The UK accepts the world's first Pfizer-BioNTech COVID-19 vaccine

LONDON (Reuters) - On Wednesday, Britain approved the COVID-19 vaccine from Pfizer Inc, moving ahead of the rest of the world in the race to launch the most important mass inoculation program in history.

Prime Minister Boris Johnson, while recognizing the logistical difficulties of vaccinating an entire nation of 67 million, promoted the green light from Britain's medicine authority as a global victory and a ray of hope for the end of the pandemic.

The step by Britain raised hopes that the tide might soon turn against a virus that, since it appeared in Wuhan, China, a year ago, has killed nearly 1.5 million people worldwide, hammered the world economy and upended daily life for billions.

Emergency use approval was issued by the British Medicines and Healthcare Products Regulatory Agency (MHRA) for a vaccine developed by Pfizer and German biotechnology partner BioNTech, which they claim is 95 percent effective in disease prevention, just 23 days after Pfizer released the first data from its final clinical trial process.

"Great news," Johnson said to Parliament, although he warned that people should not be swept away.

"It is very very important at this point that individuals do not get their hopes too soon about the speed at which we can roll out this vaccine."

For months, foreign drug manufacturers and researchers have been racing to produce vaccines, and Britain's first authorization can be seen as a coup for a government that has faced criticism over its crisis management.

U.S. and EU regulators are sifting through the same data from the Pfizer vaccine trial, but their approval has yet to be granted.

The swift decision by Britain drew criticism from Brussels, where the EU regulator said in an unusually blunt statement that its longer process was more fitting and based on more facts.

His press secretary said Johnson could be persuaded to take a COVID-19 shot on television to prove that it was healthy, but he would not have one before anyone in greater need.

After receiving 800,000 doses from Pfizer's manufacturing center in Belgium, Britain said it would start vaccinating those most at risk of dying early next week and UK Health Secretary Matt Hancock said testing had been completed on the first batch.

Hours after the British announcement, the Russian authorities instructed President Vladimir Putin to launch mass voluntary vaccinations next week. Over the next few days, Russia will have developed 2 million doses of its own vaccine, Putin said.

Ralf Rene Reinert, Pfizer vaccine executive, said other nations were looking to imitate Britain.

The United Kingdom leads, and now let's see how the other countries are going on. And Pfizer will do everything to share with every regulatory agency all the data packages,' he said.

German Health Minister Jens Spahn said similar emergency permits may have been issued by EU Member States, but Europe had agreed to step forward as one.

"To help promote confidence and trust in this authorisation, it is very important that we do this," he said.

Until the transition period expires on Dec. 31, Britain is bound by European law, but has opted for emergency approval instead.

Asked if a "big Brexit bonus" was the speedy acceptance, Johnson instead credited global efforts.

The PM said It's a truly international thing and it's very very moving to see it."

Since July 2019, Pfizer shares have increased almost 4 percent to their peak, and the U.S.-listed shares of BioNTech have increased almost 5 percent since reaching record highs on Tuesday.

The world should turn a corner in curbing the pandemic over optimism, although the gains were more muted than those seen in November when Pfizer released the first results of the trial. Global stocks were also higher. [GLOB/MKTS]

In record time, the MHRA of Britain approved the vaccine by conducting a "rolling" simultaneous review of data and the development process as Pfizer raced to complete trials.

No corners have been cut," MHRA chief June Raine said in a Downing Street television briefing, adding that the first data on the vaccine was received in June and a rigorous international standards analysis was undertaken." "Our watchword is safety."

The approval of emergency usage does not come with any related volume limit or threshold, the country manager of Pfizer UK said.

"With 450 individuals dying every day in the UK from COVID-19 infection, the benefits of rapid vaccine approval outweigh the potential risks," said Andrew Hill, senior visiting research fellow at the University of Liverpool's Department of Pharmacology.

US. U.S. Health Secretary Alex Azar said trust should be inspired by the British move.

"It should be really calming for the American people. This vaccine has been found to be safe and appropriate for use by an independent regulatory authority in another country," Azar told Fox Business Network.

The U.S. Food and Drug Administration will make a decision in days or weeks after a group of external advisors meets on Dec. 10 to review the data and make its recommendation to the department on the emergency use authorization of the Pfizer/BioNTech vaccine.

The European Medicines Agency (EMA) said that by Dec. 29 it could grant emergency approval for the shot, while the World Health Organization said it was reviewing it for "possible emergency use listing."

Ugur Sahin, chief executive and co-founder of BioNTech, said The data submitted to regulatory agencies around the world is the result of a scientifically rigorous and highly ethical program of research and development."

The company said it expects decisions to be made by the FDA and EMA in mid-December.

Johnson said that life would not instantly return to normal, but now there was hope that things would change. He said the vaccines would not be necessary but strongly urged qualified individuals to take them.

The speed of the roll-out depends on how rapidly the vaccine can be manufactured and supplied by Pfizer - and the extreme temperature of -70C (-94F) at which it must be stored. It can be stored in a normal fridge for five days.

40 million doses of the Pfizer vaccine have been ordered by Britain - enough for just under a third of the population as two shots per person are required to achieve immunity.