Faced with the slow launch of vaccines, surging Coronavirus disease Deaths, and the threat of a dangerous variant of the virus spreading across the country, some scientists have called for an urgent reduction of vaccine doses, or halving them so that as many people as possible can be vaccinated as soon as possible. But other scientists and U.S. regulatory agencies have postponed the plan, fearing that such plan changes may have disastrous consequences.
The rapid emergence of disagreements caused experts to resent the experts, just as the first Americans to receive the COVID-19 vaccine began to receive the vaccine. Their second shot.
Given that clinical trials have been established to test the two-dose schedule, no one can determine the effectiveness or duration of a single dose. To make matters worse, there are concerns that giving people partial protection may increase their chances of harm. The virus continues to evolve to resist The role of vaccines.
However, some scientists said that this situation still requires special measures. “When it comes to COVID-19, we have been slapped in the mouth again and again. Now is the time to change the plan,” wrote Ashish Jha of Brown University and Bob Wachter of the University of California, San Francisco. Washington Post editorial On Sunday, it is called for the vaccine to be given to as many people as possible, and to postpone the second injection until more doses are given.
The Director of the US Food and Drug Administration Stephen Hahn and Peter Marks, director of the Institutional Vaccine Center, rejected any changes to the current plan. statement The news released on Monday night said: “At present, it is implied that changes to the dose or schedule of these vaccines authorized by the FDA are too early and cannot be firmly rooted in the existing evidence.”
Two vaccinesIt is made by Pfizer and the other is made by Moderna. It was approved for emergency use in the United States last month. Large-scale clinical trials have found that when used separately for three or four weeks, the two doses have a high protective effect against COVID-19 and can resist COVID-19. The FDA’s Hahn and Marks stated that the observed signs of diminished COVID-19 diagnoses among study participants between the two doses do not justify a change in the schedule. The American Academy of Infectious Diseases supported the FDA’s statement on Tuesday, saying the timetable changes “Premature and potential harm. “
“For some reason, the clinical trial was designed to give two doses on a schedule. This is the data we have.” said Joel Ernst, a vaccine expert at the University of California, San Francisco. “I think the agency [FDA] An operational reality is being injected into interesting and useful scientific discussions, and we should discuss this as well. “
The United Kingdom Joint Committee on Vaccination and Immunization (JCVI) overturned last week’s debate, Extension of time It takes up to three months to take a second dose of Pfizer vaccine at a time. 1 in 30 London residents It is believed to be infected with the coronavirus. Most strikingly, the committee recommends that in an emergency, if the first shot of the vaccine is not available, or if you don’t know which vaccine to get first, you can use a second dose of a different vaccine.British Society of Immunology Reluctantly supports time changes, There is evidence that, in this case, the highly transmissible variant of the pandemic coronavirus has caused an alarming increase.
Natalie Dean, a biostatistician at the University of Florida, said: “The situation in the UK reflects the emergency situation there.” “If there is no transparent process of the FDA and CDC that first leads to vaccine authorization, I don’t see the United States will do this change.”
This B.1.1.7 Coronavirus variants, First discovered in the UK, because the vaccine is easier to spread, complicating the calculation of how many people need to be vaccinated.Dean said that it has now been broadcast in more than 30 countries, “In the United States, we have to assume that this variant may be all over.” Although so far only in Four states, Poor genome monitoring In the U.S. it may mean that it is more common than we currently know. Dean said that even if it is popular, the current mathematical methods should not be changed by sticking to the current vaccine schedule.
She added that in the next few months, we will better understand the antibodies and immune system cells that can provide protection from infection from vaccines. “Once these protective associations are in place, then we can be more confident about any changes in dosage.”
Both Pfizer and Moderna sent BuzzFeed news statements on Monday to support the FDA-authorized second dosing schedule. “While the decision on alternative dosage regimens rests with the health authorities, Pfizer believes that it is essential to monitor any alternative schedules that have been implemented and to ensure maximum protection for each recipient. This means Two doses of vaccine will be used for immunization,” Pfizer stated.World Health Organization Panel of Experts on Tuesday Support Pfizer’s timeline, But under special circumstances, the second dose can be given six weeks later.
At the same time, in the United States, Moncef Slaoui, the chief scientist of Operation Twisting, proposed on Sunday to give people two Half dose of Moderna vaccine supply. The National Institutes of Health confirmed on Tuesday that it is studying a half-dose treatment regimen. New York Times report.Sloy suggested increasing the supply, but to some experts’ surprise, his $18 billion in vaccines Private-public partnerships widely acclaimed for quickly advancing vaccine development are under fire for failing to fulfill their promises Provide 20 million photos By the end of this year.They only delivered 17 million and have executed the shooting Over 5 million people As of Wednesday.
