UK analyst on COVID vaccine development: 'no issue' on the safety of vaccine

British officials authorized a COVID-19 vaccine for emergency use on Wednesday, greenlighting the world's first shot against the virus that's backed by rigorous science and taking a major step toward eventually ending the pandemic.

The go-ahead for the vaccine developed by American drugmaker Pfizer and Germany's BioNTech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and morgues in some places and forcing new rounds of restrictions that have devastated economies.

The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental while final testing is done.

Other countries aren't far behind: Regulators in the United States and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc. British regulators also are considering another shot made by AstraZeneca and Oxford University.

Health Secretary Matt Hancock said Britain expects to begin receiving the first shipment of 800,000 doses "within days,'' and people will begin receiving shots as soon as the National Health Service gets the vaccine.

Doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.

Professor David Harper, Senior fellow, Global Health Programme, Chatham House said the process of approval was something the UK regulator and the vaccine companies had been working on for some time.

"This isn't something that is an all or nothing that's just happened. There's been a very constructive dialog for some period. And the companies that are concerned in this case, Pfizer, have submitted the necessary data for the MHRA to make its assessment against those three criteria. And that's what has led to the approval that we've heard about this morning," Harper said.

"There is no issue of a compromise of the safety of the vaccine. The way that this has been done has been through constant contact with the regulators, as I said earlier, and this is something that is unprecedented. The amount of time that is taken to get this through to be an approved product is just absolutely astonishing. But there is no drop in the standards of assessment," he added.

A government committee will release details of vaccination priorities later Wednesday, but Hancock said nursing home residents, people over 80, and healthcare workers and other care workers will be the first to receive the shot.

Pfizer said it would immediately begin shipping limited supplies to the U.K. — and has been gearing up for even wider distribution if given a similar nod by the U.S. Food and Drug Administration, a decision expected as early as next week.

"No doubt it's a huge challenge logistically and administratively and all sorts of other ways, the U.K. is well prepared in this sense and had a lot of experience of immunization programmes," Harper said.

While the U.K. has ordered 40 million doses of the Pfizer vaccine, enough for 20 million people, it's not clear how many will arrive by year's end. Hancock said the U.K. expects to receive "millions of doses" by the end of this year, adding that the actual number will depend on how fast Pfizer can produce the vaccine.

One concern about the Pfizer-BioNTech vaccine is that it must be stored and shipped at ultra-cold temperatures of around minus 70 degrees Celsius (minus 94 degrees Fahrenheit), adding to the challenge of distributing the vaccine around the world.

Pfizer says it has developed shipping containers that use dry ice to keep the vaccine cool. GPS-enabled sensors will allow the company to track each shipment and ensure they stay cold, the company says.

"No doubt it's a huge challenge logistically and administratively and all sorts of other ways, the U.K. is well prepared in this sense and had a lot of experience of immunization programs," Harper said.

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