has received emergency use authorisation (EUA) in Hong Kong. The vaccine will be produced in BioNTech's manufacturing facilities in Germany,
and supplied to Hong Kong for administration under the Hong Kong SAR Government's COVID-19 Vaccination Program.
biospectrumasia.com/news/37/17495/comirnaty-becomes-first-covid-19-vaccine-to-receive-eua-in-hong-kong.html


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Post by Abacus Fri Jan 29, 2021 10:19 pm

(January 27, 2021) French firm Sanofi to help produce 100 million doses of Pfizer Covid-19 vaccine
The French company will aim to help supply more than 100 million doses of the vaccine this year
from its German plant in Frankfurt, CEO Paul Hudson told Le Figaro newspaper on Tuesday.
Last month, Sanofi and Britain's GlaxoSmithKline said a COVID-19 vaccine they are jointly developing
had shown an insufficient immune response in older people, delaying its launch to late this year.
Sanofi is also working on another COVID-19 vaccine candidate with U.S. firm Translate Bio
which uses mRNA technology, similar to the approach of Pfizer/BioNTech.
france24.com/en/france/20210127-french-firm-sanofi-to-help-produce-100-million-doses-of-pfizer-covid-19-vaccine

(January 29, 2021) Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine
Novartis has signed an initial agreement to leverage its manufacturing capacity and capabilities
in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 vaccine.
The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.
Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech
and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world.
Subject to reaching a final agreement, Novartis plans to commence production in the second quarter of 2021
at its state-of-the art aseptic manufacturing plant in Stein. Initial shipment of finished product is expected in the third quarter.
contractpharma.com/content-microsite/covid-19/2021-01-29/novartis-inks-contract-manufacturing-deal-for-pfizer-biontech-covid-19-vaccine


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Post by Abacus Fri Feb 05, 2021 11:06 pm

(February 3, 2021) New Zealand provisionally approves use of Pfizer coronavirus vaccine
New Zealand's medicine regulator Medsafe has provisionally approved the use of the Pfizer COVID-19 vaccine.
The vaccines are expected to arrive in New Zealand by the end of March,
the Government said, adding that people at highest risk would be vaccinated
before the broader community from the second half of the year.
With vaccination drives underway in dozens of countries — and Australia's approval of the Pfizer vaccine in January
pressure has been mounting on Ms Ardern to start inoculations.
abc.net.au/news/2021-02-03/new-zealand-provisionally-approves-pfizer-coronavirus-vaccine/13117492

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Post by Abacus Fri Feb 05, 2021 11:07 pm

(February 5, 2021) India: Pfizer withdraws COVID vaccine application for emergency use
Pfizer Inc. said on Friday that it has pulled out an application for emergency use authorization of the BioNTech-Pfizer coronavirus vaccine in India.
The decision came after Pfizer representatives met with India’s health regulator on Wednesday,
who refused to grant the pharmaceutical's vaccine the authorization, citing a lack of immunogenicity trials.
The company said that it would shortly submit another authorization request with further information when available.
India's drug regulator wanted Pfizer to conduct local trials to ensure the safety of the vaccine for official authorization.
But the company failed to present evidence that its vaccine was safe for the Indian population,
according to a Central Drugs Standard Control Organization (CDSCO) statement.
dw.com/en/india-pfizer-withdraws-covid-vaccine-application-for-emergency-use/a-56462616

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Post by Abacus Sat Feb 06, 2021 3:26 pm

(February 5, 2021) Australia secures total of 20 million Pfizer-BioNTech vaccines
The Australian Government has secured an additional 10 million doses of the Pfizer-BioNTech COVID 19 vaccine
on the advice of the Scientific Industry Technical Advisory Group on Vaccines.
Through the Government’s Advance Purchase Agreement with Pfizer, this additional 10 million vaccines
means Australia will now receive 20 million Pfizer doses in 2021.
biospectrumasia.com/news/37/17557/australia-secures-total-of-20-million-pfizer-biontech-vaccines.html

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Post by Abacus Sun Feb 28, 2021 11:15 am

