Biden Administration Doles Out Another $500 Million for ‘Next Generation’ COVID-19 Vaccines

President Joe Biden receives a bivalent COVID-19 booster shot in the South Court Auditorium of the Eisenhower Executive Office Building, next to the White House, in Washington on Oct. 25, 2022. (Saul Loeb/AFP via Getty Images)

The Biden administration has announced that it’s investing another $500 million for the development of “next generation” COVID-19 vaccines and drugs because the existing ones don’t protect well against current strains of the virus.

The batch of new money is being awarded under the administration’s Project NextGen, the U.S. Department of Health and Human Services (HHS) said in an Oct. 13 statement, which notes that the agency has already picked a number of initial “next generation” vaccine candidates and has awarded over $500 million to kick-start their development.

“The Biden-Harris Administration is committed to keeping people safe from COVID-19,” HHS Secretary Xavier Becerra said in a statement. “By investing in next-generation vaccines and treatments, we can improve our ability to respond to new variants, reduce transmission, stop infections, and save lives.”

Around $30 million will go to three companies—CastleVax, Codagenix, and Gritstone Bio—to help their respective vaccine candidates with phase-two clinical trials.

Syringes filled with COVID-19 vaccine sit on a table at a COVID-19 vaccination clinic in a file image. (Justin Sullivan/Getty Images)

All three vaccine selections use different technologies, including intranasal versions that HHS says have the potential to stop viruses at the site of infection, and a “self-amplifying mRNA” one that is hoped to generate a stronger immune response than current vaccines as the virus that causes COVID-19 continues to mutate.

Another $240 million is being earmarked for technologies that help with clinical trials, including cold-chain sample management, genomic sequencing, and increased laboratory capacity.

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A further $241 million is being allocated for various other measures meant to help with preparedness for future COVID-19 outbreaks, including developing patches for vaccine delivery, mRNA-expressed monoclonal antibodies, and tissue chip platform technology.

The latest award builds on an earlier $1.4 billion award for the development of both vaccines and therapeutics.

A researcher works on a COVID-19 vaccine at the Copenhagen's University research lab in Copenhagen, Denmark, on March 23, 2020. (Thibault Savary/AFP via Getty Images)

Waning Vaccine Effectiveness

Protection from COVID-19 vaccines started to wane over time, even with the early strains of the virus.

But as newer variants emerged, existing vaccines started to perform even worse—and wane even faster.

In fact, protection offered by current vaccines against more recent variants has even turned negative, according to some observational data presented in June 2023.

Effectiveness against hospitalization plunged to negative 8 percent for people who received one of the old COVID-19 vaccines, according to data from a hospital network run by the Centers for Disease Control and Prevention (CDC).

The data shows that a dose of one of the updated bivalent vaccines from Pfizer and Moderna raised the protection above zero (to 29 percent)—but then protection fell back to negative 8 percent after roughly three months.

Other papers have also estimated that protection against infection turns negative over time. Some datasets have indicated that vaccinated people were at higher risk of hospitalization, long considered a proxy for severe outcomes from COVID-19 infection.

Calls for New Vaccines

In light of waning vaccine effectiveness, U.S. health officials have said that new vaccine formulations are needed.

“There appears to be an inverse relationship between the time since vaccination and vaccine effectiveness, such that bivalent COVID-19 vaccine effectiveness against Omicron sublineages appears to wane over time,” Food and Drug Administration (FDA) officials said in June 2023.

Existing vaccines were already updated in late 2022 to focus on existing virus variants, in hopes that they would do a better job of protecting people than the old vaccine formulations.

But data from the United States and elsewhere has shown that the updated shots have been providing subpar protection against infection and short-lived shielding against hospitalization.

The FDA and other regulators have been moving toward a COVID-19 vaccination model similar to the one for flu vaccines, which involves regularly updated formulations to target newly emergent viral mutations.

The latest batch of COVID-19 boosters from Pfizer and Moderna, meant to target a newer strain of the virus, were approved by the FDA on Sept. 11—drawing criticism because of limited clinical trial data.

In a statement announcing its approval, the FDA said that the decision was supported by its evaluation of “manufacturing data” from vaccine producers and “non-clinical immune response data on the updated formulations including the XBB.1.5 component.”

The risk-benefit profile of earlier versions of the vaccines is “well understood,” the FDA claimed, adding that the similar manufacturing process for the updated vaccines “suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.”

The Centers for Disease Control and Prevention (CDC) followed with its own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines.

However, virologist Dr. Robert Malone accused the FDA of having “gone rogue” by sacrificing its own rules and regulations with its recommendation for the updated vaccines, arguing that there’s only limited clinical trial data attesting to their efficacy and safety.

“It’s difficult to conclude anything other than the FDA is no longer feeling bound by their own rules and regulations,” Dr. Malone said in an interview on EpochTV’s “Crossroads” program. “The term is—they’ve gone rogue.”

The FDA did not respond to a request for comment.

Zachary Stieber contributed to this report.