Pfizer to Seek Approval for Booster COVID Shot, But U.S. Agencies Balk at Timing

FRIDAY, July 9, 2021 (HealthDay News) -- Pfizer and its partner BioNTech announced Thursday they would seek approval for a booster COVID-19 shot and begin studies on a reformulated vaccine that targets the highly contagious Delta variant.

"We continue to believe that it is likely, based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination," the companies behind a highly protective two-dose vaccine said in a statement.

Pfizer-BioNTech said that while protection "remained high" from their vaccine, there's evidence it could wane over time. The advent of new coronavirus variants might also lead to a need for boosters, the companies said.

But just hours after the announcement, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention issued an unusual joint statement saying Americans do not need booster shots yet, and that companies making coronavirus vaccines will not be making the final decision on that.

"We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed," the agencies said in the statement.

"The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta," the agencies added.

Some experts also pushed back on the Pfizer news, calling any decisions around boosters premature.

"There's really no indication for a third booster or a third dose of an mRNA vaccine, given the variants that we have circulating at this time," Dr. Céline Gounder, an infectious disease specialist at Bellevue Hospital Center in New York City, told The New York Times. "In fact, many of us question whether you will ever need boosters."

"If we're worried about variants, our best protection is to get the rest of the world vaccinated, not to hoard more doses to give third doses of mRNA vaccines to people here in the U.S," Gounder added.

"Pfizer looks opportunistic by hanging an announcement on the back of very early and undigested data from Israel," John Moore, a virologist at Weill Cornell Medicine in New York City, told the Times. "When the time is right for using boosters here, the decision isn't theirs to make."

The latest data on the Pfizer vaccine has not yet been published, nor peer-reviewed. The companies said they plan to submit their findings to the FDA in the coming weeks, CNN reported.

Citing data from Israel, Pfizer and BioNTech suggested their vaccine's efficacy "in preventing both infection and symptomatic disease has declined six months post-vaccination."

Health officials in Israel have estimated that the Pfizer-BioNTech vaccine offers only 64 percent efficacy against the Delta variant, the Times reported. It was greater than 90 percent against the original virus.

But Israel's estimates have been contradicted by a number of other studies finding that the vaccine works well against all variants. One recent study showed that mRNA vaccines like Pfizer's trigger a persistent immune reaction in the body that may protect against the coronavirus for years.

COVID death toll passes 4 million globally

The worldwide coronavirus death toll topped 4 million on Thursday, with the highly contagious Delta variant spotted in more than 100 countries and the World Health Organization warning against nations relaxing restrictions too quickly.

"The numbers may not tell the complete story, and yet they're still really staggering numbers globally," Jennifer Nuzzo, an epidemiologist at Johns Hopkins University's Bloomberg School of Public Health in Baltimore, told theTimes.

On Wednesday, Dr. Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, warned countries against opening up too soon.

"Compounded by fast-moving variants and shocking inequity in vaccination, far too many countries in every region of the world are seeing sharp spikes in cases and hospitalizations," he said during a news conference, the Times reported.

Even the Delta variant, which first emerged in India and is now ripping through unvaccinated populations around the globe, "is itself mutating and will continue to do so," said Maria Van Kerkhove, technical lead at the WHO's Health Emergencies Program, the Washington Post reported.

In the United States, the rapid spread of the Delta variant has prompted the federal government to send a COVID-19 surge team to provide public health support in southwest Missouri, where the spread of the virus is filling up hospital beds once again, CNN reported.

The surge of COVID-19 cases is so high in the city of Springfield, Mo., that the CoxHealth hospital system began transferring patients infected with the virus to other facilities to provide better staffing, CNN reported.

Over the past week, Missouri had second highest caseload in the country, with 15.5 new cases per 100,000 people daily, according to Johns Hopkins University data. Arkansas claimed the highest rate, at 15.7 new cases per 100,000 people each day, CNN said.

"We're already starting to see places with low vaccination rates starting to have relatively big spikes from the Delta variant," Dr. Ashish Jha, dean of the Brown University School of Public Health in Rhode Island, told CNN.

"We've seen this in Arkansas, Missouri, Wyoming. ... Those are the places where we're going to see more hospitalizations and deaths as well, unfortunately," he said. "And any time you have large outbreaks, it does become a breeding ground for potentially more variants."

More information

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

SOURCES: The New York Times; CNN