FDA Clears 4th COVID-19 Shot for All Americans Aged 50 and Above

A person is injected with Pfizer's COVID-19 vaccine in Dallas, Texas, in a file image. LM Otero/AP Photo

U.S. drug regulators on March 29 announced they’ve granted emergency authorization for a second booster of the Pfizer and Moderna COVID-19 vaccines

The Food and Drug Administration (FDA) is allowing a fourth dose of the jabs to all Americans aged 50 and above.

In addition, Americans aged 12 above with weakened immune systems may get Pfizer’s second booster, and Americans over the age of 18 who are immunocompromised may get a second booster of Moderna’s jab. Some of them could already get four shots, making the booster a fifth shot.

The clearance is for four months after the receipt of an initial booster shot.

The vaccines are built on messenger RNA technology and both are administered in two-dose primary regimens.

Initially promoted as highly effective against both infection and severe disease from the CCP (Chinese Communist Party) virus, which causes COVID-19, the vaccines have performed worse against later strains of the virus, prompting the FDA in 2021 to clear booster doses for many Americans.

But the protection from a single booster shot against infection rapidly wanes, and its shielding against hospitalization also drops over time, paving the way for the new clearance.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,“ Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. ”Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”

The only data the FDA cited comes from Israel.

Surveillance data from Israel’s Ministry of Health of approximately 700,000 people aged 18 and up who received second boosters of Pfizer’s shot did not show any new safety concerns, according to the regulator.

The other piece was an ongoing open-label, non-randomized clinical study in health care workers at a single site, which found minimal potential benefits for young, healthy people from an additional Moderna or Pfizer shot.

The same study revealed no new safety concerns during the three weeks of follow-up, the FDA noted.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, speaks in Washington on March 18, 2021. Susan Walsh/Pool/Getty Images

Based on the studies, the FDA has concluded a second booster “may be effective” and that the “known and potential benefits” outweigh the “known and potential risks” in the populations now authorized to get one, Jacqueline O'Shaughnessy, the FDA’s chief scientist, told Pfizer and Moderna executives in separate letters.

Other data from Israel indicates protection against infection from a second booster quickly drops. Protection against hospitalization was largely maintained, but that is already high after the first booster.

The FDA did not convene its expert advisory panel before clearing the second boosters, although it has a scheduled meeting with the committee on April 6.

Not convening the panel stemmed from the authorization being “a relatively straightforward decision made based on data that was analyzed,” Marks told reporters on a call.

The FDA’s review memorandum, which has not yet been released, will show how an additional booster helps against death and hospitalization, he added.

The Centers for Disease Control and Prevention (CDC) later Tuesday recommended all Americans now eligible to get a second booster should get one.

“This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time,” Dr. Rochelle Walensky, the agency’s director, said in a statement.

Dr. Robert Malone, who helped create the messenger RNA technology, told The Epoch Times that individuals should consult with their doctors before getting another booster.

“The problem is that the true nature of the risks has been hidden from the public and hidden from these individuals that are high-risk. And they ethically must be provided with the full scope of information about the adverse event risks, so that they and their physicians can make an informed decision,” he said. “And I’m adamantly opposed to any mandates associated with further boosting. The data is increasingly suggesting that multiple boosts is creating higher risk for infection and disease with Omicron.”

Omicron is a variant of the CCP virus, also known as SARS-CoV-2.

Marks said the risks associated with an additional booster for older people are “very low.”

Approximately 217 million Americans have received a full primary regimen of a COVID-19 vaccine, with 97 million also getting a booster dose, according to data reported to CDC.

Some 795,783 adverse events following vaccination have been reported to the Vaccine Adverse Event Reporting System, which is jointly run by the FDA and CDC.

News of the FDA’s authorization leaked before it was announced, and drew criticism.

“Is this following the science?” Dr. Marty Makary, a professor surgery at Johns Hopkins Hospital, wrote on Twitter. “FDA will authorize 4th doses this week by bypassing the typical voting process of their external experts. FDA will then convene them after the authoriz[ization] to ‘discuss’. It’s like a judge issuing a verdict and then having lawyers make their arguments.”

But some others said the expanded authorization made sense.

“FDA’s bottom-line assessment required for an EUA—’that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations’—is almost surely correct, despite uncertainties,” according to Jason Schwartz, an associate professor health policy at the Yale School of Public Health.