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The new strategy, announced by the head of the UK drugs regulator MHRA on Wednesday, means the interval between doses could be extended up to 12 weeks, instead of the three weeks previously stipulated.
This has sparked debate among experts, the British Medical Association (BMA), a body representing British doctors, criticizing the decision to postpone the appointments of highly vulnerable patients who are currently awaiting their second injection.
The Pfizer / BioNTech vaccine has been in use in the UK since early December, when the country became the first in the world to approve it, but supplies are limited.
The vaccination strategy argument comes as infection rates skyrocket across much of the UK, in part thanks to a new, more infectious variant of the virus. Most of England is now under the strictest level of restrictions in an attempt to limit the spread of the virus.
“This group of very elderly patients are at the greatest risk of death if they contract Covid-19, which is why GPs are so concerned about them. It is clearly unfair to tens of thousands of our most at risk patients to date. try to postpone their appointments, ”said Dr Richard Vautrey, chairman of the BMA’s general practitioner committee, in a statement Thursday.
The U.K. Physicians’ Association also raised “real and serious concerns” about the new vaccination strategy, warning Friday that it could undermine the National Health Service’s patient consent process, “as well as failing to follow science completely “.
Meanwhile, Pfizer said it did not have data showing that a single dose of its vaccine would provide protection against the disease after more than 21 days.
“Pfizer and BioNTech’s Phase 3 study for the Covid-19 vaccine was designed to assess the safety and efficacy of the vaccine on a 2-dose schedule, separated by 21 days,” Pfizer said in a statement Thursday. “There is no data to show that protection after the first dose is maintained after 21 days.”
“The second dose of vaccine is likely to be very important for the duration of protection, and at an appropriate dose interval can further increase the effectiveness of the vaccine,” they said.
“In the short term, the further increase in vaccine efficacy from the second dose is likely to be modest; the vast majority of initial protection against clinical disease occurs after the first dose of vaccine.
‘Terrible impact’ on emotional well-being
The BMA warned in its statement that the delay could have a “terrible impact on the emotional well-being” of vulnerable and at-risk patients.
“The BMA believes these are patients who have already been promised by the NHS and local clinicians that they will receive a second dose of Pfizer vaccination next week; they have given their consent to receive it and, rightly so. , expect to have, ”said the BMA.
Vautrey, the chairman of the BMA, told CNN on Friday that medical professionals were particularly concerned about the “practicality of doing it so quickly,” with little warning given to practitioners over the revised guidelines.
“We were only told on the last day that we had to, next Monday, change all the appointments we made for next week … it just wasn’t practical for our practice staff to do so.” in so little time. space of time, ”Vautrey said.
“We wanted the commitments we made to our elderly patients to donate their vaccine to be honored, certainly in the coming days.”
Helen Salisbury, a general practitioner from the English city of Oxford, told the BBC’s Today show on Friday that her practice had yet to canceled second existing appointments next week. Indeed, on the one hand, it had not been able to find data on immunity after the first dose beyond the 21 days when the booster was administered in the trials, and on the other hand, because the practice wanted to protect its most vulnerable patients, the elderly and maintain their confidence in the vaccine.
“When you’ve started treatment on a patient and said, here’s the plan, here’s a shot, come back in three weeks, it’s really important that you have the second shot to be fully protected – and then to do a half-shot. turn five minutes later and say no, don’t worry about it, you can have it in 12 weeks rather than three weeks – I don’t think that’s good enough, actually, ”she said.
In their letter, the chief medical officers said they recognized the operational difficulties and the potential distress involved in postponing second appointments on short notice.
“However, we are all aware that for every 1,000 people who received a second dose of Covid-19 vaccine in January (who will thus gain marginally in protection against serious illness), 1,000 new people may not benefit from initial protection. substantial. is in most cases likely to raise them from 0% protected to at least 70% protected, ”they said.
Pfizer said it had not evaluated different dosing regimens because “the majority of trial participants received the second dose within the window specified in the study design.”
In its open letter, the Doctors’ Association UK wrote: “The protection provided by the first dose of Pfizer vaccine is considerably lower at 52.4% compared to 95% if two doses are given three weeks apart.”
Vautrey told CNN that greater assurances would be needed from the UK’s chief medical officers and Pfizer in order to give medical professionals and patients confidence in the government’s strategy.
“We need Pfizer themselves to be sure that this new dosing regimen will provide effective coverage and protection for our patients, especially our most vulnerable patients,” said Vautrey.
British regulators have also advised giving the second dose of the new Oxford / AstraZeneca vaccine, which is expected to be rolled out from Monday, four to 12 weeks later.
US also plans to space jabs
The strategy of lengthening the interval between the first and the second vaccine dose is also “under study” in the United States, said Thursday the director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci. .
To date, two vaccines have been approved for use in the United States, the Pfizer / BioNTech vaccine and another made by Moderna, which requires a second dose 28 days later.
“I still think, if done correctly, you can do a single dose, reserve doses for the second dose, and keep doing the job,” Fauci told NBC’s Today Show, “but there is has a lot of talk about whether you want to expand the initial vaccination by getting more people vaccinated in the first round. “
Fauci said it could be debated anyway, but a potential problem would be if a person didn’t get the second dose on time and there was a lag period.
He said clinical trials knew that “the optimal time is to give it one day, then for Moderna 28 days later and for Pfizer 21 days later, that’s what the data tells us is the best way to do it. make.”
If you want to stick to the data, this is the way it should be done, he said, “but you can argue, and some people are, to expand the doses by giving one dose to everyone. levels and hoping you are going to get the second dose in time to give it to individuals. “
British Prime Minister Boris Johnson made an optimistic note on vaccines in a speech on New Years Eve.
“We still have a tough fight ahead of us for weeks and months as we face a new variant of the disease that requires new vigilance,” he said.
“But as the sun rises tomorrow in 2021, we have the certainty of these vaccines. I believe 2021 is first and foremost the year when we will end up doing those everyday things that now seem lost in the past, bathed in a pink glow of nostalgia – going to the pub, concerts, theaters, restaurants or just holding hands with loved ones in the usual way. “
CNN’s Niamh Kennedy and Vasco Cotovio contributed to this report.
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