Covaxin, an inactivated SARS-CoV-2 vaccine and the only vaccine to have been proven effective against all variants including the Delta variant in a Phase III clinical study, deserves to be tested in clinical trials in the U.S. for potential CDC/FDA approval for use in the U.S.

As we are about to celebrate the one-year anniversary of the vaccine rollout against COVID-19, we would do well to remember that despite the progress that has been made in fighting the pandemic through public health efforts in the areas of education, physical distancing, masking, and vaccination, the fight against the pandemic is ongoing.

As The Wall Street Journal reported under the headline, “U.S. Covid-19 Deaths in 2021 Surpass 2020’s,” pandemic-related deaths in 2021 have exceeded the pandemic’s 2020 toll. Looking ahead, the World Health Organization (WHO) estimates 700,000 lives will be lost to COVID-19 across Europe by the spring of 2022, due in part to the loosening of restrictions on gatherings and new strains of the virus.

In addition, Omicron, the latest strain, appeared in South Africa in November 2021 and is now a source of significant concern given its potential impact across the globe. The fact is that the fight against the pandemic is far from over.

The pandemic is not controlled at all, although the three vaccines (Pfizer/BioNTech, Moderna, and J&J/Janssen) currently approved for use in the U.S. have been tremendous in mitigating the symptoms of COVID-19 and reducing the number of deaths related to COVID-19. However, these vaccines have proven incapable of eradicating the pandemic. The third or fourth wave is expected soon in the coming winter.

Currently, about 7.9 billion doses have been administered globally and 36.7 million doses are being administered daily.

About 70% of North America and Europe population have been fully vaccinated and should have thus achieved herd immunity as traditionally defined with 60 to 70% of the population exposed or vaccinated. However, the pandemic is still raging across the world, including in Europe and North America, and tight lockdowns are being considered across Europe.  The Delta variant has accounted for 80 to 99% of new cases since the summer of 2021.  The three vaccines used in the United States were studied and approved prior to the mutation of the Delta variant.

Public health recommendations are supposed to be based on facts and data, but the interpretations of the facts/data about risks and benefits can be completely contradictory from one country to another and can evolve as time goes on. For instance, masks were initially not recommended because public health experts felt that people wouldn’t adjust the masks properly, which would limit the masks’ effectiveness and would do more harm instead.

In addition, some European countries have recently suspended the Moderna vaccine for people under 30, while it is still being used in the United States for adults and is being considered for pediatric use. The definition of herd immunity has also been changed. In addition, fully vaccinated with two doses is being changed to two doses plus booster.

The end of the pandemic is not in sight anytime soon, and the efficacy of the vaccines wanes over 2 to 6 months. A booster every six months or every year is now recommended for most Americans.

The urgency to find a good or better vaccine should remain a high priority as it was in 2020.

Therefore, it is unconscionable that the public would be offered the same boosters repeatedly. Tackling a global issue requires global cooperation, and exploring and studying the other efficacious vaccines by mechanisms other than mRNA is a must for the welfare of the American people.

In these extraordinary times, the Food and Drug Administration (FDA) should facilitate clinical studies of other vaccines, approved by the World Health Organization, for use in the U.S. market.

Currently, the World Health Organization has approved seven vaccines for emergency use: Pfizer-BioNTech (mRNA), Moderna (mRNA), Janssen/J&J (viral vector), Oxford-AstraZeneca (viral vector), Sinopharm BIBP (inactivated virus), CoronaVac (inactivated virus), and Covaxin (inactivated virus).

Five other candidates for consideration are: Sputnik V (viral vector), Sinopharm WIBP (inactivated virus), Convidecia (viral vector), Novavax (protein-based), and Sanofi-GSK (recombinant protein with adjuvant).