(February 8, 2021) EU orders 300 million more BioNTech-Pfizer vaccine doses
The European Commission has wrapped up a deal to receive another 300 million doses of the BioNTech-Pfizer coronavirus vaccine,
a spokesperson told several news agencies Monday. The EU reached a deal with Pfizer in November for 300 million doses
and in January negotiated a preliminary deal for another 300 million.
An EU official told Reuters that the bloc would receive 200 million doses of the vaccine in 2021.
The timeline for the other 100 million was still unclear.
dw.com/en/eu-orders-300-million-more-biontech-pfizer-vaccine-doses/a-56502706

(February 12, 2021) Evonik Strengthens Partnership with BioNTech on COVID-19 Vaccine
Evonik is investing in the short-term expansion of its specialty lipids production
which are essential for mRNA-based COVID-19 vaccines.
Commercial lipid quantities are to be produced at Evonik’s Hanau and Dossenheim sites in Germany
as early as the second half of 2021 as part of a strategic partnership with vaccine manufacturer BioNTech.
This step contributes to increasing the supply security of the Pfizer-BioNTech COVID-19 vaccine.
contractpharma.com/content-microsite/covid-19/2021-02-12/evonik-strengthens-partnership-with-biontech-on-covid-19-vaccine?widget=listSection

(February 12, 2021) Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine
Pfizer and BioNTech SE said that the U.S. government has exercised its option for an additional 100 million doses
of the Pfizer-BioNTech COVID-19 vaccine. This brings the total number of doses to be supplied by the companies to the U.S. government to 300 million.
Consistent with the agreements for the prior 200 million doses, the U.S. government will pay $1.95 billion for the additional 100 million doses.
Pfizer’s facility in Kalamazoo, MI, remains the primary manufacturing site of the Pfizer-BioNTech COVID-19 vaccine in the U.S.
contractpharma.com/content-microsite/covid-19/2021-02-12/pfizer-biontech-to-supply-the-us-with-100mn-additional-doses-of-covid-19-vaccine?widget=listSection

(February 17, 2021) Pfizer, BioNTech To Supply 200M More Vax Doses to EU
Pfizer Inc. and BioNTech SE have entered an agreement with the European Commission (EC) to supply an additional 200 million doses of COMIRNATY,
the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states. The EC has the option to request supply of an additional 100 million doses.
This new agreement is in addition to the 300 million doses that have already been committed to the EU through 2021 under the first supply agreement signed last year.
The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.
The total number of doses to be delivered to the EU member states by the end of 2021 is now 500 million,
with the potential to increase to 600 million based on the option granted in the new agreement.
contractpharma.com/content-microsite/covid-19/2021-02-17/pfizer-biontech-to-supply-200m-more-vax-doses-to-eu?widget=listSection

(February 25, 2021) AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
Albany Molecular Research, Inc. (AMRI), a leading global provider of advanced contract research, development and manufacturing solutions,
today announced that the company has been chosen to support the development and manufacture of lipid excipients for the Pfizer-BioNTech COVID-19 vaccine.
For the past several months, AMRI has been providing development, scale-up and manufacturing services at a number of its global R&D and production sites,
demonstrating operational flexibility and expertise to deliver capacity for lipid excipient supply for the vaccine
at unprecedented speed to support the program. This critical lipid excipient surrounds and protects the vaccine’s active ingredient.
contractpharma.com/content-microsite/covid-19/2021-02-25/amri-contributes-to-efforts-to-increase-covid-19-vax-supply?widget=listSection

(February 25, 2021) Pfizer Partners with Medicines Manufacturing Innovation Center
CPI has formed an agreement with Pfizer, making it the newest partner of the Medicines Manufacturing
Innovation Center collaboration. The partnership will enable the Center to draw upon Pfizer's
expertise within the pharmaceutical sector to help address key challenges
and maximize efficiency within the medicines supply chain.
The Medicines Manufacturing Innovation Center is a collaboration between CPI,
the University of Strathclyde and founding industry partners GSK and AstraZeneca,
with funding provided by Scottish Enterprise and UK Research and Innovation.
contractpharma.com/contents/view_breaking-news/2021-02-25/pfizer-partners-with-medicines-manufacturing-innovation-center/53332

(February 26, 2021) U.S. FDA Authorizes Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
The U.S. Food and Drug Administration announced on February 25, 2021, that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine
o be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks.
The alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution
(which can be held in the refrigerator for up to 5 days) or on the storage of thawed vials after dilution
(which can be held at refrigerator temperature or room temperature for use within 6 hours).
precisionvaccinations.com/vaccine-breaking-news

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Post by Abacus Sat Mar 13, 2021 7:06 pm

