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BIONTECH SE

(BNTX)
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Pfizer and BioNTech's Covid-19 Vaccine Wins U.K. Authorization -- Update

12/02/2020 | 03:06am 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 punctuates a monthslong sprint by the two drugmakers, which teamed up earlier this year and then pulled ahead of two other Western pharmaceutical giants, 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. has ordered 40 million doses, enough to vaccinate 20 million people. The government said in early November it expected to receive 10 million doses before year-end. People familiar with the matter said the U.K. might only 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.

A panel of experts advising the Food and Drug Administration is planning to review the vaccine on Dec. 10. The FDA could authorize soon thereafter, and supplies should become available not long after that. Pfizer has already started shipping shots to distribution sites.

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.

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 EU, 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 EMA, which had been 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 more than 1,200 is experienced in the kind of drug-safety scrutiny the vaccines have attracted. 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.

The U.K. government has been among the world's most proactive in buying vaccines. It has now secured access to roughly 357 million doses from seven manufacturers. Given the current vaccines are expected to require two shots, that is enough to vaccinate the population 2.7 times over, providing some leeway if not all vaccines come to fruition.

The rapid authorization could provide a political boost to Prime Minister Boris Johnson, whose handling of the pandemic so far has been criticized from both sides of the political spectrum in the U.K. From his own party, lawmakers have argued his lockdowns have been too strict, while opposition parties say he was too slow to appreciate the threat of the coronavirus when it emerged. They point to expensive programs, such as a countrywide test-and-trace system, that have struggled to make an impact on infection rates.

The U.K. has suffered the fourth-highest death rate of the major European countries -- after Belgium, Spain and Italy -- and its economic performance has been among the weakest in the region this year. This week, a second national lockdown across England is set to end as new Covid-19 cases fall across most of the country and related deaths start to level off. England will then enter into a phase of regional restrictions, with curbs on hospitality businesses across much of the country.

Mr. Johnson's battle against Covid-19 has also been personal. In April, he was hospitalized in an intensive-care unit and received oxygen after testing positive and showing symptoms of the virus.

Write to Bojan Pancevski at bojan.pancevski@wsj.com, Jenny Strasburg at jenny.strasburg@wsj.com and Jared S. Hopkins at jared.hopkins@wsj.com

(END) Dow Jones Newswires

12-02-20 0305ET

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ASTRAZENECA PLC 0.57% 7941 Delayed Quote.7.82%
BIONTECH SE 0.70% 111.335 Delayed Quote.35.68%
EURO / BRITISH POUND (EUR/GBP) -0.29% 0.88533 Delayed Quote.-0.49%
MODERNA, INC. 4.22% 153.01 Delayed Quote.40.71%
PFIZER INC. 0.16% 37.335 Delayed Quote.1.28%
US DOLLAR / RUSSIAN ROUBLE (USD/RUB) -0.08% 75.1286 Delayed Quote.2.19%
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Financials
Sales 2020 497 M 604 M 604 M
Net income 2020 -329 M -400 M -400 M
Net cash 2020 936 M 1 138 M 1 138 M
P/E ratio 2020 -73,6x
Yield 2020 -
Capitalization 21 933 M 26 633 M 26 665 M
EV / Sales 2020 42,2x
EV / Sales 2021 2,70x
Nbr of Employees 1 800
Free-Float 92,4%
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Mean consensus OUTPERFORM
Number of Analysts 10
Average target price 92,65 €
Last Close Price 91,09 €
Spread / Highest target 22,0%
Spread / Average Target 1,71%
Spread / Lowest Target -36,8%
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Managers and Directors
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Ugur Sahin Chief Executive Officer
Helmut Jeggle Chairman-Supervisory Board
Sierk Pötting Chief Operating & Financial Officer
Özlem Türeci Chief Medical Officer
Christoph Huber Member-Supervisory Board
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