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Pfizer and its partner BioNTech plan to offer their Covid-19 vaccine to any clinical trial volunteer who received a placebo before March 1, several months earlier than initially planned.
The move represents the conclusion of a complex and public kabuki dance between the Food and Drug Administration, Pfizer and Voluntary Vaccines, as well as with Moderna, which has developed its own Covid-19 vaccine. The FDA and its advisers pushed for volunteers to stay on placebo as long as possible in order to collect more data on the safety and effectiveness of the vaccines, while the companies argued that volunteers should receive the vaccines. earlier for both ethical and practical reasons.
Among some trial participants, the issue had become thorny, with many protesting further delays in passionate posts on social media and letters to media organizations, including STAT.
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Michael Tovar, a volunteer who had campaigned publicly for Pfizer to deliver the vaccine faster to clinical trial participants of 44,000 people, thanked the company and its CEO on Twitter.
“Thank you for listening and changing your study protocol to allow rapid vaccination of your placebo arm,” Tovar wrote. “You made this new year so much brighter for the 22,000 placebo volunteers who mobilized for this vaccine.”
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Pfizer and BioNTech disclosed the decision on a website for clinical trial participants and in a letter, obtained by STAT, that was sent to researchers conducting the clinical trial.
The letter to the researchers said they were also asking participants to take additional Covid testing, which will be performed by home clinical trial volunteers, to help understand whether the vaccine, which reduces symptomatic infections by 95%, prevents also asymptomatic infections. The answer to this question is important; currently, there is no way of knowing whether people who have received the vaccine can still pass it on to others.
In medicine, the most reliable answers about treatments and preventatives come from double-blind, placebo-controlled trials. This means that patients are randomly assigned to receive either the treatment, in this case a vaccine, or a placebo. Neither they nor their doctor know what they received. In many trials, such as those on cancer, it is simply assumed that patients who received a placebo will receive the treatment after the study is completed. This stage is known as crossing over.
But the question of how the placebo crossover should be handled during a pandemic has been left open by both the FDA and the U.S. government’s Operation Warp Speed efforts, which sped up vaccine development, when studies began in July. The consent forms given to volunteers, obtained by STAT, did not mention when or if those who received the placebo would receive the vaccine in two doses.
At a Dec. 10 meeting of an advisory committee regarding the emergency use authorization for the Pfizer / BioNTech vaccine, the FDA discussed how the placebo crossover should be managed. In this session, Steven Goodman, associate dean of clinical and translational research at Stanford University School of Medicine, argued that there was no ethical reason why the volunteers in the placebo group should deserve to receive the vaccine before the general public.
Goodman presented a complicated scheme, known as a double-blind crossover study, in which any volunteers who wanted to be sure they received the vaccine would be offered two more injections. Those who had received the vaccine would be offered a placebo, and those who had received the placebo would be offered the vaccine.
William Gruber, one of Pfizer’s top vaccine executives, argued the plan was unworkable. Essentially, you would have to do a lot of the study a second time.
Instead, Pfizer made a plan in which volunteers who wanted the vaccine could receive it when they were eligible to receive the vaccine in their area. Healthcare workers or residents of long-term care facilities, who were already eligible for vaccination, would receive the vaccine immediately.
“If you are not a healthcare worker or resident in a long-term care facility (or any other group added in the future), we will discuss an option to switch from the placebo group to the vaccine during your fourth study visit, approximately six months after initially receiving your second injection, ”states a letter sent to participants at the end of December. “We respectfully ask you to wait for Study Visit # 4 to discuss the vaccine transition option.”
This complex process was moving quickly, as many of the study participants were healthcare providers. According to the letter obtained by STAT, 2,000 volunteers who received a placebo have already received their first dose of Pfizer vaccine. But it was clear that others would have to wait.
But then, on December 17, the FDA held another advisory meeting, this time for Moderna’s vaccine, which had been developed more closely with Operation Warp Speed. Once again, Goodman made his presentation. A researcher representing Moderna argued, like Pfizer, that his idea was unworkable and presented a plan to administer the vaccine to volunteers receiving a placebo much faster than Pfizer. They would not have to wait until they are eligible to get vaccinated outside of the trial.
FDA advisers spent considerable time comparing Goodman’s plan to Moderna’s, ultimately agreeing that Goodman’s was unworkable. But they spent little time comparing Pfizer’s plan, which delayed the vaccine for longer, to Moderna’s.
This left Pfizer at a standstill as more and more volunteers protested publicly that they should be offered the vaccine if they were given a placebo.
Alan S. Goldsmith, a retired doctor in Florida who volunteered for the Pfizer trial, told STAT that he and his wife, who had also volunteered for the study, did not expect not even get the vaccine if they were in the placebo group. They just wanted to know if they had ever received the vaccine.
“What this would allow us to do is know our immunization status, which could give a little more freedom to do things like visit our grandchildren,” he wrote.
On December 23, Moncef Slaoui, in charge of Operation Warp Speed, told reporters that he believed that volunteers who received a placebo should receive the vaccine immediately, which contradicts the FDA. He also called the Pfizer plan intellectually elegant but unworkable, saying that with different vaccination requirements in all 50 states, it would be difficult to administer.
Pfizer was apparently already working on making its crossover plan more like Moderna’s. New language published on its website for trial participants on New Years Eve, said vaccine doses had been secured and BioNTech aimed to ensure that all participants who received placebo had the opportunity to get their first dose of vaccine before on March 1, if they wish.
A letter from Nicholas Kitchin, senior director of Pfizer’s vaccine research and clinical development group, set a cheerful tone for a clinical paper.
“We recognize that the participants in our clinical trials are selfless volunteers who have made the important choice to make a difference and fight this pandemic,” Kitchin wrote.
“While the study continues to be blind to answer important public health questions such as the persistence of protection, long-term safety and protection against asymptomatic infections, we are committed to ensuring that Participants in our trial are recognized for their contributions and that wishing placebo recipients may receive BNT162b2 as part of the study. “
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