The year 2020 was the race to find a vaccine against COVID-19. The United States government allocated $1.2 billion to secure 300 million doses of AstraZeneca COVID-19 vaccine in May of 2020. The AstraZeneca COVID-19 vaccine was the only foreign-made vaccine bought by the U.S. government, but it has not been approved yet “in the United States because the one large-scale trial of the vaccine conducted so far used outdated data.” The purchases in advance of vaccines being developed were based on the prowess and reputation for the quality of the European and American pharmaceutical companies.

Among the seven vaccines approved by WHO, Covaxin is the only foreign-made vaccine whose manufacturer is very interested in bringing it to the American and Canadian public. Bharat Biotech, manufacturer of Covaxin, partnered with an American pharmaceutical company, Ocugen, for the rights to distribute the vaccine in the United States and Canada in February 2021. Then Ocugen entered into a manufacturing partnership with Jubilant HollisterStier in June 2021. These partnerships demonstrate the seriousness of the will of transferring the technology of making Covaxin in the United States for the American public. Unfortunately, the FDA denied approving Covaxin for an emergency use application and instead recommended Bharat Biotech/Ocugen to seek approval for a Biologics License Application, which would take years to gain the approval.

After long scrutiny and review, the WHO finally authorized Covaxin for emergency use on November 3, 2021. Ocugen has recently submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside of the U.S., for pediatric use.  The decision was based on promising results of a Phase II/III pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large extent.

Covaxin is an inactivated SARS-CoV-2 vaccine, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research – National Institute of Virology. According to The Lancet’s peer-review of Covaxin, it is highly efficacious against COVID-19 without any severe adverse effects such as: Guillain-Barre Syndrome, anaphylactic reactions, myocarditis, pericarditis, and vaccine-induced thrombotic thrombocytopenia.

Covaxin is 77.8%, 63.6%, and 93.4% effective at preventing symptomatic, asymptomatic, and severe COVID-19, respectively. Most importantly, Covaxin is the only COVID-19 vaccine tested to have demonstrated efficacy at 65.2% in Phase III clinical trials against the Delta variant (SARS-CoV2, B2.627.2 Delta). Furthermore, more than 110.6 million people in India have received Covaxin without any report of severe adverse effects.

“A new study has also observed strong T cell responses specific to different coronavirus variants,” which was done in collaboration with All India Institute of Medical Sciences, New Delhi, the Translational Health Science and Technology Institute, Faridabad, and the University of California, San Diego. Storage is also more convenient at 2-8 degrees Celsius; the vaccine has a shelf life of 12 months.

The reluctance by the FDA to accept Covaxin for clinical trials can be multifold, but bias might well be one of them; the vaccine is not developed by European or American pharmaceutical companies, which have a longstanding reputation in the marketplace. There is no basis for such bias because India’s excellence in medical science, engineering, information technology, and other fields is well documented.  India has provided the very best scientists, IT engineers, and physicians in the United States for decades. About 30% of physicians practicing in the United States are medical graduates or of Indian origin. The current U.S. Surgeon General, Dr. Vivek Murthy, and Google CEO, Sundar Pichai, are of Indian origin. One of the primary inventors of Moderna vaccine is an Indian scientist, Dr. Mihir Metkar. Even Bharat Biotech was founded and is led by Dr. Krishna Ella, who obtained a Ph.D. from the University of Wisconsin-Madison.

The pandemic situation has not changed much compared to 2020 despite the vaccines that are available; social distancing and mask-wearing remain the norm because the defined herd immunity has not arrested the transmission of the virus. The situation is as urgent as it was in 2020. Therefore, it is time for the FDA to quickly allow clinical studies of Covaxin to assess the potential benefits and risks. A traditional technology of making a vaccine like the one with Covaxin could help to dispel the myth and misinformation associated with the DNA/gene modification with mRNA technology. This would alleviate the fear among vaccine-hesitant individuals by 20 to 25%.

The public’s trust in the public health guidance from institutions at the federal level is critical in fighting the pandemic, which is now unfortunately too politicized. Pfizer CEO Albert Bourla has 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.

Tayson DeLengocky is an ophthalmologist.

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