Some public health figures such as Jha and Wachter called on the United States to join the United Kingdom to extend the time for the second shot. But in Monday night’s statement, the FDA recommended that this argument overestimated the certainty of effectiveness after an injection.
Ernst said: “We have to realize that every vaccine is different, and we don’t know everything.” “If we knew everything, we would get the HIV vaccine 30 years ago.”
For Marc Lipsitch, an epidemiological modelling expert at Harvard University’s TH Chan School of Public Health, the FDA’s status reflects its role as the goalkeeper of new treatments in the United States.
The FDA is a regulatory agency. Broadly speaking, they are not public health agencies-their job is to ensure that what we inject into ourselves and what we take as pills and supplements and everything they advertise. In a narrow sense, they are correct. “He said at a briefing on Tuesday.
Lipsitch said: “This is a very interesting case. Regulators believe that science, but broadly speaking, the science of public health may be different.”
Many experts have another major concern about the proposal to change the U.S. medication schedule, that states seem to be unable to inject the doses that have already been shipped. In general, the speed of vaccine launch is slower than advertised. There is a big difference from state to state.
Angela Rasmussen, a virologist at the Georgetown Center for Global Health Science and Security, said: “This is basically hitting the ball on the 1-yard line.” “Why are we talking about fundamentally repairing the line.” It’s an effective dosing regimen, and when I can’t get the vaccine supply that people know-do I get a limited supply of vaccine?”
Vaccine forecasts have been steadily weakened in this way for several months, starting from OWS to the downgrade of the initially promised 300 million doses in January. Quietly abandoned in August.
George Benjamin, executive director of the American Public Health Association, said: “According to their own predictions, they are behind.” “The truth of the problem is that we have been hoping for some elimination. These are complex vaccines. But all of this shows that we need Manage shots at a faster speed.”
With the increase of billions of dollars Recently passed spending billBenjamin added that, as well as the future actions called for by the incoming Biden administration, the United States needs to switch to 2 million to 3 million vaccine injections per day in order to reverse the trend of this epidemic. The point of contention is the dosing schedule, rather than recruiting retired doctors, dentists and anyone else who can boldly shoot the doses that appear on the shelf, which is impractical.
“What is the goal? The goal is to stop this pandemic. We need to use all the necessary tools to stop this pandemic.”
Improper gains and losses of the U.S. Senate Vaccine launch funding Jim Blumanstock of the National and Territorial Health Officials’ Association told BuzzFeed News that until last week, as well as the arrival of storms and holidays, states had been dealing with vaccine launches in medical institutions that had already handled a large number of COVID-19 cases. Hinder. He said: “In the final analysis, our broken health care system makes this more difficult.” “The federal government needs to play a bigger role.”
The first stage of vaccination in large medical centers and nursing homes is not where most vaccines should be given in a few months.On Tuesday night, the Trump administration said it was accelerating a project aimed at Start getting the vaccine in the pharmacy. The final plan is to follow the flu shot and provide vaccination by the doctor’s office, pediatrician and pharmacy.So far this season, some 71 million flu vaccines Within 15 weeks of starting with a small number of people, American adults have been photographed, and more than 8 million photos have been taken in a few weeks. In the fall, Amanda Cohn of the Centers for Disease Control and Prevention warned members of its vaccine advisory group: The first six weeks Before the increase in production, the delivery of COVID-19 vaccine will also be marked by a small number of injections.
Blumenstock said: “If we look again in three weeks, the discussion about vaccines may be different.” OWS’ Slaoui has compared the COVID-19 vaccination campaign with the annual flu vaccine and expanded it. Three to four times.
But this sounds optimistic, Walter Orenstein, the former head of the National Immunization Program at Emory University, told BuzzFeed News. He said that people know that the vaccination they will get is much easier than the COVID-19 vaccine. The flu vaccine is just a shot. There are no changing cold chain requirements, more consent requirements and enhanced plans, just like the COVID-19 vaccine we are currently using. Orenstein said: “We have never encountered a situation like this before, even compared to the hastily introduced a similar situation.” 2009 H1N1 flu vaccine. The vaccine is not given to yourself. The biggest problem here will be to get people to work together. “
Michelle Dryger, a health communications expert at the University of Manitoba in Canada, said that the real threat of insufficient injections and escalation of vaccine use plans is that public trust in vaccines may decline. In this year’s focus group, she was very worried about taking the new vaccine. Canada’s deployment is similar to that of the United States. The federal government distributes doses to provinces, and each province decides how to distribute their shots.
She said: “I think the FDA’s statement is very clear and effective. This is a good public health message.” “I think at the public level, we need to understand that the agency is doing due diligence.”
Stephanie M. Lee provided coverage for this story.
January 7, 2021, 17:26 PM
correct: Angela Rasmussen at the Georgetown Center for Global Health Science and Safety. An earlier version of the post incorrectly stated her institution.