Pfizer has criticized the UK’s decision to lengthen the dose difference of its Kovid-19 vaccine, saying the “safety and efficacy” of the new schedule was not evaluated, as infections and hospitalizations continue across the UK are.
Amid growing controversy over the move, the US pharma company’s rare intervention led to doctors complaining that they had to cancel appointments and reassure anxious patients who had previously been told they needed a second dose to keep them safe needed.
“[Our] study . . . The vaccine was designed to evaluate safety and efficacy, which was set aside for 21 days according to a two-dose schedule, ”the company said.
“The safety and efficacy of the vaccine has not been evaluated on a different dosing schedule because most trial participants received a second dose within the window specified in the study design.”
The new dosing guidelines, approved by the UK Joint Committee on Immunization and Vaccination on Wednesday and unveiled on Wednesday, both allow a second dose of the vaccine, developed with Pfizer Biotech, and the newly approved Oxford / AstraZeneca vaccine, to To be distributed as three. After the first months.
The change is intended to give as many people as possible the first dose of the vaccine, in an attempt to combat spiraling case numbers caused by a viral version of coronovirus that has been found to be more contagious.
In Britain, there was fresh evidence of a toll virus on Thursday, with 964 deaths announced and new signs of stress on hospitals.
The NHS provider, which represents health organizations across the UK, said the Kovid-19 pressures were intensified, particularly in London and the south-east, where the increase in admissions over the past few days was “extremely worrying”.
Safer Cordy, deputy chief executive of NHS Providers, said that as of Wednesday the hospital in England had 22,713 Kovid-19 patients – an increase of over 27 per cent in seven days. “In the same period, the number of patients caring for Kovid-19 patients increased by 35 percent,” he said.
Matt Hancock, Britain’s health secretary, went on to suggest on Thursday that the vaccination program, which the government deems important for the naming of the epidemic, was falling behind schedule.
He said 944,539 people across the UK had received their first dose of the Kovid-19 vaccine. “The NHS has a clear vaccine delivery plan and today’s data shows once again how our magnificent NHS has grown into this huge task. . . Now that we have authorized a second vaccine, we can expect this number to increase rapidly in the coming months. ”
Although partial protection through the vaccine begins 12 days after the first job, Pfizer asserts that two doses with an efficacy of 95 percent are required to provide maximum protection against the disease. Crucially, it stated: “There is no data to demonstrate that safety after the first dose is maintained after 21 days.”
The drugmaker said the decision on alternative dosing regulations was in the hands of health officials and it committed to talk to regulators, but stressed that each recipient should be provided the maximum possible protection, “meaning the vaccine. Vaccination with two doses “.
The Medicines and Healthcare Products Regulatory Agency stated: “After an in-depth review of data by MHRA’s Kovid-19 Vaccine Benefit Risk Expert Working Group, it was decided to update the dosage interval recommendations for the BioNotech / Pfizer vaccine. This expert group concluded that vaccine efficacy would be maintained with an interval of more than 21 days. ”
Doctors in Britain expressed anger and concern over the switch, saying they would have to spend time canceling appointments for those who expected to receive their top-up doses within the next few days.
Helen Salisbury, a GP in Oxford, described the situation as “a shaggy” and calculated that it would take the network of practices to have 193 hours of staff time for refinancing appointments for her field staff.
She questioned the decisions and data modeling behind the decision. What does science say? We do not know. “
The British Medical Association said that doctors rebooking the appointments of thousands of elderly and vulnerable patients was “inappropriate and completely inappropriate, and practices that support existing appointments booked for the next few days” should be done”.
In his New Year message, the UK Prime Minister, Boris Johnson, praised the Oxford vaccine, saying that it “provides a new lease of life to people in this country and around the world”.
However, he warned of “a difficult struggle still to stay ahead of us for weeks and months, as we face a new version of the disease that requires a new vigil”.
Four questions about the UK’s Oxford / AstraZeneca vaccine rollout
Why is there a delay of six days between regulatory approval and
First vaccination with the Oxford / AZ vaccine?
Vaccines are to be distributed and stored according to conditions set by the UK drugs regulator, MHRA, which was not known until the announcement of approval on Wednesday.
What other factors are delaying the deployment of new vaccines?
Jonathan Van-Tam, Deputy Chief Medical Officer, said this week that “the only thing that’s going to slow us down is batches of vaccines being available”. This, he said, was “not only about manufacturing the vaccine”, but also about “filling and finishing” – the process of applying the vaccine and packaging it for distribution – which he said “worldwide Was a severely under-resourced “. A second factor that delays supply for patients is the regulatory requirement that each batch of vaccines is tested for safety and quality before being given to patients.
There will be a change in dosage and dose after another.
12 weeks speed talks?
The decision to increase the interval between doses, not only for the Oxford / AstraZeneca vaccine, but also for the BioNotech / Pfizer version, aims to protect more and more people. For those who have already found a measure of safety, there is no need to hold back half the supply to give another dose, all available doses can be used immediately. However, perhaps wary of the grand promises of previous epidemics that did not materialize, the government and the NHS would not be drawn on how many outcomes would be covered in a specific timeframe.
When the UK will be able to deliver on 2m people target
Week being vaccinated?
The government holds on to its promise that all over 50 people, and young people whose health is particularly weak, will be vaccinated by the end of March. Boris Johnson on Wednesday promised a “dose of tens of millions” from that point on. England’s NHS chief Simon Stevens has spoken of being covered by “late spring” in priority groups.