(March 8, 2021) New Zealand to buy enough Pfizer doses to vaccinate entire population
The government has signed an agreement to buy an extra 8.5 million doses, enough to vaccinate over 4 million people,
Ardern said, adding the vaccines were expected to reach the country in the second half of the year.
New Zealand started its national rollout of the Pfizer-BioNTech's Covid-19 vaccine last month
and expects to inoculate its entire population by the end of the year.
Auckland, New Zealand's biggest city, emerged on Sunday from a strict week long lockdown
imposed after a community cluster of the more contagious British coronavirus variant. It reported no new cases on Monday.
france24.com/en/asia-pacific/20210308-new-zealand-to-buy-enough-pfizer-doses-to-vaccinate-entire-population

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Post by Abacus Sat Mar 13, 2021 7:07 pm

(March 10, 2021) The EMA covid-19 data leak, and what it tells us about mRNA instability
The BMJ has reviewed the documents, which show that regulators had major concerns
over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.

In short, commercial manufacturing was not producing vaccines to the specifications expected,
and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer,
along with a host of other questions it wanted addressed. The email identified “a significant difference in % RNA integrity/truncated species”
between the clinical batches and proposed commercial batches—from around 78% to 55%.


The root cause was unknown and the impact of this loss of RNA integrity
on safety and efficacy of the vaccine was “yet to be defined,” the email said.
It is an issue relevant not just to Pfizer-BioNTech’s vaccine but also to those produced by Moderna, CureVac, and others,
as well as a “second generation” mRNA vaccine being pursued by Imperial College London.
bmj.com/content/372/bmj.n627

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Post by Abacus Mon Mar 29, 2021 9:42 pm

(March 13, 2021) Japan to get 100 million doses of Pfizer vaccine by June
Japan is set to receive about 100 million doses of Pfizer Inc.'s COVID-19 vaccine through May and June,
the minister in charge of vaccination efforts has said, enough for nearly half of its population. The shipments from the drugmaker's factory in Belgium
will need to be individually approved under the European Union's export controls, Taro Kono said at a news conference Friday.
Prime Minister Yoshihide Suga has pledged to secure COVID-19 vaccines for Japan's population of 126 million within the first half of 2021.
The vaccine developed by Pfizer and its partner BioNTech SE, the only one the health ministry has approved so far,
consists of two shots, meaning 100 million doses will be enough for 50 million people.
The fifth batch of the Pfizer vaccine, about 420,000 doses, will arrive in Japan on Monday,
according to Kono. The country received its first shipment last month.
japantimes.co.jp/news/2021/03/13/national/pfizer-coronavirus-vaccines-june/

(March 26, 2021) EMA Approves BioNTech's COVID Vax Production at Marburg Site
BioNTech SE received approval from the European Medicines Agency (EMA) for the manufacture of the COVID-19 vaccine drug product at its facility in Marburg,
one of BioNTech’s largest mRNA vaccine manufacturing sites in Europe with an annual production capacity of up to one billion doses
of its COVID-19 vaccine, once fully operational. Due to optimized operational efficiencies which were initiated last year,

BioNTech has been able to increase the expected annual manufacturing capacity by 250 million doses.
Currently, 400 BioNTech employees work in Marburg. The first batches of vaccines
manufactured at the Marburg site are expected to be delivered in the second half of April.

The vaccine, which is based on BioNTech’s mRNA technology, was developed by both BioNTech and Pfizer.
BioNTech is the Marketing Authorization Holder in the EU, and the holder of emergency use authorizations
or equivalent in the US, United Kingdom, Canada and other countries in advance of a planned application
for full marketing authorizations in these countries.
contractpharma.com/content-microsite/covid-19/2021-03-26/ema-approves-biontechs-covid-vax-production-at-marburg-site?widget=listSection

(March 29, 2021) Pfizer Demands South African Ministers Personally Sign Vaccine Pact
Pfizer Inc. is demanding that South Africa’s health and finance ministers
personally sign a Covid-19 vaccine-supply agreement so that it is indemnified
from any claims made against it in the country regarding the shot.

