Pfizer criticized the UK’s decision to widen the gap between doses of its Covid-19 vaccine, saying that the “safety and efficacy” of the new regimen has not been evaluated as infections and hospitalizations have continued to increase across the UK .
The US pharmaceutical company’s rare intervention came amid growing controversy over the move, with general practitioners complaining that they were having to cancel appointments and reassuring anxious patients who had previously been told they needed the second dose to keep them safe .
“[Our] study . . . was designed to assess the vaccine’s safety and efficacy after a two-dose, 21-day schedule, ”said the company.
“The safety and efficacy of the vaccine have not been evaluated in different dosing schedules, as most 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 released on Wednesday, allow the second dose of the vaccine that Pfizer developed with BioNTech and the recently approved Oxford / AstraZeneca vaccine to be delivered in up to three months after the first.
The move aims to give a first dose of the vaccine to as many people as possible, in an attempt to contain the growing number of cases caused by a viral variant of the coronavirus that has been found to be much more infectious.
On Thursday, new evidence emerged of the toll the virus is causing in the UK, with a further 964 deaths announced and new signs of the strain in hospitals.
NHS Providers, which represents healthcare organizations across the UK, said pressures from Covid-19 were intensifying, especially in London and the south-east, where the increase in admissions in the past few days was “extremely worrying”.
Saffron Cordery, executive vice president of NHS Providers, said that as of Wednesday there were 22,713 Covid-19 patients in the hospital in England – an increase of more than 27 percent in seven days. “In the same period, the number of Covid-19 patients in intensive care beds increased by 35 percent,” he added.
UK health secretary Matt Hancock went on Thursday to counter suggestions that the vaccination program, which the government sees as vital to controlling the pandemic, was behind schedule.
He said 944,539 people across the UK received their first dose of the Covid-19 vaccine. “The NHS has a clear vaccine delivery plan and today’s numbers show once again how our fantastic NHS has achieved this huge task. . . Now that we have authorized a second vaccine, we can expect that number to increase rapidly in the coming months. ”
Matt Hancock said more than 940,000 people got their first Covid-19 vaccine © Jessica Taylor / UK Parliament
Although partial protection through the vaccine appears to begin 12 days after the first injection, Pfizer emphasized that two doses were necessary to provide maximum protection against the disease, with a 95 percent effectiveness number. Crucially, it said: “There is no data to show that protection after the first dose is maintained after 21 days.”
The pharmacist said that decisions on alternative dosing regimens are in the hands of health authorities and that she remains committed to talking to regulators, but stressed that each recipient should receive the maximum possible protection, “which means immunization 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 a complete review of the data by the Covid- Vaccine Risk and Benefit Specialist Working Group. 19 of the MHRA. This group of experts concluded that the vaccine’s effectiveness will be maintained with dosage intervals greater than 21 days. ”
UK doctors expressed anger and concern over the move, saying they had to waste time canceling appointments for people who expected to receive their supplement in the next few days.
Helen Salisbury, a GP in Oxford, described the situation as “a mess” and calculated that it would take the network of clinics that administer the vaccine in her area 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 appointments for tens of thousands of elderly and vulnerable patients was “irrational and totally unfair, and practices that honor existing appointments scheduled for the next few days should be supported.”
In his New Year’s message, Boris Johnson, Prime Minister of the United Kingdom, welcomed the Oxford vaccine, saying that “it literally offers a new life for people in this country and around the world”.
However, he warned of “a tough fight that we still have ahead for weeks and months, because we face a new variant of the disease that requires new surveillance”.
Four questions about the launch of the Oxford / AstraZeneca vaccine in the UK
Why is there a six-day delay between regulatory approval and the
first vaccinations with the Oxford / AZ vaccine?
Vaccines must be delivered and stored under conditions set by the UK drug regulator, MHRA, which were not known until the approval announcement on Wednesday.
What other factors are delaying the implementation of the new vaccine?
Jonathan Van-Tam, deputy medical director, said this week that “the only thing that will slow us down is the availability of lots of vaccines”. This, he said, was “not just about making vaccines”, but also about “filling and finishing” – the process of putting the vaccine in bottles and packaging it for distribution – which he said was “a critically short resource in Worldwide”. The second factor that delays delivery to patients is the regulatory requirement that each batch of vaccine be checked for safety and quality before it can be administered to patients.
Changing the dosage regimen to one dose and one second after
Do 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, more quickly. Without the need to retain half the supply to give a second dose to those who have already received a protective measure, all available doses can be used immediately. However, perhaps wary of past great pandemic promises that have not come to pass, the government and the NHS will not know how many more will be covered in a given period of time as a result.
When will the UK be able to meet the goal of 2 million people?
week getting vaccinated?
The government keeps the promise that all those over 50 and young people with particularly vulnerable health will be vaccinated by the end of March. Boris Johnson on Wednesday promised “tens of millions of doses” so far. Simon Stevens, head of the NHS in England, said that all priority groups will be covered by “late spring”.