Yesterday, the United Kingdom’s MHRA granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine. It didn’t take long for the decision to generate criticism and questions.
Yesterday, the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine. It didn’t take long for the decision to generate criticism and questions.
For example, the European Medicines Agency (EMA), issued a blunt statement, arguing that its longer approval process for Europe was more appropriate because it was built on more complete evidence and required more checks than the procedures used by Britain.
The EMA expects to make a decision by December 29. The EU executive, a spokesman for the European Commission, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine” because it was based on more evidence.
Pfizer’s UK Country Manager Ben Osborn responded, saying, “We have provided complete data packages, the unblinded data, to both regulators. I think what you’re seeing is just the difference in the underlying process and timelines, as opposed to any difference in data submission.”
The UK also pushed back, with June Raine, head of Britain’s MHRA, saying, “The way in which the MHRA has worked is equivalent to all international standards. Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received.”
There are apparently a few background issues underlying the controversy. Britain is still subject to EU rules until it fully leaves the European Union at the end of the year. However, under EU rules, although the Pfizer vaccine requires authorization by the EMA, EU countries can use an emergency procedure to distribute a vaccine in their own countries for temporary use.
In the U.S. the Pfizer-BioNTech vaccine data is being reviewed, with an advisory committee meeting scheduled for December 8, 9 and 10.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN, “The way the FDA is, our FDA is doing it, is the correct way. We really scrutinize the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine. I think if we did any less, we would add to the already existing hesitancy on the part of many people to take the vaccine because they’re concerned about safety or they’re concerned that we went too quickly.”
In polls, anywhere from half to two-thirds of Americans have suggested they might not take the vaccine until more testing has been conducted. Meanwhile, as of today, there have been 64,648,033 cases of COVID-19 around the globe with 1,495,919 deaths. In the U.S. alone, there have been 13,925,990 cases and 273,847 deaths.
“So,” Fauci added, “it’s almost a damned if you do and you’re damned if you don’t, because if you go quickly and you do it superficially, people are not going to want to get vaccinated. We have the gold standard of a regulatory approach with the FDA. The UK did not do it as carefully and they got a couple of days ahead. I don’t think that makes much difference. We’ll be there. We’ll be there very soon.”
The UK indicated yesterday they expected to begin dosing next week. Jonathan Van-Tam, England’s deputy chief medical officer, told BBC, “We expect to receive [the Pfizer vaccine] very shortly in the UK, and I do mean hours, not days.” He also said he expected the U.S. and European regulators to approve within days or a few weeks.
The UK’s vaccination program prioritizes older people in nursing homes and its workers followed by “everyone aged 80 and over” and “these with threat circumstances,” said Van-Tam.
He also noted that the UK was not relying on the Pfizer-BioNTech vaccine alone, saying, “There are extra vaccines coming, we have invested in seven others and they need to begin coming in by spring.”
In particular, he noted the AstraZeneca-Oxford vaccine, which requires less cold handling and storage than the Pfizer-BioNTech vaccine, might be available by Christmas.
The UK is planning to have about 800,000 initial doses in December, enough to completely dose 400,000 people (it requires two doses, about 28 days apart). Physicians are planning around-the-clock inoculations at hospitals and vaccination centers.
A survey conducted by the European Centre for Disease Prevention and Control (ECDC) indicated that 31 EU/EEA countries and the UK are planning to prioritize “older age groups, healthcare workers and persons with underlying conditions.” Nine of the countries, Austria, Belgium, the Czech Republic, France, Luxembourg, the Netherlands, Spain, Sweden and the UK have published more detailed plans. The report indicated those plans might be modified as more evidence about the virus’s “epidemiology and characteristics of vaccines, including information on vaccine safety and efficacy by age and target group.”
There are similar priorities in the U.S. On Tuesday, the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices voted 13-1 in support of a priority scheme that focused on frontline healthcare workers and residents of long-term care facilities. Operation Warp Speed, the U.S. government’s group, has decided to distribute the vaccines (as they become available) to states based on population, and it is up to the states to implement the distribution along the priority plan, although the states may modify it.
In the U.S., there are about 21 million healthcare workers and about 3 million people living in long-term healthcare facilities.
