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Pfizer has criticized the UK’s decision to lengthen the gap between the doses of its Covid-19 vaccine, saying that the “safety and efficacy” of the new scheme has not been evaluated as infections and hospitalizations continue to rise across the UK. United.
The rare intervention by the US pharmaceutical company came amid mounting controversy over the measure, with GPs complaining they had to cancel appointments and reassure anxious patients previously given. he had said they needed the second dose to stay safe.
“[Our] study . . . it was designed to evaluate the safety and efficacy of the vaccine following a two-dose schedule, separated by 21 days, ”said the company.
“The safety and efficacy of the vaccine has not been evaluated in different dosing schedules, as the majority of trial participants received the second dose within the period specified in the study design.”
New dosing guidelines, approved by the UK Joint Vaccination and Immunization Committee and released on Wednesday, allow the second dose of the vaccine that Pfizer developed with BioNTech and the recently approved Oxford / AstraZeneca vaccine to be given up to three months after the first.
The change aims to deliver a first dose of vaccine to as many people as possible, in an attempt to counter the skyrocketing number of cases caused by a viral variant of the coronavirus that has been found to be far more infectious.
On Thursday there was new evidence of the toll the virus is taking in the UK, with another 964 deaths announced and new signs of tension in hospitals.
NHS Providers, which represents healthcare organizations across the UK, said Covid-19 pressures were intensifying, particularly in London and the South East, where the spike in admissions in recent days was “extremely concerning.”
Saffron Cordery, deputy executive director of NHS Providers, said there were 22,713 Covid-19 patients in a hospital in England as of Wednesday, an increase of more than 27 percent in seven days. “During the same period, the number of Covid-19 patients in intensive care beds increased by 35 percent,” he added.
Matt Hancock, the UK health secretary, on Thursday tried to counter suggestions that the vaccination program, which the government considers vital to controlling the pandemic, was being delayed.
It said 944,539 people across the UK had received their first dose of a Covid-19 vaccine. “The NHS has a clear vaccine delivery plan and today’s figures show once again how our fantastic NHS has risen to this enormous task. . . Now that we have licensed a second vaccine, we can expect this number to increase rapidly in the coming months. ”
Matt Hancock said that more than 940,000 people had received their first injection of the Covid-19 vaccine © Jessica Taylor / UK Parliament
Although partial protection through the vaccine appears to begin as early as 12 days after the first puncture, Pfizer emphasized that two doses were required to provide maximum protection against the disease, with an efficacy figure of 95 percent. Crucially, he said, “There is no data to show that protection after the first dose is maintained after 21 days.”
The drugmaker said that decisions on alternative dosing regimens are in the hands of health authorities and that it remains committed to speaking with regulators, but emphasized that each recipient should receive the maximum possible protection, “which means immunization with two doses of the vaccine”.
The Regulatory Agency for Medicines and Health Care Products said: “The decision was made to update the dose interval recommendations for the BioNTech / Pfizer vaccine after a comprehensive review of the data by the Expert Working Group. at Risk Benefit from MHRA Covid-19 Vaccines. This group of experts concluded that the efficacy of the vaccine will be maintained with dosing intervals greater than 21 days ”.
GPs in the UK expressed anger and concern over the change, saying they had to spend time canceling appointments for people who were expecting to receive their refill dose in the coming days.
Helen Salisbury, an Oxford GP, described the situation as “a disaster” and estimated that the network of practices administering the vaccine in her area would need 193 hours of staff time to reschedule appointments.
She questioned the judgment and data modeling behind the decision. What does science say? We do not know “.
The British Medical Association said that asking GPs to reschedule the appointments of tens of thousands of elderly and vulnerable patients was “unreasonable and totally unfair, and practices that respect existing appointments booked for the next few days should be supported. “.
In his New Year’s message, Boris Johnson, Prime Minister of the United Kingdom, praised the Oxford vaccine, saying it “literally offers a new lease of life to people in this country and around the world.”
However, he warned of “a tough fight that awaits us for weeks and months, because we are facing a new variant of the disease that requires new surveillance.”
Four questions about the Oxford / AstraZeneca vaccine launch in the UK
Why is there a six-day delay between regulatory approval and
first vaccinations with the Oxford / AZ vaccine?
The vaccines must be delivered and stored in accordance with conditions set by the UK’s drug regulator, the MHRA, which were not known until the approval announcement on Wednesday.
What other factors are delaying the rollout of the new vaccine?
Jonathan Van-Tam, deputy chief medical officer, said this week that “the only thing that is going to hold us back is the availability of vaccine batches.” This, he said, is “not just about vaccine manufacturing,” but also about “filling and finishing,” the process of putting the vaccine into vials and packaging it for distribution, which he said was “a critically scarce resource throughout the world. world”. The second factor delaying supplies to patients is the regulatory requirement that each batch of vaccine be checked for safety and quality before it can be administered to patients.
Does changing the dosing regimen to one dose and one second after
Does 12 weeks speed things up?
The decision to increase the intervals between doses, not only for the Oxford / AstraZeneca vaccine, but also for the BioNTech / Pfizer version, is aimed at protecting more people, more quickly. Without the need to withhold half the supply to give second doses to those who have already received a protective measure, all available doses can be used immediately. Yet perhaps wary of previous big pandemic promises that failed to materialize, the government and the NHS will not rely on how many more will be covered on a specific timescale as a result.
When will the UK be able to meet the target of 2 million people per
week of being vaccinated?
The government keeps its promise that everyone over 50, and younger people whose health is particularly vulnerable, will have been vaccinated by the end of March. Boris Johnson promised Wednesday “tens of millions of doses” at the time. Simon Stevens, director of the NHS England, has spoken that all priority groups will be covered by “late spring”.
