The highly public regulatory debate on COVID-19 booster shots seems to be at odds with federal health officials who say Pfizer does not need to take another shot at this time.
Repeat last week plan Ask for urgent permission About COVID-19 booster in August Data from Israel It linked the decline in protection from the vaccine to the more contagious delta mutants. The drug company also said it is developing boosters that specifically target Delta. Delta is currently considered the predominant strain of the virus in the United States.
Meanwhile, health officials and medical professionals continue to say that there are currently no scientific cases of COVID-19 boosters.
Dr. Paul Offit, director of the Vaccine Education Center at Philadelphia Children’s Hospital, told MarketWatch in an email:
Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden on Sunday Told to CNN “With the data and information we have, we don’t have to give people a third shot.” The Centers for Disease Control and Prevention and the Food and Drug Administration Joint statement I’m saying something similar to Thursday.
“Pfizer seems to have survived skiing here,” Dr. Francis Collins, director of the National Institutes of Health, told staff in an email sent Friday afternoon and viewed by MarketWatch. It will be a booster.
But as science evolves and shows the need for boosters, it presents a new set of communication challenges to the Biden administration.
“It’s distracting when people are impressed by statements from companies that need them,” said Dr. Lynn Goldman, an epidemiologist and dean of the Milken Institute’s School of Public Health at George Washington University. “We are still trying to immunize people in the first place.”
U.S. immunization rates are flat At 48%.. Telling people that a third shot needs to be downlined can lead to a more solid “no” from those who are confused, frustrated, or hesitant.
“If so many Americans are hesitant to vaccinate,” Hey, the first vaccine isn’t enough forever and you have to do this on a regular basis, “he clearly states. It can increase skepticism about vaccines and discourage them from getting the vaccine first, “said Chris Mekins, a health policy analyst at Raymond James.
Complex for boosters
Many public health experts say They expect booster doses to be needed As immunity weakens and new variants emerge. However, much of that need is based on when and to whom protection begins to decline.
Some experts say that booster shots are recommended only for certain vulnerable segments of the population, such as the elderly and people with immunodeficiency, and for generally healthy Americans who want to enhance the level of protection they already have. I don’t think it is recommended.
Brian Abrahams, an analyst at RBC Capital Markets, told investors this week that “future incidents and a surge in deaths could upset the balance.” “If a targeted booster immune approach is adopted, we believe this provides evidence that immunosuppressed individuals and individuals with comorbidities should be administered first.”
This discussion is already taking place in other countries.
A group of French doctors letter The New England Journal of Medicine in June stated that the third dose of Pfizer’s shot “significantly improved” the protection of solid organ transplant recipients. UK this month “Potential” COVID-19 Booster PlanOutline who can get the third shot according to age, health condition and occupation. Israel is currently offering a third dose to immunocompromised patients.
In the United States, vaccine manufacturers face a specific set of obstacles.It has to do with securing the supply when the licensed vaccine developed by Johnson & Johnson is supplied.
Pfizer is still bound by the requirements of the Defense Production Act, which may require companies based here to prioritize the United States in a public health emergency.
“Pharmaceutical companies seem to be at odds with our federal health authorities,” said Dr. Lina Wen, a doctor in the emergency room. Boosters are available as needed. “
Moderna is also studying the booster effect.It announced New contract Moderna CEO Stephane Bancel said in a news release that he had 200 million doses in the United States in June and was “needed to be used for primary vaccination, including children, or to defeat the pandemic. If so, it can be used as a booster. ” The company has signed contracts that may include booster shots with Argentina, Europe, Saudi Arabia and Switzerland.
Pfizer has not announced a deal with the United States, including boosters
“The company believes it can gather public opinion in support of boosting people’s fears of the latest delta variants and is taking advantage of that opportunity to force the government in the direction they want.” Mr. Mekins said.
How long does vaccine immunity last?
In a nutshell: I don’t know. There are still many unanswered questions about the “durability” of immunity.
These include: What are the levels of neutralizing antibody titers that still provide protection? Does the T cell response provide immunity when the antibody is weakened? When are tests done to assess antibody levels? When does the FDA establish a “correlation” of protection? Do only the most vulnerable people need a boost?
To complicate matters, this is the first time that a coronavirus has been vaccinated and this is the first time that an mRNA shot has been deployed. These factors create additional unknowns. So if we can’t answer some or all of these questions, we’re almost stuck in guessing.
“In our view, we operate in a zone that is basically factless,” says Goldman. “I don’t think it’s totally unreasonable to get a booster EUA right now. I know the rationale. How we talk about it is another matter.”
Pfizer recently stated that the immunity provided by the COVID-19 vaccine can diminish 6-12 months after complete vaccination. Other officials believe that immunity length is near the end of its estimates, including Dr. Peter Marks of the FDA, who suggested in May that it was close to at least a year of protection.
“It’s very unlikely that your immune system will fall off a cliff at some point,” Wen said. “Maybe it will gradually decline over time … and I think that’s part of the difficulty of translating these complex messages into sound bites for the general public.”
Pfizer is making a case for the COVID-19 booster. Health officials say they don’t need a third dose yet. Who is right?
Source link Pfizer is making a case for the COVID-19 booster. Health officials say they don’t need a third dose yet. Who is right?