The demand is contained in a March 24 letter from South Africa’s Health Minister Zweli Mkhize
to his finance counterpart Tito Mboweni, seen by Bloomberg and confirmed by the National Treasury.
Pfizer was not satisfied by assurances that the signature of the country’s health director general was sufficient to guarantee the indemnity, Mkhize said.
bloomberg.com/news/articles/2021-03-29/pfizer-demands-s-african-ministers-personally-sign-vaccine-pact


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Post by Abacus Sun Apr 18, 2021 8:25 pm

(April 9, 2021) NIH begins study of allergic reactions to Moderna, Pfizer-BioNTech Covid-19 vaccines
A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder
are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer-BioNTech Covid-19 vaccines.
In addition, investigators will examine the biological mechanism behind the reactions and whether a genetic pattern
or other factors can predict who risk is at most.

Study staff will collect blood, urine and nasal swabs from participants before each injection, and blood and urine after each injection.
If a significant number of systemic allergic reactions to either or both vaccines occur during the trial,
investigators will analyze these biological samples to examine possible mechanisms
for the reactions and whether certain genetic patterns are associated with higher risk.
Results are expected in late summer 2021.
pharmabiz.com/NewsDetails.aspx?aid=136659&sid=2

(April 9, 2021) Pfizer CEO says third Covid vaccine dose likely needed within 12 months
Pfizer CEO Albert Bourla said people will “likely” need a booster dose of a Covid-19 vaccine within 12 months
of getting fully vaccinated. His comments were made public Thursday but were taped April 1.
Bourla said it’s possible people will need to get vaccinated against the coronavirus annually.
cnbc.com/2021/04/15/pfizer-ceo-says-third-covid-vaccine-dose-likely-needed-within-12-months.html

(April 18, 2021) The ‘secret’ contracts for Pfizer and Moderna vaccines: the exclusive of “Report”
The European Union has kept them hidden for months: first it refused to publish them, then it covered sensitive data with a series of omissions.
The transmission of Rai 3 came into possession of the contracts and published in full the first contracts
for the purchase of the anti-Covid vaccines stipulated by Brussels at the end of 2020 with Pfizer and Moderna.

The figure of € 15.50 per dose for the Pfizer-Biontech vaccine which has been talked about for months, in fact, is not exactly correct.
That’s just the average between two different prices agreed with the pharmaceutical company.
The contracts also confirm that, in the event of damage from side effects, the compensation will fall almost exclusively on the states.

Patents, on the other hand, remain in private hands, despite the indemnity and public funding.
ruetir.com/2021/04/18/the-secret-contracts-for-pfizer-and-moderna-vaccines-the-exclusive-of-report/



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Post by Abacus Mon Apr 19, 2021 9:44 pm

(April 19, 2021) Pfizer, BioNTech Expand COVID-19 Vaccine Agreement with EU
Pfizer Inc. and BioNTech SE have inked a deal to supply an additional 100 million doses of COMIRNATY,
the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.
This announcement is a result of the European Commission’s (EC) decision to exercise
its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement
signed on February 17, 2021. This brings the total number of doses to be delivered to the EU to 600 million.
COMIRNATY will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe.
contractpharma.com/content-microsite/covid-19/2021-04-19/pfizer-biontech-expand-covid-19-vaccine-deal-with-eu?widget=listSection

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Post by Abacus Mon May 03, 2021 10:17 pm

(February 5, 2021) India: Pfizer withdraws COVID vaccine application for emergency use
Pfizer Inc. said on Friday that it has pulled out an application for emergency use authorization of the BioNTech-Pfizer coronavirus vaccine in India.
The decision came after Pfizer representatives met with India’s health regulator on Wednesday,
who refused to grant the pharmaceutical's vaccine the authorization, citing a lack of immunogenicity trials.
The company said that it would shortly submit another authorization request with further information when available.
India's drug regulator wanted Pfizer to conduct local trials to ensure the safety of the vaccine for official authorization.
But the company failed to present evidence that its vaccine was safe for the Indian population,
according to a Central Drugs Standard Control Organization (CDSCO) statement.
dw.com/en/india-pfizer-withdraws-covid-vaccine-application-for-emergency-use/a-56462616

(May 3, 2021) Pfizer donates $70 mn medical supplies to India, seeks quick vaccine approval
US pharma giant Pfizer has donated medical supplies worth $70 million,
including drugs to treat Coronavirus disease (Covid-19), to India,
the company said in a statement on Monday, adding
it was in talks with the Indian government to expedite its Covid-19 vaccine approval in India.
hindustantimes.com/india-news/pfizer-donates-70-mn-medical-supplies-to-india-seeks-expedited-vaccine-approval-101620037681235.html

