US recommends third COVID-19 vaccine for seniors
The Food and Drug Administration (FDA) Advisory Panel Unanimously Endorses the Pfizer (PFE) / BioNTech (BNTX) Third Dose recommendation for Americans 65 and older and those at high risk of contracting a severe case of COVID -19. Among them are specialists working at the forefront of the fight against this disease. Writes about it Yahoo!
A meeting of the Centers for Disease Control and Prevention (CDC) advisory group, scheduled for next week, will take a closer look at who will qualify for the additional dose.
Dr. Lena Wen, visiting professor at the Milken Institute School of Public Health at George Washington University, said the voting had brought about a balance among the group.
The vote came after a heated debate over the need for revaccinations or additional injections by both mRNA vaccine companies, Pfizer and Moderna.
“This is a smart middle ground solution that gives doctors and patients the discretion to decide who is at high risk. This level of individual decision-making is key, ”says Wen.
“Of course, it's true that unvaccinated people are the main problem when it comes to the spread of COVID-19, but that shouldn't mean that vaccinated people don't deserve better protection with an extra dose if they so choose,” she explained.
Dr. Peter Marks, the FDA's chief vaccine expert, addressed recent controversies in his opening remarks.
“We know there may be differing opinions about the interpretation of the data regarding the potential need for additional doses. Therefore, we strongly recommend that you voice and discuss all points of view regarding data that are complex and constantly changing, ”said Marks.
According to him, the meeting was devoted to the analysis of what is happening in the world. Its main goal is to slow the spread of COVID-19, which kills nearly 2000 Americans every day. Presentations included data from the UK and Israel.
Among other things, Marks noted that the FDA is not obligated to follow the recommendations of the commission.
The meeting precedes the September 20 additional dose start date, announced last month by the White House COVID-19 response team. True, data from the US Centers for Disease Control and Prevention (CDC) show that some Americans are already receiving third doses. Last month, the CDC recommended them for immunocompromised people.
At a response team briefing, US Surgeon General Dr. Vivek Murthy said the administration is already communicating with pharmacies, nursing homes and officials to help roll out additional vaccinations.
The question of whether the average American needs an extra dose has been a hot topic for several weeks.
Measuring antibody levels after vaccination, which tend to decline, compared to using memory cells that can remember how to fight the virus (which is typical of vaccination), has been at the center of the debate in the scientific community.
A Pfizer spokesman admitted that "this is a much more complex situation" than just antibody titers.
Those who opposed third doses believed these doses were best used in countries with low vaccination rates.
Marx also did not shy away from this issue and noted that the committee should weigh only the data and the need for vaccinations, and not the global fairness of vaccine distribution or operational problems when deploying a revaccination campaign in the United States.
The decision relied heavily on data from Israel and the UK, which raised concerns.
Dr. Angela Rasmussen, Research Fellow at the Vaccines and Infectious Diseases Organization at the University of Saskatchewan, said there are some very important differences in vaccination campaigns, demographics and other key comparisons between the three countries.
“You can draw some general conclusions based on data from another country. But comparing small details is difficult, ”said Rasmussen.
According to Katrin Jansen, senior vice president and head of vaccine research and development at Pfizer, the company believes that additional doses are an important tool in the fight against the spread of the virus.
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“We thank the committee for its thoughtful analysis of the data and will work with the FDA to answer its questions as we continue to believe in the benefits of the extra dose for the wider population,” Jansen said.
Lack of data
A new CDC report found Moderna vaccine continues to provide the best hospitalization protection compared to Pfizer and Johnson & Johnson (JNJ) vaccines.
The executives of both mRNA companies have previously stated that additional doses are inevitable. But when these doses are needed - annually or just as a third shot - remains unknown.
This was voiced by Moderna President Stephen Hoge in a recent interview.
“We really don't know if the third shot will be final or if more will be needed,” he said.
Pfizer CEO Albert Burla wrote an open letter in support of additional doses based on data from the company's clinical trials and data from Israel.
But the FDA has previously warned that some of the studies from Israel have not been verified by a regulatory agency.
Burla also drew attention to concerns about equitable distribution of vaccines around the world.
“I believe that the introduction of additional doses cannot change the number of doses that each country receives. None of the commitments that Pfizer has already made to the country should change if the doses are approved, ”Burla said.
Meanwhile, according to some media reports, the US is preparing to purchase an additional 500 million doses of Pfizer vaccine for donations around the world.
Discussion of the data was complicated by the fact that the United States and Israel have different definitions of the severe illness caused by COVID-19. However, the data were mostly for mild infections.
According to Dr. Marion Gruber, one of the FDA's leading vaccine reviewers, vaccines in the United States are effective "in protecting against serious illness, although some evidence suggests that the effectiveness is declining."
Data from Israel presented at the FDA meeting showed decreased protection against infection, but protection against hospitalization and serious illness remains strong. This was the reason critics of the additional doses were opposed.
Moderna's Hoge noted that additional doses will eventually be required to help counter the expected surge in COVID-19 in the late fall and winter.
Pfizer's data showed that efficacy against infection began to decline after about 6 months. For comparison: Moderna, judging by its data, is valid for about 8 months.
FDA scientists said most of the data came from outside the United States, mainly because the country is not capable of collecting data the way Israel did.
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