Understanding The UK’s Fast Approval Of The Pfizer-BioNTech COVID-19 Vaccine : Shots – Health News – NPR

The U.K. has approved use of the COVID-19 vaccine developed by Pfizer and BioNTech. Dogukan Keskinkilic/Anadolu Agency via Getty Images hide caption

The U.K. has approved use of the COVID-19 vaccine developed by Pfizer and BioNTech.

The United Kingdom gave emergency approval this week to a COVID-19 vaccine, and plans to begin rolling it out next week. Though Russia had previously approved a vaccine, the U.K. is the first country where regulators approved a vaccine that is backed by transparent science. The U.S. Food and Drug Administration will consider granting its regulatory approval next week.

Pfizer and BioNTech, a German firm, which developed the vaccine, say it is 95% effective based on the latest clinical trial involving 43,000 subjects.

To learn more about the vaccine and what the U.K.'s fast approval of it means, NPR spoke with Dr. Richard Hatchett, the chief executive officer of the Coalition for Epidemic Preparedness Innovations, which develops vaccines against emerging infectious diseases.

This interview has been edited for clarity and length.

What do you think of the news and how do you feel about it?

I'm pretty excited. I think the delivery of vaccines at this speed and with this degree of success is a tremendous testimonial to the power of science, and to the power of the scientific community, and industry and governments to come together to address a threat to the world. I hope it will inspire people and I hope it will give people hope.

By traditional standards of vaccine development, this is fast. Put that in perspective?

It's extraordinary. We're three hundred and twenty-three days, if I'm counting correctly, since the release of the viral sequences. We've gone from release of viral sequences to a brand new, previously unknown disease to the delivery of a product that now has this conditional licensure in the United Kingdom. That's never been done before. Previously, the fastest time from initiation of a vaccine development effort to an approved product was four years.

Does the speed of development of this vaccine and others give you any pause?

They have done the early stage trials, and then moved very rapidly into the later stage trials, but in a way that ensures that the later stage trials are large scale. They have sped up the development largely by, in parallel, making investments in manufacturing processes that ordinarily you might delay until you had data from your early stage clinical trials. They've taken the risks in the manufacturing process, but not taken risks with the clinical development. I think it's really important for people to understand that while the timelines have been compressed, they haven't cut corners with respect to proving safety or efficacy.

In the latest trial of this vaccine, 162 people injected with a placebo contracted the virus, while only eight injected with the vaccine contracted it. Are those good numbers?

Having a vaccine that shows 95% effectiveness, which is in the range of vaccines like the measles vaccine, is as good an outcome as we possibly could have expected.

What are the implications of the UK approving this vaccine before the U.S.? Does this put pressure on the U.S.?

Each national regulatory agency may come to different conclusionswhich is normalbecause each must make their own benefitrisk assessments. The FDA will meet on Dec 10 to discuss Emergency Use Authorization of the vaccine. It's important that each regulator follow its own processes, and make sound decisions that they can defend in the light of day.

How does the UK plan to roll out the vaccine?

The government has ordered enough doses to vaccinate 20 million people over time. The first priority group to receive the vaccine next week will be nursing home residents and their carers. Once this group has been vaccinated, subsequent groups will be prioritized by age and by underlying health conditions.

Unlike some other vaccines, this one has to be stored at -94 degree F. What are the implications of that?

Once you thaw it out and put it into a refrigerator, it has to be used essentially within five days or so, and that is going to be challenging in many environments. It may be possible to deliver that vaccine in the United States and the United Kingdom and other developed countries, but delivering a vaccine with those cold-chain requirements is going to present tremendous challenges in middle- and lower-income countries where it's desperately needed as well.

A YouGov poll Wednesday found one in five respondents weren't confident about the safety of the Pfizer/BioNTech vaccine. Do you think public compliance with vaccination will be a problem and, if so, what should the government do about it?

The increase in recent years of what is known as "vaccine hesitancy" is a major concern. Everybody in the scientific and public health communities has a role to play in building public trust and confidence in vaccines. That's why open and transparent communication about the rigorous clinical development processes that generate safety and efficacy data for these new vaccines is crucial. No corners are being cut.

Is there anything else that causes you concern here?

We still need to manufacture these vaccines at scale and we need to deliver them. That is a huge mountain to climb, and that will take time. You may have challenges on the manufacturing side that have nothing to do with the safety and effectiveness of the vaccine. So, we do still have a long way to go before this pandemic is behind us. People are going to need to continue to protect themselves from disease, protect their loved ones from disease, and try to comply with public health recommendations.

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Understanding The UK's Fast Approval Of The Pfizer-BioNTech COVID-19 Vaccine : Shots - Health News - NPR