When Pfizer CEO Albert Bourla said on March 13 that all Americans needed a second booster shot, many coronavirus experts saw it as selfish remarks with no scientific merit. It also raised doubts about the country’s goals in fighting the coronavirus.
Decisions about the frequency and scope of COVID-19 vaccinations are part science, part policy, and part politics. Ultimately, it depends on the goals of vaccination, and it was clear at the time that neither vaccine nor other measures could completely stop the virus from spreading.
On March 15, Pfizer made a more limited request to the FDA, seeking authorization for a second booster only for people 65 and older. Advisors from the FDA and the Centers for Disease Control and Prevention may approve a fourth shot for people in that age group, who are most likely to be hospitalized or die from the virus. Pfizer’s competitor Moderna Also submitted on March 17 A second booster shot was given, although its use was extended to all adults.
Vaccines protect against covid infection Usually weakens within a few months in all age groups. But experts disagree on whether frequent boosters, especially for young people, can make a difference. Two or three vaccinations can protect most people from severe disease — but relatively little has been done to prevent infection, which is usually mild or asymptomatic, after three or four months.
Statements like Burra’s have created public pressure on a fourth dose of a vaccine, which could force the Biden administration to act before government experts have time to evaluate the evidence, said John Moore, a professor of microbiology and immunology at Weill Cornell Medicine. .
it seems to be based on An Israeli study that has not been peer-reviewed They examined patients just weeks after receiving the fourth dose of the vaccine.Limited scope of data raises questions about duration of protection, says Dr. Phil ClausFormer Deputy Director of the FDA Center for Biologics. Before resigning last fall, Krause helped lead the agency’s Covid-19 vaccine review.
Throughout the pandemic, repeated public statements by pharma executives — widely disseminated through the media, often without supporting data — have put pressure on politicians and their scientific advisers to act.
last summer, Bourla announces possible demand For the initial booster in April 2021, then in August, Joe Biden Presidential Promise The first booster shot will be available to all adults starting next month. “It created an expectation that everyone was going to get a delicious piece of chocolate cake,” Moore said. “Who wants to be a ‘cake Nazi’ and say, ‘No cake for you?!'”
Although FDA and CDC panels and some federal scientists were hesitant to recommend the first booster for young adults, the agencies overturned their recommendations and approved the booster for everyone 12 and older. This remains a pain point for many immunologists and infectious disease specialists.
“The last thing we need is for a company CEO to say in March that’s what you need in December because ‘we know,'” Moore said. “How do you know?” CEO announcements are often made before the scientific evidence supporting the claims is publicly released, meaning scientists haven’t had time to assess their validity.
The desire to respond to growing signs of infection is understandable, but may be futile in the face of a virus that appears to infect even well-vaccinated people. If we continue to track the virus with boosters, “we’ll make the pharmaceutical companies very happy because our antibodies drop every four months,” said Dr. Paul Offett, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.
But whether these levels are a good measure of protection — especially against severe disease, and in which groups — is an open question. The answer is important because, as with all vaccines, there is a small risk of adverse reactions with each shot.
There is some disagreement among experts on how well the coronavirus vaccine has so far prevented serious disease in healthy young adults, and whether and how often it should be boosted.
although A recent CDC study showed an increased risk of hospitalization in people aged 18 to 49 months after the second and third doses of the vaccine, but the categories of data in the study were not granular enough to show whether many people with severe disease had comorbidities such as chronic disease disease or obesity, Offit said.
But others argue that there is enough evidence that annual vaccinations, perhaps combined with flu vaccinations, would be the best solution. “Given the safety and efficacy of vaccines, I think it might actually make sense for people to get boosters, and it’s most convenient to do it once a year,” said Dr. Otto Yang, an infectious disease expert at UCLA. He said that if the new coronavirus is seasonal Sexually, peaking in winter, vaccination in the fall will provide decent protection.
“We definitely need another booster. We just don’t know when or which variant to target,” said Dr. Daniel Douek, head of the Division of Human Immunology at the National Institute of Allergy and Infectious Diseases.
The coronavirus, which causes about one-third of the common cold, appears to be infected about once a year on average, said Stanley Perlman, a coronavirus expert at the University of Iowa. A vaccine will never prevent all of these infections, Offit said, but the federal approach has largely acted as if it were feasible.
“Two years from now, we’re treating this virus like smallpox, quarantining anyone with mild illness, even asymptomatic people,” he said. “That’s going to have to change. Because whether it’s vaccination or natural infection , neither protects you from mild disease for an extended period of time.”
Dr. Luciana Borio, a former FDA and National Security Council official who is now a senior fellow for global health at the National Security Council, said it’s important for U.S. health officials to clearly understand the goals of the vaccination program and share it with the public. Diplomatic relations. “We need people to understand that protection against all diseases is not durable, rather than thinking that vaccines don’t work.”
“The goal is not to stop transmission, but to protect vulnerable populations,” said Dr. Norman Hearst, a family physician and public health researcher at the University of California, San Francisco.
In the absence of a perfect vaccine, how we protect vulnerable populations remains a conundrum. Borio believes that we need systems to quickly detect the elderly and immunocompromised people for COVID-19 and treat them quickly if they test positive.
But that’s easier said than done, Hurst said, because people rarely seek medical help for upper respiratory illness until the disease progresses to the point where antiviral drugs can’t help. Antiviral drugs usually work best, sometimes only within a few days of symptoms appearing.
Right now, all the debate about the second booster is moot, says John Wherry, chair of the Department of Systems Pharmacology and Translational Therapeutics at the University of Pennsylvania. Unless Congress changes itself and decides to give the government more money to fight the coronavirus, there won’t be any free vaccines or free coronavirus treatments available to the public next fall.
“We have a serious budget problem and we’re not out of the woods yet,” Wherry said. Coronavirus numbers have spiked again in Europe, and virus concentrations in wastewater are starting to double in some parts of the U.S., suggesting easing of coronavirus restrictions could lead to spread among uninfected people during the omicron wave in December and January .
Offit, a vaccine inventor and longtime advocate of vaccination, cautioned against relying too heavily on covid boosters for answers.
“If we had another variant like omicron that could sweep through people who got two or three doses, what would our response be?” he asked. “We’re going to take this and say, ‘Okay, calm down?'”
Kaiser Health News (KHN) is a national health policy news service.This is an editorially independent show Henry J. Kaiser Family Foundation Not affiliated with Kaiser Permanente.
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