The European Medicines Agency (EMA) has defended its vaccine approval process as the UK announced temporary use of the Pfizer-BioNTech COVID-19 drug, saying its own procedure was more thorough, after Britain became the first Western country to endorse a COVID-19 shot.

The decision to give emergency authorization for the vaccine, seen by many as a political coup for UK Prime Minister Boris Johnson, who is leading the country out of the European Union, was made under an emergency approval process. This allowed the UK's drugs regulator to temporarily sign off the vaccine just 10 days after it started analyzing data from large-scale trials.

The European Medicines Agency (EMA), in charge of approving coronavirus vaccines for the EU, said its longer system for approving inoculations was more appropriate because it was based on more evidence and demanded more checks than the procedure followed in the UK. 

 

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The EMA said on Tuesday it would make a ruling on whether to provisionally authorize the Pfizer-BioNTech vaccine by December 29.

A European Commission spokesperson said the EMA's system was "the most effective regulatory mechanism to grant all EU citizens access to a safe and effective vaccine," as it was based on more evidence.

However, June Raine, the head of Britain's Medicines and Healthcare products Regulatory Agency (MHRA), defended the UK government's decision, saying: "The way in which the MHRA has worked is equivalent to all international standards."

 

 

Approval process

The EMA began reviewing preliminary data from Pfizer trials on October 6 in a bid to speed up its potential approval, a process that often takes more than seven months after receiving full data from trials.

The UK drugs regulator kick-started its own rolling review on October 30, looking at a smaller data sample than the EMA's.

"If you evaluate only the partial data as they are doing, they also take a minimum of risk," the EMA's former head Guido Rasi said to an Italian radio station.

"Personally, I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first," he added.

Under EU regulations, the vaccine must be signed off by the EMA, but EU countries can employ an emergency procedure that lets them distribute inoculations for temporary use. That applies to the UK, which still has to abide by EU rules until the end of its transition period from the bloc at the end of the year.

Peter Liese, an EU member of parliament, described the UK move as "problematic," adding: "A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorization of a vaccine."

 

 

UK's vaccine plans

The UK become the first country in the world to give regulatory approval to the drug, with plans already in place for the first vaccinations to be carried out early next week.

In a statement on the UK government's website, published on the same day the country exits its second period of lockdown, a spokesperson for the Department of Health and Social care said: "The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech's COVID-19 vaccine for use."

Prime Minister Boris Johnson's government has already said the initial doses will be used for those most at risk. Top of that list are care home residents and staff, people over 80 years old and health and social care workers.

The UK had already made an initial order for 40 million doses of the Pfizer-BioNtech vaccine earlier in the year, enough to treat 20 million people. The vaccine needs to be kept at -70 degrees Celsius to ensure its effectiveness – a requirement that could complicate the roll-out of the drug to sites that do not have the refrigeration technology to maintain such low temperatures.

In an interview with the BBC, UK health minister Matt Hancock said: "I'm confident now with the news today that from spring, from Easter onwards, things are going to be better and we're going to have a summer next year that everybody can enjoy."

 

 

Global race

The UK is not the first country to administer a vaccine to citizens, as China authorized the emergency use of the Sinovac Biotech candidate for high-risk patients in July and made it available for sale to citizens of the eastern city of Jiaxing in November. 

Also, Russia's President Vladimir Putin authorized the use of his country's Sputnik V vaccine in August, although phase three trials had not been completed at that stage.

The Pfizer-BioNTech team was the first biopharmaceutical company to release figures of phase three trials of a vaccine and the results surpassed scientists' expectations. More than 90 percent of those given the double dose injections showed an effective immune response to COVID-19 and the drug is now awaiting approval from European Union and U.S. regulators.

"This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK," said Pfizer CEO Albert Bourla.

"As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world."