Pfizer criticized the UK’s decision to lengthen the gap between doses of its Covid-19 vaccine, saying the “safety and effectiveness” of the new schedule had not been evaluated because infections and hospitalizations continued to skyrocket across the UK.
The rare intervention by the U.S. pharmaceutical company came amid growing controversy over the move, with GPs complaining about having to cancel appointments and reassure anxious patients who were previously told they needed to. the second dose to protect them.
“[Our] study . . . was designed to assess the safety and effectiveness of the vaccine on a two-dose schedule, separated by 21 days, ”the company said.
“The safety and efficacy of the vaccine have not been evaluated over different dosing regimens because the majority of trial participants received the second dose within the window specified in the study design.”
The new dosing guidelines, approved by the UK Joint Committee on Vaccination and Immunization and unveiled on Wednesday, allow the second dose of the vaccine Pfizer developed with BioNTech and the newly approved Oxford / AstraZeneca vaccine to be administered until three. months after the first.
The change aims to deliver a first dose of vaccine to as many people as possible, in a bid to counter the skyrocketing number of cases caused by a viral variant of the coronavirus that has proven to be much more infectious.
There was new evidence Thursday of the toll the virus is making in the UK, with 964 more deaths announced and new signs of strain on hospitals.
NHS Providers, which represent health organizations across the UK, said pressure on Covid-19 was mounting, particularly in London and the south-east, where the admissions surge in recent days was “extremely disturbing”.
Saffron Cordery, deputy managing director of NHS Providers, said that on Wednesday 22,713 patients with Covid-19 were hospitalized in England – an increase of more than 27% in seven days. “During the same period, the number of patients with Covid-19 in intensive care beds increased by 35%,” she added.
Matt Hancock, Britain’s Health Secretary, sought Thursday to counter suggestions that the vaccination program, which the government considers essential to tame the pandemic, was lagging behind.
He said 944,539 people across the UK received their first dose of a Covid-19 vaccine. “The NHS has a clear vaccine delivery plan and today’s figures once again show how our fantastic NHS has managed to tackle this huge task. . . Now that we have cleared a second vaccine, we can expect that number to increase rapidly in the coming months.
Although partial vaccine protection appears to start as early as 12 days after the first vaccine, Pfizer stressed that two doses were needed to provide maximum protection against the disease, with an effectiveness rate of 95%. Importantly, he said: “There is no data to show that protection after the first dose is maintained after 21 days.”
The drugmaker said decisions on alternative dosing regimens were in the hands of health officials and remained committed to talking to regulators, but stressed that every recipient should receive the maximum protection possible, “which means vaccination with two doses of the vaccine ”.
The Medicines and Health Products Regulatory Agency said, “The decision was made to update the dosing interval recommendations for the BioNTech / Pfizer vaccine after an extensive review of the data by the working group. experts on the risks of the MHRA’s Covid-19 vaccine benefits. This expert group concluded that the efficacy of the vaccine will be maintained with administration intervals of more than 21 days. ”
GPs across the UK have expressed anger and concern over the change, saying they need to spend time canceling appointments for people who expect to receive their supplement doses in the coming days.
Helen Salisbury, a general practitioner in Oxford, described the situation as “a shambles” and calculated that the network of practices administering the vaccine for her area would take 193 hours of staff time to reschedule appointments.
She questioned the judgment and the data modeling behind the decision. “What does science say? We do not know.
The British Medical Association has said that asking general practitioners to change the appointments of tens of thousands of elderly and vulnerable patients was “unreasonable and totally unfair, and practices that honor existing appointments booked for the next few days should be supported ”.
In his New Year’s message, British Prime Minister Boris Johnson praised the Oxford vaccine, saying it “literally brings new life to people in this country and around the world”.
However, he warned of “a hard struggle that still awaits us for weeks and months, as we face a new variant of the disease that requires new vigilance.”
Four questions about the Oxford / AstraZeneca vaccine rollout in the UK
Why is there a six-day delay between regulatory approval and
first vaccinations with the Oxford / AZ vaccine?
The vaccines are to be delivered and stored under conditions set by the UK medicines regulator, MHRA, which were not known until the approval was announced on Wednesday.
What other factors are delaying the deployment of the new vaccine?
Jonathan Van-Tam, deputy chief medical officer, said this week that “the only thing that will slow us down is the batches of vaccine that become available”. This, he said, was not just about the manufacture of vaccines, but also the “filling and finishing” – the process of bottling and packaging the vaccine for distribution – which he said was “a extremely scarce resource around the world ”. The second factor delaying patient supply is the regulatory requirement that each batch of vaccine be checked for safety and quality before it can be administered to patients.
Changing the dosing schedule to one dose and one second after
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, aims to protect more people, faster. Without needing to withhold half the supply to give second doses to those who have already received protection, all available doses can be used immediately. However, perhaps made wary by previous great pandemic promises that have not materialized, the government and the NHS will not be drawn to how many others will be covered in a specific timescale as a result.
When can the UK reach the 2 million people target
The government is keeping its promise that all those over 50 and younger whose health is particularly vulnerable will have been vaccinated by the end of March. Boris Johnson on Wednesday promised “tens of millions of doses” by then. Simon Stevens, head of England’s NHS, said all members of priority groups were covered by “late spring”.