Pfizer Presses U.S. Scientists, Officials on Third Booster Shot

Pfizer made its case for quick U.S. approval of a third booster shot of its coronavirus vaccine during a meeting with the country’s top scientists and federal regulators on Monday.

The online meeting, convened by the U.S. Department of Health and Human Services (HHS), came the same day that Israel began to give third doses of the Pfizer vaccine to heart transplant patients and others with compromised immune systems.

Still, U.S. officials said after the meeting that more data would be needed before regulators could determine whether booster shots were necessary, The New York Times reported.

“It was an interesting meeting. They shared their data. There wasn’t anything resembling a decision,” Dr. Anthony Fauci told the Times. “This is just one piece of a much bigger puzzle, and it’s one part of the data, so there isn’t a question of a convincing case one way or the other.”

Pfizer spokeswoman Amy Rose said in a statement that, “We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data.”

The HHS issued its own statement after the meeting. “At this time, fully vaccinated Americans do not need a booster shot,” it said.

The latest developments highlight the intense debate that is brewing about whether booster shots are needed in the United States, when and for whom. Many American experts, including Fauci, have said there isn’t enough evidence yet to prove that boosters are necessary. But some suggest Israel’s move may foreshadow a U.S. government decision to at least recommend them for the vulnerable.

The final decision on booster shots will depend in part on real-world data gathered by the U.S. Centers for Disease Control and Prevention about breakthrough infections in vaccinated people that cause serious disease or hospitalization, several officials said after the meeting, the Times reported.

If booster shots are recommended, they might first go to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait, the Times said. And then there is the question of what kind of booster: a third dose of the original vaccine, or perhaps a shot tailored to the highly infectious Delta variant, which is surging in the United States.

“At this point, the most important booster we need is to get people vaccinated,” Dr. Carlos del Rio, an infectious disease expert at Emory University in Atlanta, told the Times. The booster doses in Israel, he added, “will help us answer some questions, but at the end of the day I don’t agree with what they’re doing. I think it’s awfully premature.”

Within the Biden administration, some fear that if Americans think coronavirus vaccines provide only short-lived immunity, they will be less likely to accept a shot. But if new data from Israel shows that immunity wanes after six to eight months, it significantly raises infection risk for the elderly or other vulnerable populations.

Monday’s high-level meeting was prompted by Pfizer’s announcement last week that it is developing a version of its vaccine that targets the Delta variant, and that there have been promising results in studies of people who received a third dose of the original vaccine six months after the second shot, the Times reported.

FDA Adds Guillain-Barre Warning to J&J COVID Vaccine

The FDA issued a new warning on Monday for the Johnson & Johnson coronavirus vaccine that says the shot has been tied to a rare autoimmune condition known as Guillain-Barré syndrome.

Despite the fact that health officials have found that the chances of developing the condition are low, they are still three to five times higher among those who have gotten the J&J vaccine than among the general population, people familiar with the decision told the Times. The latest warning was attached to fact sheets about the vaccine for providers and patients.

Federal officials have identified 100 suspected cases of Guillain-Barré among the 12.8 million people who have gotten the J&J vaccine through a national monitoring system that patients and health care providers can use to report adverse effects of vaccines. Ninety-five percent of those cases required hospitalization, the Times reported.

In a statement, the FDA said that while “the available evidence suggests an association” between the J&J vaccine and increased risk of Guillain–Barré syndrome, “it is insufficient to establish a causal relationship.”

The impending warning will deliver yet another blow to a vaccine that had been widely anticipated for its ease of use — it requires only a single dose — but which has also been haunted by problems.

The 100 cases have largely been reported about two weeks after vaccination and occurred mostly in men, many aged 50 and older. Most people fully recover, but a few have permanent nerve damage, according to the CDC.

While the cause of the syndrome is not fully understood, it tends to follow infection with a virus such as the flu or bacteria. Each year, an estimated 3,000 to 6,000 Americans develop the illness, according to the CDC.

In April, U.S. officials paused use of the J&J vaccine after it was linked to another rare side effect — severe blood clots. That pause was lifted within days following a safety review by the FDA and CDC, and a warning label on the association was added to the product.

“It’s not surprising to find these types of adverse events associated with vaccination,” Dr. Luciana Borio, a former acting chief scientist at the FDA under President Barack Obama, told the Times. The data collected so far suggest that the vaccine’s benefits “continue to vastly outweigh the risks,” Borio added.

Other COVID-19 vaccines have been linked to rare adverse events. The FDA in late June decided to add a warning to the Pfizer and Moderna coronavirus vaccines about mild, extremely unusual cases of heart inflammation in some young adults and teens after vaccination. Federal health officials said there was “a likely association,” and that the problem appears most likely to occur in young men after they receive two doses of the vaccine.

At the time, the CDC and the HHS, together with 15 of the country’s leading medical and public health organizations, issued a joint statement saying they “strongly encourage everyone 12 and older” to get the shots because the benefits far outweigh any potential harms.

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19.

SOURCES: The New York Times; Washington Post

Source: HealthDay