Pfizer sparks thorny debate over COVID-19 booster shots

A divide between Pfizer and the Biden administration over the need for a third dose of the COVID-19 vaccine is sparking a debate over booster shots, with a minefield of complications.

Pfizer made waves last week by saying it would be applying to the Food and Drug Administration (FDA) for authorization for a third shot. The FDA and the Centers for Disease Control and Prevention (CDC) pushed back within hours, issuing a rare joint statement saying booster shots are not needed at this time.

But U.S. health officials did not rule out the possibility that booster shots might be needed later, potentially opening up a range of thorny complications.

For one, health officials are seeking to emphasize that it is still important that people get their first two doses if they have not done so already and that the vaccines are highly effective. In addition, global health advocates are raising alarms that wealthy countries could start giving some people third doses while many vulnerable populations around the world are still waiting for their first shot.

While booster shots may eventually be needed, several experts said they think Pfizer’s announcement was premature.

“I think they definitely jumped the gun,” said Monica Gandhi, professor of medicine at the University of California, San Francisco.

She said that while booster shots may be needed in five or even 10 years, “I definitely don’t think it’s going to be needed yearly.”

Other experts expressed more uncertainty, saying they are simply waiting for more data.

“This is an area where everyone wants an answer before we have data,” said Andrew Pavia, chief of the division of pediatric infectious diseases at the University of Utah.

“To do it prematurely would use up a lot of the vaccine that much of the world needs, as well as divert our efforts from getting people their first dose of vaccine,” Pavia said. “But if we wait too long, then we’re going to have a lot of people who become susceptible again.”

The key metric to watch, experts said, is if there starts to be an increase in fully vaccinated people coming down with serious cases of COVID-19, something that has not happened.

“We are not seeing that people who are vaccinated are at high risk of infection at this point,” Jay Butler, the CDC’s deputy director for infectious diseases, said Tuesday on a call with reporters hosted by the Infectious Diseases Society of America. “The effectiveness of the vaccines appear to be maintained.”

He noted, though, that the question of when and whether booster shots will be needed is being “intensively reviewed” by federal health officials. The two groups most likely to need booster shots are the elderly and those with weakened immune systems, he added.

As the U.S. vaccination rate slows, and the country remains short of President Biden’s July 4 goal of getting 70 percent of adults at least one dose, officials are stressing that talk of the possibility of eventually needing boosters does not mean that it is not worth getting the first two shots.

“This has absolutely nothing to do with the effectiveness of the vaccine,” Anthony Fauci, the nation’s leading infectious diseases expert, said Tuesday on CNBC. “These vaccines are highly, highly effective.”

“It has to do with the durability of the protection,” he added, calling the point something “we really need to clarify.”

More than 99 percent of people dying from COVID-19 are unvaccinated, he said.

Pfizer executives met with U.S. health officials on Monday to brief them about data on the potential need for booster shots, but Fauci indicated that a decision on whether to recommend a booster is not imminent, calling it a “courtesy meeting.”

“It certainly was not anything even approximating a decisional meeting at all,” he said.

Pfizer called the meeting “productive” in a statement and said participants agreed that “scientific data will dictate next steps.”

Some health experts said there could be a financial incentive for Pfizer to want to sell another round of booster doses to wealthy countries.

“Do they want a financial boost?” asked Gandhi, of the University of California.

“No matter what pharmaceutical companies tell you, you don’t need a Covid-19 booster more urgently than all the healthcare workers around the world who haven’t yet had access to a vaccine,” tweeted Craig Spencer, director of global health in emergency medicine at Columbia University.

The World Health Organization (WHO) pushed back on talk of a booster on Monday.

“Currently, data shows us that vaccination offers long lasting immunity against severe and deadly COVID-19,” said WHO Director-General Tedros Adhanom Ghebreyesus. “The priority now must be to vaccinate those who have received no doses and protection.”

Israel announced this week that it would start giving booster doses to people with weakened immune systems, and data out of the country last week raised eyebrows by saying the Pfizer vaccine dropped to 64 percent effectiveness against the delta variant.

But that study was met with widespread skepticism by experts. Gandhi noted that a larger data set from the United Kingdom put effectiveness against the delta variant much higher, at 88 percent.

Pavia, of the University of Utah, said the answer is not clear yet on if and when booster shots will be needed.

“Everyone’s going to keep asking the question, but we’re not going to know the answer until the answer is in,” he said.