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BIONTECH SE

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Pfizer and BioNTech's Covid-19 Vaccine Wins U.K. Authorization -- 7th Update

12/02/2020 | 07:08pm EST

By Bojan Pancevski, Jenny Strasburg and Jared S. Hopkins

LONDON -- The U.K. became the first Western nation to grant emergency-use authorization for a Covid-19 vaccine, clearing a shot developed by Pfizer Inc. of the U.S. and BioNTech SE of Germany to be distributed in limited numbers within days.

The two-shot vaccine is also being reviewed by the Food and Drug Administration in the U.S., where a similar authorization could come later this month and a rollout before the end of the year.

The U.K. green light on Wednesday punctuates a monthslong sprint by the two drugmakers, which teamed up earlier this year and then pulled ahead of two other Western pharmaceutical companies, each with its own promising shot. Vaccines typically take years to bring to market.

It also marks a key milestone in efforts to translate a promising new vaccine technology into a widely available shot. It was developed, tested, authorized and is now poised to be distributed amid a pandemic that has sickened tens of millions of people and killed more than 1.4 million around the world.

The U.K.'s emergence as the first Western country to get a vaccine is the result of fast work by the country's Medicines and Healthcare products Regulatory Agency. Britain is transitioning out of the European Union, with the exit fully kicking in Jan. 1. As a member of the bloc, authorization of the U.K.'s new drugs were in the past overseen by the European Medicines Agency, the EU regulator, which was based in London until Brexit prompted it to move to Amsterdam.

The MHRA in the past worked in close partnership with the EMA, handling a significant portion of the Europe-wide portfolio of medicines and medical devices awaiting authorization. As such, its staff of 1,320 is experienced in the kind of safety scrutiny the vaccines have attracted.

Brexit has meant the work the MHRA did for all of Europe was reduced significantly, freeing up knowledgeable staff to move quickly when vaccine data became available, according to researchers familiar with the agency. While drug authorization for British citizens is still in most cases in the hands of the EMA until the end of the year, the U.K. government used a long-held power to authorize a drug for emergency use, after the MHRA signed off on its safety.

A panel of experts advising the Food and Drug Administration is planning to review the vaccine on Dec. 10. The FDA could authorize soon after, and supplies should become available not long after that. Pfizer has already started shipping shots to distribution sites. Canada said it expects to complete soon its review of the Pfizer vaccine, possibly by mid-December. Canada has pledged to issue a decision regarding individual vaccine candidates at around the same time as the FDA and EMA.

The FDA and the EMA have defended their slower approach. Both agencies have rapidly compressed their own typical vaccine-approval timelines, and both are expected to make a decision on the Pfizer vaccine this month.

At the FDA's Dec. 10 public meeting, expert advisers will discuss emergency-use authorization of the vaccine. Scientists and other members of the public can submit comments beforehand. The next day, the EMA will host a virtual public meeting to talk about vaccine development and regulatory reviews.

Such meetings -- designed to bolster confidence in the regulatory process -- require extensive time and planning. Researchers say they might help address people's hesitancy to take vaccines.

The FDA is expected to make a decision on the Pfizer shot a few days after the Dec. 10 meeting. The FDA scheduled the public meeting last month, in part to assure the public it wasn't being rushed by political considerations. It is expected to rule on a vaccine from Moderna Inc. a short time after it makes a call on the Pfizer shot.

FDA Commissioner Stephen Hahn told ABC News on Tuesday that the agency would take the time necessary to perform its own analysis. Mr. Hahn was ordered to provide a timeline for approval of a Covid-19 vaccine in a meeting Tuesday with President Trump's chief of staff, Mark Meadows, according to people familiar with the events. Mr. Meadows demanded to know why the FDA hadn't yet approved a Covid-19 vaccine even though British regulators appeared to be on the verge of doing so, the people said.

Robert Redfield, director of the Centers for Disease Control and Prevention, signed a recommendation on Wednesday made by an advisory panel on distribution of the initial doses of vaccine in the U.S. The Advisory Committee on Immunization Practices said those doses should go both to health-care workers and nursing home residents. The recommendation has yet to be formally published, however.

Health and Human Services Secretary Alex Azar said Wednesday states should make the final decision on who gets the first doses, though they should use the CDC recommendation as a guide. "State leaders are in the best position to take our general national recommendations and translate them into more precise guidance for the state and its conditions," he said.

The U.K. has ordered 40 million doses, enough to vaccinate 20 million people. Health Secretary Matt Hancock said Wednesday the country is expecting an initial 800,000 doses to arrive in Britain next week. He said the speed at which vaccinations will take place will depend on how quickly the shot can be manufactured at a plant in Belgium, but the government is expecting "many millions" of doses by the end of the year.

