As the coronavirus turns into a stubborn and unpredictable part of daily life, scientists and federal health officials are coming up with a new strategy for vaccinating Americans: a vaccination campaign this autumn, possibly with a dose that has been subtly tuned to combat the expected version of the virus. To be in circulation
The plan would borrow heavily from the playbook to distribute annual flu shots and could become a template to arm Americans against the coronavirus in the coming years.
But some experts question how well the push for a renewal vaccine would be accepted by epidemic-weary populations, that the doses could be expelled quickly enough to reach those who need them most – and whether most Americans need extra shots at all.
On June 28, scientific advisers from the Food and Drug Administration will meet in the United States to identify the coronavirus variant as temperatures cool. This should give manufacturers time to decide whether to revise the combination of vaccines and increase production, hopefully enough to churn out a few million doses by October.
Scientific advisers to the FDA say they would be more inclined to switch to a new version of the vaccine if existing ones are no longer effective and a modified version proves to be better.
The idea is that eligible Americans will be asked to be vaccinated against coronavirus and flu at the same time this fall, and in the same place: drugstore, doctor’s office, walk-in clinic, and the like. Some important details – such as who will qualify – will be picked up at a meeting of scientific advisers from the FDA and the Centers for Disease Control and Prevention next month.
The plan will mark the departure from the current sequential approval of booster shots for different ages. But flaws in the annual approach have become apparent to flu researchers over the years.
Scientists and federal health officials usually decide to make the flu vaccine in the spring, six months before the flu season. They speculate that which version of the flu virus will reach the United States, among other reasons, is already seeing what is happening in the Southern Hemisphere.
But over the years, “when the vaccine is made, the strains change, and then you may not have a good match,” said Dr. Offer Levy, director of the Boston Children’s Hospital’s Perfect Vaccine Program and an adviser to the FDA. , Said.
Candidates for the fall covid shot include a booster designed for Omicron, a strange new incarnation of the coronavirus, and so on. Dr Paul Burton, the company’s chief medical officer, said Moderna’s lead booster candidates each contained 25 micrograms of its original vaccine and one made for Omicron.
Pfizer is also testing an Omicron-specific vaccine, but according to company spokeswoman Jerica Pitts, it will not make a decision on its fall candidate until June.
Even if the vaccine does not match perfectly, some protection against any new form should be given in the fall to increase immunity, as does the flu vaccine.
The number of Americans choosing to receive a booster dose has decreased with each new proposed shot. Ninety percent of American adults received at least one dose of the covid vaccine, 76 percent received a second dose, and only 50 percent received a third dose.
Dr. Matthew Daly, a senior investigator in Colorado at Kaiser Permanente, head of the CDC’s Vaccine Working Group, said in a statement: Interview
That concern was also expressed at a committee meeting last month by Dr. Beth Bell, director of the National Center for Emerging and Zoonotic Infectious Diseases. Further, another vaccine could expand the nationwide campaign supply, and expel pharmacists, providers and public health workers, some advisers have warned.
And experts worry that the pressure to take extra doses this fall, while reducing the risk of serious illness and death for most Americans, could reduce the combined desire for a new alternative surface and the general public’s subsequent vaccination. It is
Repeated immunizations can even dull the effectiveness of the vaccine. For example, those who are vaccinated against the flu in one year develop stronger immunity than those who are vaccinated in two consecutive years, according to Florian Kramer, an immunologist at the Icon School of Medicine in Mount Sinai, New York.
Despite the concerns, federal officials are preparing for the fall campaign. The easiest way to convince Americans to stand in line for the vaccine is to combine the covid vaccine with the flu each year, says Peter Marks, director of the FDA’s Center for Biological Evolution and Research.
“It saves people time,” said Dr. Marx. “And that could mean that more people get both vaccines, which would be a good thing.”
Agency scientists are actively debating with the World Health Organization, the National Institutes of Health and vaccine manufacturers about the best formulation of the fall vaccine, Dr. Marks said.
The FDA favors offering a fairly similar formulation of Pfizer-Biotech and modern vaccines to avoid confusion. Otherwise, “I’m concerned that it could actually cripple a vaccine campaign, when the most important thing is that people are encouraged at all,” said Dr. Marks.
If the flu vaccine is any indication, however, many Americans will skip another cowardly shot. The Omicron variant has made it clear that preventing all infections is an unattainable goal, and many consider themselves at low risk of serious illness or death.
Nevertheless, Dr. Marx noted that the goal of the Influenza Campaign is to prevent loss of productivity, not just treatment outcomes.
Prior to the arrival of the Omicron variant, administration officials said that the Covid vaccines were intended to prevent all notable infections, but they moved away from that position.
Although Covid vaccines have reduced the prevalence of previous variants by up to 70 percent, “this is clearly not the case with Omicron,” he said. “It would be nice to have something that did a good job.”
Some experts say that instead of another round of injections, the best candidate to limit the infection would be a nasal spray that covers the nose and throat with antibodies to prevent the virus from entering. However, those sprays will not be available in the United States for at least two or three years.
Until the Omicron was approached, FDA scientists were so excited about the mRNA vaccine that they did not consider it an alternative booster, Dr. Marks added: “In the light we are temporarily blinded.”
However, reducing the number of infections whenever possible is “certainly a very important secondary goal,” said Dr. Sarah Oliver, who represents the CDC of the Covid-19 vaccine working group.
In addition to reducing the spread of the virus and social disruption, he said, reducing the risk of infection should be reduced in the case of long-covid, the star of symptoms that can last for several months, he said.
The new plan could rekindle some lasting tensions. Car vaccines should be recommended, and for whom, these agencies have been confused for months.
In general, the FDA’s scientific advisers review the safety and efficacy of vaccines and recommend approvals or approvals. Experts who advise the CDC on who should be vaccinated and when to issue guidelines.
During epidemics, the lines between the White House, the FDA and the CDC have often become blurred. “At the moment, one of the challenges is that we have a lot of voices who are talking about immunization policy, and historically we have only had one voice,” said Dr. Daly.
When the FDA approved a second booster, for example, it did so only for adults 50 years of age or older – a difference that would normally have been obtained from CDC vaccine advisers.
The CDC also makes a subtle difference that is lost on many Americans: it recommends that adults over the age of 50 get a booster if they want to, they shouldn’t. But the White House’s new coveted jar, Dr Ashish Jha, backed the second booster shot.
“It’s not entirely clear that the White House is in a position to recommend a vaccine, but he said he did,” said Dr. Camille Cotton, an infectious disease specialist and scientific adviser at Massachusetts General Hospital. CDC said. Dr. Jha.
It is unknown at this time what he will do after leaving the post. Congress’s stalemate over the Covid-19 fund threatens the government’s ability to purchase and supply vaccines to those most in need.
“Without urgent additional funding, we are unable to secure adequate booster shots for every American who needs autumn, and we are unable to secure new, more effective vaccines that protect against new forms,” said Sarah Lavanheim, Assistant Secretary of Public Health and Human Services. Dr.