After describing the U.K.’s swift Covid-19 vaccine approval as “rushed” and less careful than in the U.S., America’s top infectious disease official Dr. Anthony Fauci has backtracked and apologized during a BBC interview, saying that he has “a great deal of confidence” in the British regulator and did not mean to “imply any sloppiness even though it came out that way.”
After the U.K. became the first country to approve a Covid-19 vaccine Wednesday, Fauci, who has served six presidents in his nearly four-decade-long tenure as head of the National Institute of Allergy and Infectious Diseases, criticized the speed at which the MHRA, Britain’s medicines regulator, made the decision, suggesting it had “rushed” and cut corners to be the first.
Fauci later apologized, saying that he had “no judgement on the way the U.K. did it.”
The U.S. approval process — which has a number of labor-intensive requirements that the British process avoids — simply takes more time to complete than the British one, Fauci explained.
“That’s just the reality,” he said, adding that this does not mean the U.K. process is deficient.
The first batch of the Pfizer-BioNTech vaccine arrived in the U.K. from Belgium Friday, with elderly people in care homes and care home staff slated for vaccination first.
Britain currently stands alone in having approved a Covid-19 vaccine based on clinical data, authorizing the Pfizer-BioNTech vaccine Wednesday. This will likely remain the case for a number of days or even weeks, with meetings necessary for the approval process in Europe and the U.S. not scheduled to take place until next week at the earliest. Fauci was not alone in criticizing the British regulator, and its European colleagues were clearly unimpressed with its decision to break rank and make a unilateral decision on the matter, something British politicians incorrectly attributed to a new increase in regulatory freedom thanks to Brexit.
What To Watch For
As vaccines begin to be approved around the world, the biggest challenge shifts from development to distribution and implementation. Inevitably, there will not be enough vaccine supply to meet initial demand, even in the wealthy countries that have hoarded supplies. Meanwhile, supply chain issues will come to the fore and begin to dominate discussion and political agenda, and the international police agency Interpol warned of an onslaught of organized crime targeting vaccines. Separately, logistical issues are already cropping up: Pfizer’s vaccine is notoriously difficult to transport owing to its ultra-cold storage temperatures and the pharma giant has already slashed its predicted output for the year by half.
In announcing the decision to approve the Pfizer-BioNTech vaccine, chief executive of the U.K.’s medical regulator, Dr. June Raine, stressed that “the public’s safety has always been at the forefront of our minds” adding that the organization is “globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine.”