Sept. 17, 2021, 9:10 a.m. EDT

Scientists continue to say there isn’t enough evidence to make COVID-19 boosters available to all Americans

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Jaimy Lee

The U.S. is days away from President Joe Biden’s target date to begin rolling out COVID-19 booster shots to Americans even though experts still say there isn’t a scientific case for boosting the entire eligible population.

The Biden administration announced last month that adults vaccinated with the shots developed by BioNTech SE /zigman2/quotes/214419716/composite BNTX +3.85% /Pfizer Inc. /zigman2/quotes/202877789/composite PFE +0.89% and Moderna Inc. /zigman2/quotes/205619834/composite MRNA +1.55% will qualify for a third dose starting Sept. 20 as long as it’s been eight months since they received their first round of shots and U.S. regulators give the ‘OK.’

But the plan has been criticized by medical experts , who say there isn’t enough clinical data demonstrating all Americans vaccinated with the mRNA shots need a booster because they now face a higher risk of severe disease if they do get sick.

“Is it necessary at this point? Does the data justify a mass rollout to 150 million [or] 200 million Americans who are younger and in good health?” asked John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. “What we have got to get away from is this idea that the vaccines are failing, because they’re just not.”

Everyone agrees that giving an extra dose of the vaccines to people who are immunocompromised is a scientifically sound idea; however, the logic for broad administration of COVID-19 booster shots is murky, at best, and scientists and medical experts continue to push back against the lack of evidence.

A group of scientists, including two senior FDA officials who are reportedly retiring later this year, wrote in an opinion piece published Monday in the influential medical journal The Lancet that the “currently available evidence does not show the need for widespread use of booster vaccination” among people who have already been vaccinated.

That assessment came out days before a group of independent advisers is scheduled to meet Friday to discuss whether the FDA should approve BioNTech and Pfizer’s booster shot. The FDA published its own view of the companies’ application for a booster dose on Wednesday, saying that all COVID-19 vaccines in the U.S. continue to provide strong protection against severe disease.

Pfizer’s document , also published Wednesday, argues that everyone who is at least 16 years old who received its vaccine should get a booster. The drug maker’s position is that even though the vaccine continues to protect against hospitalization and severe disease in the U.S., that could change, based on what Pfizer is saying is happening right now in Israel.

Policy makers should consider boosters as a way “to help control heightened transmission of B.1.617.2 (delta) as we enter the upcoming fall/winter viral respiratory season,” Pfizer said.

(Moderna has also filed an application for authorization of a third dose of its COVID-19 vaccine as its vaccine is not yet fully approved by the FDA. Johnson & Johnson /zigman2/quotes/201724570/composite JNJ +1.57% has not filed for authorization of a booster shot at this time.) 

Here’s why the debate about COVID-19 boosters is so complicated

The public-health goal in the pandemic has always been to prevent severe disease, and right now the majority of severe cases, including those that end in hospitalization and death, are occurring in the unvaccinated.

So, even though the number of breakthrough cases among the vaccinated is increasing, it doesn’t change the goal to include preventing infection.

“At this point I am not convinced that boosting of the general population is needed,” Dr. Carlos del Rio, an infectious-disease physician and executive associate dean of the Emory University School of Medicine, said in an email. “There is some evidence from Israel that it may be important for those [older than] 60 years old but for the general population I don’t think that is the case.”

Further, we don’t know if the increase in COVID-19 cases among the vaccinated has more to do with waning immunity or the spread of the more transmissible delta variant. (Pfizer attributes the breakthrough cases to waning immunity.) It’s also unclear what role the relaxation of mitigation measures like wearing masks and social distancing played in the summer surge in cases, which is an issue raised in the Lancet piece.

“Even without any changes in vaccine efficacy, increasing success in delivering vaccines to large populations will inevitably lead to increasing numbers of breakthrough cases, especially if vaccination leads to behavioral changes in vaccinees,” the scientists wrote.

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