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A very public regulatory debate about COVID-19 booster shots has seemingly put Pfizer at odds with federal health officials who say it’s not necessary to get another shot at this time.
Pfizer
PFE,
last week reiterated plans to seek emergency authorization for its COVID-19 booster in August, citing data out of Israel that tied waning protection from its vaccine to the more transmissible delta variant. The drug maker also said it’s developing a booster specifically targeting delta, which is now thought to be the dominant strain of the virus in the U.S.
Health officials and medical experts, on the other hand, continue to say there is no scientific case for COVID-19 boosters right now.
“I think people are hesitant to support booster dosing because at least for now it’s unnecessary,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told MarketWatch in an email.
Dr. Anthony Fauci, chief medical adviser to President Joe Biden, on Sunday told CNN that “given the data and the information we have, we do not need to give people a third shot, a boost.” The Centers for Disease Control and Prevention and the Food and Drug Administration put out a joint statement on Thursday saying something similar.
And, in an email sent Friday afternoon and viewed by MarketWatch, National Institutes of Health director Dr. Francis Collins told staff that “Pfizer seems to have gotten way out over their skis here,” indicating that the company may be getting ahead of itself when it comes to boosters.
But if the science evolves and it indicates that boosters are needed, that’s going to present a new set of communication challenges for the Biden administration.
“It’s distracting if people are getting an impression from statements from companies that they need” to get a booster, said Dr. Lynn Goldman, an epidemiologist and dean of the Milken Institute School of Public Health at George Washington University. “We’re still trying to get people to immunize in the first place.”
The vaccination rate in the U.S. has flatlined at 48%. Telling people they need to get a third shot down line could lead to confusion, frustration, or an even more firm “no” from the hesitant.
“When you have so many Americans that are hesitant to get vaccinated, articulating to them that, ‘Hey, the initial vaccines aren’t going to be enough forever, and you’re going to have to do this on a regular occurrence,’ could make them more skeptical of the vaccines and less willing to get vaccinated initially,” said Chris Meekins, a health policy analyst at Raymond James.
The case for boosters is complicated
Many public-health experts have said they expect booster doses will be necessary as immunity wanes and new variants emerge. However, much of that need is going to be based on when protection begins to diminish and in whom.
Some experts believe booster shots will only be recommended for certain vulnerable segments of the population, like the elderly or people who are immunocompromised, and not for generally healthy Americans who want to reinforce the level of protection they already have. An influential CDC committee is expected to meet July 22 to discuss whether immunocompromised people need a booster shot.
“We believe the likely upcoming spike in cases and deaths may tip the balance” in favor of boosters, RBC Capital Markets analyst Brian Abrahams told investors this week. “Should a targeted booster approach be taken, we believe this provides evidence that immunosuppressed individuals and those with co-morbidities should be among the first dosed.”
This discussion is already playing out in other countries.
A group of French doctors published a letter in The New England Journal of Medicine in June that said a third dose of Pfizer’s shot “significantly improved” protection in solid-organ transplant recipients. The U.K. this month published a “potential” COVID-19 booster plan, outlining who can get a third shot depending on age, health status, and profession. Israel is now offering third doses to the immunocompromised.
In the U.S., vaccine makers face a specific set of obstacles. One has to do with ensuring supply at a time when the authorized vaccines developed by Johnson & Johnson
JNJ,
Moderna
MRNA,
and Pfizer are still bound by the requirements of the Defense Production Act, which can require companies based here to give priority to the U.S. during the public-health emergency.
“It looks like the pharmaceutical company is at odds with our federal health officials,” said Dr. Leana Wen, an emergency room physician, “when, actually, this is a matter of the pharmaceutical companies wanting to be prepared, wanting to have the boosters available, if and when they’re needed.”
Moderna is studying booster doses, too. It announced a new deal in June with the U.S. for 200 million doses, “which could be used for primary vaccination, including of children, or possibly as a booster if that becomes necessary to continue to defeat the pandemic,” Moderna CEO Stéphane Bancel said in a news release. The company has signed agreements that could include booster shots with Argentina, Europe, Saudi Arabia, and Switzerland.
Pfizer has not announced any deals that include boosters with the U.S.
“I think the company believes that it can garner public opinion to support a booster over people’s fear of the most recent delta variant and are capitalizing on that opportunity to try to force the government in the direction they want it to go,” Meekins said.
How long does immunity from vaccines last?
In a nutshell: We don’t know. There are a still a number of unanswered questions about the “durability” of immunity.
These include: What is the level of neutralizing antibody titers that still provide protection? Will T-cell response provide immunity if antibodies wane? When will we have a test that assesses antibody levels? When will the FDA establish a “correlate” of protection? Will only the most vulnerable people need a boost?
To further complicate things, this is the first time we’ve had a vaccine for a coronavirus and the first time that mRNA shots have ever been deployed. Those factors create additional unknowns. And so without answers to some or all of these questions, we are largely stuck guessing.
“We basically are operating, in my view, in a fact-free zone,” Goldman said. “I don’t think it at all irrational to get a EUA for boosters right now. I see the rationale. How we talk about it is a different issue.”
Pfizer recently said that immunity provided by its COVID-19 vaccine can wane six to 12 months after full vaccination; other officials believe the length of immunity is close to the tail end of that estimate, including the FDA’s Dr. Peter Marks, who suggested in May that it’s closer to at least one year of protection.
“It’s very unlikely that immunity is just going to fall off a cliff at some point,” Wen said. “More likely, you’re going to see a gradual waning over time…And so I think that is part of the difficulty in translating these complicated messages to sound bites for the general public.”