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Post by Abacus Tue May 11, 2021 11:50 pm

(May 11, 2021) Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents
Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA)
for their COVID-19 vaccine to include individuals 12 to 15 years of age.
This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.
The emergency use of this product is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency use
of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
globenewswire.com/news-release/2021/05/11/2226850/0/en/Pfizer-and-BioNTech-Receive-First-U-S-Authorization-for-Emergency-Use-of-COVID-19-Vaccine-in-Adolescents.html



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Post by Abacus Sun Jun 27, 2021 11:21 am

(May 11, 2021) BioNTech to establish regional headquarters for Southeast Asia and mRNA manufacturing facility in Singapore
BioNTech SE announced plans to expand its global footprint to Asia
with the establishment of its regional headquarters for Southeast Asia in Singapore.
In addition to selecting Singapore as its future regional headquarters,
BioNTech plans to establish a fully integrated mRNA manufacturing facility
in Singapore with support from the Singapore Economic Development Board.
The new facility will provide regional and global supply capacity
of BioNTech’s growing pipeline of mRNA-based product candidates,
as well as a rapid response production capability for southeast Asia to address potential pandemic threats.
pharmabiz.com/NewsDetails.aspx?aid=138393&sid=2

(May 12, 2021) Fosun, BioNTech invest $200 M to manufacture COVID-19 vaccine in China
Shanghai Fosun Pharma has signed a Joint Venture with BioNTech to manufacture mRNA vaccine in China.
The JV will have capacity to manufacture 1 billion doses of the vaccine. Fosun will invest $100 million
to build the facility for its 50% share of the JV, while BioNTech will contribute its proprietary manufacturing technology,
which it values at $100 million.
In March 2020, the two companies partnered China development of the COVID-19 vaccine in a $135 million deal.
Fosun invested $50 million in BioNTech stock and agreed to pay up to $85 million in milestones. The term of the Joint venture is 15 years.
biospectrumasia.com/news/37/18178/fosun-biontech-invest-200-m-to-manufacture-covid-19-vaccine-in-china.html

(May 28, 2021) Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents
NEW YORK and MAINZ, GERMANY, May 28, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA)
for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age.
In addition, the pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children 6 months to 11 years of age is ongoing.
Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an Emergency Use Authorization
(e.g., in the U.S.) or a variation to Conditional Marketing Authorizations (e.g., in the EU) for two cohorts, including children 2-5 years
of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.
globenewswire.com/news-release/2021/05/28/2238459/0/en/Pfizer-and-BioNTech-Receive-First-Authorization-in-European-Union-for-COVID-19-Vaccine-in-Adolescents.html

(June 4, 2021) Pfizer coronavirus vaccine approved for use in children aged 12 to 15 in UK
UK regulators have approved the Pfizer vaccine for children aged 12 to 15.
The announcement was made this morning by the Medicines and Healthcare products Regulatory Agency (MHRA)
following safety testing on the vaccine. Until now it has only been licensed for adults in the UK.

It follows a similar move by the EU's medicines agency (EMA) last week,
while the governments in the US and Canada approved the vaccine for adolescents last month.

It will be down to the Joint Committee on Vaccination and Immunisation (JCVI)
to decide whether to go ahead and inoculate this age group, the MHRA said.
Germany and Poland are both set to start vaccinating children in this age group next week,
with France also set to start inoculating teenagers this month.
mirror.co.uk/news/uk-news/breaking-pfizer-covid-vaccine-approved-24248860

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Post by Abacus Sun Jun 27, 2021 11:23 am

(June 22, 2021) Pfizer says won’t make exception for India in its global approach for vaccine supply
Pfizer and Moderna have been insisting on indemnity or a liability shield against potential lawsuits relating to vaccine-related adverse events.
Pfizer says countries it is supplying vaccines have agreed to indemnify it for civil-legal claims as part of the purchase pacts.
India has not agreed to this so far, although it has been reported that it may grant indemnity.
Granting indemnity will mean that there will be a shift of liability from the manufacturer to the government.
The government will have to create a compensation mechanism for individuals if there is a damaging side effect.
moneycontrol.com/news/business/companies/pfizer-says-wont-make-exception-for-india-in-its-global-approach-for-vaccine-supply-7071881.html

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