Pfizer criticized the UK’s decision to extend the interval between Covid-19 vaccine doses, saying the “safety and effectiveness” of the new schedule has not been evaluated because infections and hospitalizations continue to soar across the UK.
The rare intervention of this American pharmaceutical company is a result of increasing controversy surrounding this move. Doctors complained that they had to cancel appointments and reassure patients who were anxious that they had been told that they needed a second dose. To ensure their safety.
“[Our] Learn. . . The vaccine is designed to assess the safety and effectiveness of the vaccine according to a two-dose schedule (21
“The safety and effectiveness of the vaccine have not been evaluated according to different dosing schedules because most trial participants received the second dose within the window specified by the study design.”
The new dosage guidelines have been approved by the Joint Committee on Vaccination and Immunization in the United Kingdom and announced on Wednesday, allowing the second dose of vaccine developed by Pfizer and BioNTech and the newly approved Oxford/AstraZeneca vaccine to be provided in three batches. One month later.
This change aims to provide the first dose of vaccine to as many people as possible in response to the spiraling increase in the number of cases caused by the virus mutation of the coronavirus that has been found to be more infectious.
Last Thursday, there was new evidence of the damage caused by the virus in the UK. Another 964 people died. The hospital also showed signs of a new strain.
NHS Providers, representing health organizations across the UK, said that the pressure on Covid-19 is increasing, especially in London and the southeast, where the surge in hospital admissions in the past few days is “extremely worrying”.
NHS Providers vice president Saffron Cordery said that as of Wednesday, 22,713 Covid-19 patients were hospitalized in England, an increase of more than 27% in seven days. She added: “During the same period, the number of Covid-19 patients in intensive care beds increased by 35%.”
British Health Minister Matt Hancock on Thursday tried to disprove recommendations that the government believes that the vaccination plan that is essential to contain the pandemic is behind schedule.
He said that 9,44539 people across the UK had been vaccinated against Covid-19 for the first time. “The NHS has a clear vaccine delivery plan. Today’s data shows once again how our excellent NHS accomplishes this difficult task… Now that we have approved the second vaccine, we can expect this number in the next few months. Will increase rapidly.”
Although partial protection by the vaccine seems to begin as early as 12 days after the first jab, Pfizer emphasizes that it takes two doses to prevent the disease to the greatest extent, and its efficacy is 95%. Crucially, it said: “There is no data to show that protection can be obtained after the first dose after 21 days.”
The drugmaker said that the decision on alternative dosing regimens is in the hands of the health authorities and is still committed to dialogue with regulatory agencies, but it emphasizes that each recipient should be provided with the greatest possible protection, “This means using two doses of vaccine Immunization”.
The drug and healthcare product regulator stated: “After the MHRA’s Covid-19 Vaccine Benefit Risk Expert Working Group thoroughly reviewed the data, it decided to update the BioNTech/Pfizer vaccine dose interval recommendations. The expert group concluded that the dosing interval The vaccine will remain effective for more than 21 days.”
Doctors in the UK expressed anger and concern about this change, saying they had to take the time to cancel appointments for those who expected to receive supplemental doses in the next few days.
Helen Salisbury, a general practitioner at the University of Oxford, described the situation as “a mess” and calculated that it would require 193 hours of work in the area to use a network of practices for managing vaccines to reschedule appointment.
She questioned the judgment and data modeling behind the decision. “What does science say? We don’t know.”
The British Medical Association stated that requiring doctors to reschedule appointments for thousands of elderly and disadvantaged patients “is unreasonable and totally unfair, and should support respect for existing appointments in the coming days.”
British Prime Minister Boris Johnson praised the Oxford vaccine in his New Year’s message, saying that it “really provides new lives for people in this country and around the world.”
However, he warned: “Because we are faced with new variants of the disease and require new vigilance, we still need weeks and months of hard work.”
Four questions on the promotion of Oxford/AstraZeneca vaccines in the UK
Why is there a six-day delay before regulatory approval and approval
Oxford/AZ vaccine for the first time?
The vaccine must be shipped and stored in accordance with the conditions set by the British drug regulatory agency MHRA, and it was not known until after the approval announcement on Wednesday.
What other factors hinder the deployment of new vaccines?
Deputy Chief Medical Officer Jonathan Van-Tam said this week, “The only thing that slows us down is the advent of batches of vaccines.” He said that this is not only “the production of vaccines,” but it also involves “filling and finishing” (the process of putting vaccines in vials and packaging for distribution), which he said is “a critical shortage of resources worldwide.” The second factor in delaying the supply of patients is the regulatory requirement that each batch of vaccine must be checked for safety and quality before it is provided to patients.
After the medication regimen is changed to one dose for one second
Speed up in 12 weeks?
The decision to increase the dose interval is not only for the Oxford/AstraZeneca vaccine, but also for the BioNTech/Pfizer version, with the goal of protecting more people faster. There is no need to reserve half of the supply to provide a second dose to people who have already received protective measures, and all available doses can be used immediately. However, perhaps due to the previously unfulfilled pandemic promises that have caused vigilance, the government and the NHS will not be involved in a specific time frame.
When will the UK achieve its goal of 2 million people?
Vaccination in a week?
The government kept its promise to vaccinate all people over the age of 50 and young people with particularly vulnerable health conditions by the end of March. Boris Johnson promised on Wednesday that it would reach “tens of millions of doses.” Simon Stevens, the head of England’s National Health Service (NHS), talked about everyone in the priority groups covered by the “late spring”.