U.S. Taxpayers Fund $5 Billion Project NextGen to Develop Novel COVID Vaccines and Drugs

Just three months after the Biden administration announced that U.S. taxpayers would fund a $5 billion initiative called Project NextGen to develop “next generation” COVID-19 vaccines and therapeutics, the U.S. Department of Health and Human Services (HHS) awarded $1.4 billion in contracts under the program on Aug. 22, 2023. The total includes “$1 billion for COVID vaccine clinical trials, $326 million to create a new COVID monoclonal antibody drug, and $100 million to develop novel COVID vaccines and therapeutic technologies.”^{1 2 3}

The HHS awards come on the heels of Pfizer implementing cost-cutting measures after sales for its Comirnaty messenger RNA (mRNA) COVID biologic and Paxlovid, a protease inhibitor drug, saw sharp declines this year. After Pfizer’s COVID products underperformed in 2023, the company predicted a rise in infection rates this fall that will inform its future sale strategy in the COVID market as it transitions from a government-dominated sales market to a commercial one.

However, reported cases of new SARS-CoV-2 infections in the U.S. have been rising sooner than expected, with public health officials tracking three new SARS-CoV-2 variants, including EG.5, FL.1.5.1, and BA.2.86. Coinciding with Project NextGen, the latest surge in COVID cases has led some universities and companies to reinstate the mask mandates in yet another repeat effort to “slow the spread” of the new SARS-CoV-2 variants. ³

Mask Wearing Reduced the Risk of Coronavirus Infection and Death by Only Five Percent

Throughout the pandemic, health officials in countries have been divided over whether face coverings effectively prevent the transmission of SARS-CoV-2 infections. Research conducted by Cochrane of London, England has provided substantial evidence to resolve this uncertainty. The Cochrane analysis of 78 global studies involving over one million people published on Jan. 30, 2023, found that masks only reduced the risk of SARS-CoV-2 infection and death by a mere five percent, and authors asserted that the benefits of mask-wearing and mask mandates did not outweigh the risks, such as impeding children’s academic and cognitive development in their early years.⁴

Considered the “gold standard” in assessing evidence-based medicine and public health policies, Cochrane reviews follow a rigorous methodology, are generally less vulnerable to bias, and only consider high-quality evidence in their systematic reviews that investigate the effects of interventions for disease prevention, treatment, and rehabilitation.⁵

In response to Cochrane’s new findings, Francois Balloux, PhD, director of the UCL Genetics Institute and professor of computational biology at University College London, wrote:

Irrespective of the limitations of the study, its results indicate that the true impact of medical/surgical masks and N95/P2 respirators on the transmission of respiratory viruses is at best small. ⁶

Other key findings by Cochrane included: there were no clear differences between the use of medical/surgical masks compared with N95/P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection; and community mask-wearing makes little to no difference in lab-confirmed infections, compared to not masking. However, the authors concluded that immunocompromised or vulnerable individuals may benefit from mask-wearing, since interventions that are not effective at a population level may still provide a personal benefit to at-risk individuals.

Vaccine Failure Persists as CDC Suggests New Variants May Evade Natural and Vaccine-Acquired Immunity

Health authorities warn that the highly mutated BA.2.86 lineage of coronavirus may be more capable than its predecessors to cause infection in people who have been vaccinated for COVID or have been previously infected with SARS-CoV-2. The U.S. Centers for Disease Control and Prevention (CDC) said that, due to the high number of mutations detected in this new SARS-CoV-2 strain, it may be more efficient at evading immunity from vaccines and previous infections.⁷

The federal health agency abruptly stopped tracking breakthrough infections, or instances of vaccine failure in 2021, choosing to only include data on breakthrough infections that result in hospitalizations and deaths.⁸ Newer COVID booster shots, which COVID vaccine manufacturers and health officials claim will prevent serious complications from infection with an Omicron subvariant known as XBB.1.5, are expected to be available by the end of this month.^{9 10}

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