The UK plans to postpone the required second dose of their authorized vaccines by up to 12 weeks – an attempt to speed up the distribution of the first dose. This public experiment is very controversial, as the second doses of the vaccines were granted three to four weeks after the first, according to the clinical trials.
“Bad idea,” said Dr. Paul Offit, a member of the Food and Medicine Vaccine Advisory Committee, said. “You’re disrupting a program,” he said, adding that if a recipient’s second dose is delayed, “two months later, three months later, four months later … they may no longer be protected.”
COVID-19 vaccine injections have lagged behind worldwide, and the U.S. has vaccinated just over 5 million of the approximately 20 million vaccines distributed across the country. With the new virus variant being launched in the UK and causing the second official shutdown, their health officials are gaining the upper hand.
“This is all we really see, day in and day out – more and more cases of this,” said Dr. Laith Alexander of the St. Thomas Hospital in the UK said Alexander received his first injection last month and said he did not agree to his second shot being delayed.
“The problem is that I agreed to the vaccination according to the schedule tested in the trial – in the phase three trial,” Alexander said. “I did not really agree to a schedule that ultimately did not have a randomized clinical trial behind it.”
The authorized vaccines in the UK – including those from Pfizer, AstraZeneca and Moderna – each require two doses. Each vaccine contains information showing that the vaccine may be moderately effective after the first shot, but not nearly as much as it would be without the second required dose.
“With the Pfizer [first dose], it was approximately 50% effective within the three week period, “Offit told ABC News regarding the data from the clinical trials against the vaccine.” For the Modern [first dose], about 80% within the four week period – but all that shows is that you have a very very short range of protection with the first dose, which can only last a few weeks. ‘
Offit is part of the advisory committee that voted for the FDA to authorize both Pfizer’s and Moderna’s COVID-19 vaccine candidates for emergency use in the United States.
“That second dose gives you an excellent boost response, as evidenced by the clinical trials,” Offit said. ‘It’s a mistake to postpone the second dose just because it sends a subtle message that the second dose may not be that important – while it’s critical because it’s what gives you the protection, and probably the long-term protection, your need for these vaccines. ‘
The World Health Organization also took the British plan into account, saying scientific evidence did not support a delay of more than six weeks in administering a second dose of vaccine.
Offit said there is no support among researchers at the FDA to delay second doses in the US. One option being discussed, however, is to administer only half the amount of Moderna vaccine when each dose is given, based on early results in 18- to 55-year-olds.
The idea was put forward by Moncef Slaoui, head of Operation Warp Speed, in an interview with CBS’s “Face the Nation” earlier this week.
“It makes even less sense than giving one dose and waiting,” Offit said when asked about Slaoui’s proposal. “I think it’s a dangerous, dangerous idea. And the Food and Drug Administration has certainly dispelled both of those ideas.”
Asked to comment, Moderna said: “At this stage we have no further information to share about possible ongoing regulatory talks.”
On Monday, the FDA issued a warning against experimenting with dosage. “We want to remind the public of the importance of receiving COVID-19 vaccines according to their authorization … to safely receive the level of protection observed in the randomized clinical trials,” the statement said.
injections in the US are still slower than officials originally promised, but dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the U.S. could soon vaccinate a million people a day.
Attention is still being paid to the ongoing clinical trials for the single-dose vaccine candidate for Johnson and Johnson. If the company proves to the FDA that the vaccine is safe and effective, injections could be accelerated from February with up to 100 million doses being distributed according to the company.