"This will start small and ramp up. The vast majority of vaccinations we expect to be in the New Year," Mr. Hancock said in an interview with the British Broadcasting Corp.

People familiar with the matter said the U.K. might get four million to five million doses this year, but the number is in flux and will depend on production and other potential regulatory authorizations. The U.K. said it planned to use that limited supply to start vaccinating nursing-home residents and staff, and then move on to other highly vulnerable groups.

That sets up the U.K. as a potential test case for how distribution -- and uptake -- of the vaccine might unfold in other countries. The National Health Service, Britain's state-funded health system, runs hospitals across the country, and has been tapped to distribute the shots. The U.K. has also long been a battleground for vaccine skeptics, setting up a potential challenge here for the government: persuading people to get the shot.

Pfizer and BioNTech joined forces at the onset of the virus outbreak and edged ahead of two other promising vaccine candidates, one from Moderna Inc. and the other developed by the University of Oxford and AstraZeneca PLC.

Moderna's vaccine is being reviewed by the FDA as well and could be authorized for distribution in limited quantities in the U.S. by the end of the year. China and Russia have been vaccinating their populations with homegrown vaccines, too. The U.S., Europe and several other developed countries have held out hope for one or all of the three leading Western shots.

Results of clinical trials for each, disclosed over recent months, have raised hope that governments can quickly start inoculating their populations to build widespread immunity and begin to more confidently reopen businesses, schools and tourist destinations that have been closed, opened and then closed again amid the ebb and flow of the virus. When Pfizer and BioNTech first disclosed early, promising results, global stock markets shot higher.

Pfizer said last month that trials found its vaccine to be 95% effective in preventing symptomatic Covid-19. Moderna days later said its vaccine, developed with the same genetic technology upon which the Pfizer vaccine is based, showed efficacy of 94.5%.

Both vaccines use a new technology, leveraging mRNA, short for the molecular couriers called messenger RNA that carry genetic instructions to cells. The shots deliver mRNA that prompts cells to make a synthetic version of the spike protein that juts from the surface of the new coronavirus. That protein triggers the immune system to defend against the virus.

The shot developed by Oxford and AstraZeneca works like a more traditional vaccine, introducing a weakened virus, in this case one found in chimpanzees, into the body to trigger immunity. It showed an efficacy range of 62% to 90%, depending on the dosage.

The U.K. has ordered its medicines regulator to review that vaccine for emergency use, too. AstraZeneca is still conducting trials in the U.S. and is expected to submit its vaccine to the FDA once it has enough data.

The European Medicines Agency, the top medical regulator for the European Union, has said it hopes to authorize at least one of the three vaccines by the end of the year.

Russia, which was criticized in the West over the speed of development, has claimed its vaccine has efficacy of more than 90%. Chinese developers haven't provided data from the final clinical trials of their shots.

People who have worked with the U.K. agency in recent months say it has been more proactive in cooperating with drug companies as they provide data, asking additional questions and requesting more information that could speed a review. Like the FDA and the EMA, the U.K. regulator has received data on a rolling basis. Recently, the MHRA's rolling review has been a "much more interactive experience," said Sarah Blagden, associate professor of experimental cancer therapeutics at the University of Oxford, who oversees cancer trials. "The regulators become part of the discussion very, very early on," she added.

(MORE TO FOLLOW) Dow Jones Newswires

12-02-20 1907ET

Stocks mentioned in the article
ChangeLast1st jan.
ASTRAZENECA PLC -1.00% 7645 Delayed Quote.5.43%
BIONTECH SE -1.39% 103.15 Delayed Quote.28.93%
EURO / BRITISH POUND (EUR/GBP) -0.35% 0.88649 Delayed Quote.-0.46%
MODERNA, INC. -0.06% 124.98 Delayed Quote.19.66%
PFIZER INC. -0.54% 36.515 Delayed Quote.-0.22%
US DOLLAR / RUSSIAN ROUBLE (USD/RUB) -0.46% 73.438 Delayed Quote.0.12%
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Sales 2020 497 M 602 M 602 M
Net income 2020 -329 M -399 M -399 M
Net cash 2020 936 M 1 133 M 1 133 M
P/E ratio 2020 -69,7x
Yield 2020 -
Capitalization 20 770 M 25 210 M 25 147 M
EV / Sales 2020 39,9x
EV / Sales 2021 2,53x
Nbr of Employees 1 800
Free-Float 92,4%
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