With apologies to the late Yankees slugger Yogi Berra, for pandemic-weary Americans, it’s like “déjà vu all over again,” as new lockdowns and mandatory mask mandates are being imposed across the globe. The latest threat, the Omicron COVID-19 variant, has been a major source of breakthrough infections, including among those who have been fully vaccinated and boosted, such as United States Senators Elizabeth Warren and Cory Booker. Pfizer, Moderna, Johnson & Johnson, and other U.S.-based vaccine manufacturers deserve a great deal of credit for proceeding with a sense of urgency in the early days of the pandemic. In less than a year, they turned a COVID-19 vaccine from a vague hope into a market-ready solution to address an unprecedented public health crisis. One class of vaccines might not be the best answer to all phases of the pandemic, though. When asked about a way forward, Pfizer CEO Albert Bourla on December 8 indicated that a fourth dose of the booster is only a matter of time. As a clinician who has received two Pfizer doses and a booster without any side effects, I wholeheartedly embrace vaccination as a solution to this pressing public health crisis. The question, though, is whether public health authorities should remain committed to only one category of vaccine or whether a broader response involving other categories of vaccines would be advisable. The vaccines that Americans have come to love — or hate, depending all too often on their political persuasion, their understanding of the available data and personal biases — are based on mRNA technology. From a scientific perspective, re-administering (or reloading) a vaccine, which would stimulate the production of the same spike-style antibodies to mitigate the infection, is only a temporary “band-aid” approach. Further, the long-term consequences of overloading mRNA vaccines are still unknown. Inactivated vaccines, used for such conditions as seasonal influenza, polio, pertussis, rabies, and Japanese encephalitis, represent the other major category of vaccines. Although Pfizer, Moderna, and Johnson & Johnson have become household names in the COVID-19 vaccine space, the public and the medical community should be aware of an efficacious vaccine, Covaxin (BBV152), which uses the well-established and time-tested inactivated vaccine approach. Over the past 12 months, more than 128 million doses of Covaxin have been administered outside of the United States without any severe adverse side effects. After long scrutiny by the World Health Organization (WHO), Covaxin was finally granted approval for an Emergency Use Listing in November 2021. According to a study in The Lancet, a peer-reviewed medical journal, Covaxin is 93% effective in preventing severe Covid, and its effectiveness in preventing symptomatic Covid (77%) and asymptomatic Covid (63%) is impressive, as well. Most importantly, Phase III clinical trials have shown vaccine efficacy of 71% against all variant-related COVID-19 disease. Covaxin offered 90% efficacy against Kappa and 65.2% against Delta. It also elicits robust immune memory to COVID-19 and variants for at least six months, which suggests that it will have a strong immune response to the Omicron variant. Unfortunately, Covaxin has hit a roadblock in the form of the Food and Drug Administration (FDA) ‘s refusal to grant permission for a Phase III clinical trial in the United States. In June 2021, the FDA turned down an Emergency Use Authorization for Covaxin submitted by Ocugen on behalf of the manufacturer Bharat Biotech. Instead, the FDA recommended that Bharat Biotech/Ocugen seek approval for a Biologics License Application, which would take years to make its way through the approval process. Could the very companies that helped so significantly in the early stages of the pandemic by quickly bringing vaccines to market now be exercising their influence in Washington to ensure that they remain the dominant players in the COVID-19 space, even if such dominance comes at the expense of public health? It’s an uncomfortable question to ask, and perhaps for that reason, very few media outlets or public officials have raised it. Gratitude has its place, but it is not unreasonable for the American people to ask the U.S. pharmaceutical industry, “What have you done for me lately?” Congress should explore whether the phenomenon of “regulatory capture” — which involves an industry exercising undue influence over the activities of the agency that sets the “rules of the game” for the industry’s operations — is standing in the way of what appears to be a safe, effective vaccine to combat COVID-19. Whether in the defense industry, medical device industry or pharmaceutical industry, the connections between the regulator and the regulated are often too collegial to truly protect the interests of taxpayers and patients. Favoritism by regulators comes at the expense of the general welfare of the American people. After one year of free access to vaccination, many Americans are still hesitant to get vaccinated for different reasons. The current mRNA vaccines do not give lifetime protection but rather provide temporary protection (from 3-6 months at the most) until another variant surfaces. Results of a study regarding Covaxin’s effectiveness against the Omicron variant will be released in a couple of weeks. If the results are mediocre, the search for a better vaccine will no doubt continue. However, if the results show positive protection against the Omicron variant, the American people should have the ability to select the best option for their needs without undue interference from the FDA. Former House Speaker Newt Gingrich once observed that Americans place a high value on merit, even if it leads to unequal outcomes. Not all football quarterbacks should be treated like Joe Montana, Gingrich observed, but everyone, he said, should have the opportunity to try out for the team. The FDA should take his aphorism to heart and begin the tryout — the Phase III clinical trial — at the earliest possible opportunity. Will Covaxin make its way to the field, or is it doomed to the dugout in the United States? Merit, not politics or cronyism, should determine the outcome. Pfizer’s Albert Bourla has rightly characterized the behavior of those who circulate COVID-19 vaccine misinformation as “criminal.” So, too, is short-circuiting the evaluation process of a potentially efficacious treatment that could appeal to a broader swath of Americans and, in turn, bring the pandemic’s terrible toll closer to its end. Source
