LONDON — The U.K. on Wednesday became the first country to authorize the Pfizer-BioNTech vaccine for emergency use, marking another step in the global battle against the pandemic.
The vaccine will now be rolled out in the country next week, with elderly people in care homes and medical workers first in line. The U.K. government is the first in the world to formally approve the U.S.-German vaccine for widespread use, and it means Britain will be one of the first countries to begin vaccinating its population. Emergency use approval in the United States is under review by the Food and Drug Administration.
“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,” the government said Wednesday. “The vaccine will be made available across the U.K. from next week.”
Pfizer’s Chairman and CEO, Dr. Albert Bourla, said the authorization was a “historic moment.”
“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 U.K.,” he said.
“With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”
Pfizer and BioNTech announced in July an agreement with the U.K. to supply 30 million doses of its mRNA-based vaccine, formally known as BNT162b2, once authorized for emergency use. That agreement was increased to 40 million doses in early October. As a two-dose vaccine, the U.K. will have enough doses to vaccinate around a third of its 66 million population.
BioNTech said Wednesday that the delivery of the 40 million doses will occur throughout 2020 and 2021, with complete delivery fulfilment expected next year.
A spokesman for the U.K.’s Department of Health and Social Care said it would soon be known which parts of the population would be the first to receive the vaccine.
“The Joint Committee on Vaccinations and Immunisations will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable,” he said.
The U.K.’s approval of the Pfizer vaccine, which was seen to be 95% effective at preventing Covid-19 in late-stage clinical trials, has prompted questions over when we could see regulators in the rest of Europe, and the U.S., make their respective decisions on whether to authorize the vaccine.
On Monday, Pfizer and BioNTech said they had applied to the European Medicines Agency for the conditional marketing authorization of the vaccine. If the authorization is granted, it could enable use of the vaccine in Europe this month, BioNTech said, although the EMA later said on Tuesday that it would complete its review of the vaccine by Dec. 29.
For its part, the Food and Drug Administration said in late November that it had scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Dec. 10 to discuss Pfizer and BioNTech’s request for the emergency use authorization of its vaccine, so a decision could be announced soon after.
Time is of the essence when it comes to rolling out a vaccine, particularly for the U.K. It has the third highest number of confirmed cases in Europe, after France and Spain, with over 1.6 million infections, according to data from Johns Hopkins University. It has seen the highest number of deaths due to the coronavirus in Europe, however, with almost 60,000 fatalities.
The number of daily infections has been steadily falling due to a second lockdown, that was lifted on Wednesday and replaced with a tiered system of restrictions, with the severity of the rules dictated by regional infection rates.
One EU lawmaker raised questions about the U.K.’s decision to authorize Pfizer’s vaccine.
“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way. A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorization of a vaccine,” said Peter Liese, a member of German Chancellor Angela Merkel’s party, according to Reuters.
Correction: EU lawmaker Peter Liese spoke on Wednesday. An earlier version had an incorrect day.
Source: Business - cnbc.com
