Biden admin grants $500M for ‘Next Gen’ COVID-19 vaccines.
The Biden Administration Invests $500 Million in Next-Generation COVID-19 Vaccines and Drugs
The Biden administration has recently announced a significant investment of $500 million for the development of “next generation” COVID-19 vaccines and drugs. This decision comes as a response to the existing vaccines‘ limited effectiveness 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. The agency has already selected several initial “next generation” vaccine candidates and has allocated over $500 million to accelerate their development.
HHS Secretary Xavier Becerra stated, “The Biden-Harris Administration is committed to keeping people safe from COVID-19. 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.”
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Around $30 million of the funding will be allocated to CastleVax, Codagenix, and Gritstone Bio, supporting their respective vaccine candidates in phase-two clinical trials.
All three vaccine selections utilize different technologies, including intranasal versions that can stop viruses at the site of infection. Additionally, a “self-amplifying mRNA” vaccine is expected to generate a stronger immune response as the virus continues to mutate.
An additional $240 million will be dedicated to technologies that aid in clinical trials, such as cold-chain sample management, genomic sequencing, and increased laboratory capacity.
Furthermore, $241 million will be allocated for various measures aimed at enhancing preparedness for future COVID-19 outbreaks. These measures include 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.
Waning Vaccine Effectiveness
Over time, the effectiveness of COVID-19 vaccines has started to decline, even against early strains of the virus.
However, as newer variants emerged, the performance of existing vaccines worsened and their effectiveness diminished even more rapidly. In fact, observational data presented in June 2023 suggests that the protection offered by current vaccines against recent variants has turned negative.
According to data from the Centers for Disease Control and Prevention (CDC), the effectiveness of one of the old COVID-19 vaccines against hospitalization dropped to negative 8 percent. However, a dose of one of the updated bivalent vaccines from Pfizer and Moderna raised the protection to 29 percent, only to fall back to negative 8 percent after approximately three months.
Other studies have also indicated that protection against infection diminishes over time. Some datasets have even suggested that vaccinated individuals are at a higher risk of hospitalization, which is considered a severe outcome of COVID-19 infection.
Calls for New Vaccines
In response to the declining effectiveness of vaccines, U.S. health officials have emphasized the need for new vaccine formulations.
In June 2023, Food and Drug Administration (FDA) officials stated, “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.”
Existing vaccines were already updated in late 2022 to target existing virus variants, with the hope of providing better protection than the previous formulations. However, data from the United States and other countries has shown that the updated shots offer subpar protection against infection and short-lived shielding against hospitalization.
The FDA and other regulators are now moving towards a COVID-19 vaccination model similar to that of flu vaccines, which involves regularly updated formulations to target newly emergent viral mutations.
The latest batch of COVID-19 boosters from Pfizer and Moderna, designed to target a newer strain of the virus, were approved by the FDA on Sept. 11. However, this decision drew criticism due to limited clinical trial data.
In a statement announcing its approval, the FDA claimed that the decision was supported by manufacturing data from vaccine producers and non-clinical immune response data on the updated formulations. The FDA stated that the risk-benefit profile of earlier versions of the vaccines is well understood and that the similar manufacturing process for the updated vaccines suggests they are a good match for protecting against the currently circulating COVID-19 variants.
The Centers for Disease Control and Prevention (CDC) subsequently recommended that nearly all Americans receive the new vaccines.
However, virologist Dr. Robert Malone criticized the FDA for disregarding its own rules and regulations by recommending the updated vaccines, as there is limited clinical trial data regarding 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. “The term is—they’ve gone rogue.”
The FDA did not respond to a request for comment.
Zachary Stieber contributed to this report.
As the effectiveness of existing vaccines diminishes over time, it becomes crucial to prioritize the production and distribution of updated vaccines. This not only ensures that individuals receive the best protection against the evolving virus, but also helps control its spread and mitigate the impact on public health.
Hown that the effectiveness of these updated vaccines has also diminished over time.
The emergence of new variants, such as the Omicron variant, has further exacerbated the need for new vaccines. Studies have shown that existing vaccines offer limited protection against these variants, and in some cases, their effectiveness has even turned negative. This means that vaccinated individuals may be at a higher risk of infection and hospitalization compared to those who are unvaccinated.
Recognizing the urgency of the situation, the Biden administration has made a bold move by investing $500 million in the development of next-generation COVID-19 vaccines and drugs. This significant investment will support the advancement of several vaccine candidates that utilize different technologies. Among them are intranasal versions that can target the site of infection, as well as “self-amplifying mRNA” vaccines that are expected to generate a stronger immune response.
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