What is Covaxin, the COVID vaccine not approved in the US?

Coronavirus

(NewsNation Now) — Dr. Anthony Fauci last week addressed Covaxin, a COVID-19 vaccine made in India that has not been approved in the U.S. but is finding its way into the social media feeds of the American public.

“We have enough vaccines, the best vaccines available, in the United States,” Fauci, the chief medical advisor to President Joe Biden, said in response to a question about Covaxin during his Thursday interview with Adrienne Bankert on NewsNation’s “Morning in America.”

When asked about the Covaxin approval timeline, Fauci indicated the interest was surprising.

“I’m puzzled by that question,” he said about Covaxin. “We have more vaccines than we need right now. We just need the people to get vaccinated with the vaccines that we have. The mRNA vaccines are vaccines that are desired by everyone else in the world. So we have what we need; we need to use it.”

So why the interest in Covaxin? How does it compare to the vaccines currently available in the United States?

What makes Covaxin different?

Covaxin is different from the Pfizer-BioNTech and Moderna vaccines in how they are made. Pfizer and Moderna are mRNA vaccines, a relatively new approach that teaches our cells how to make a protein that triggers an immune response inside our bodies, according to the CDC.

Covaxin takes a more traditional approach. It’s made by using a disabled form of the COVID-19 virus to stimulate the immune system. This is similar to Johnson & Johnson’s approach to the vaccine.

Covaxin was developed and manufactured in India by Bharat Biotech, a partner of the publicly traded company Ocugen. It was developed with funding from the National Institutes of Health and requires two shots taken 28 days apart.

Why the interest IN Covaxin?

Covaxin was awarded an emergency-use listing by the World Health Organization in November, which further validates the vaccine. India also announced Monday that it will be the only shot available to children aged 15 to 18 when inoculations begin for that age group next week.

The interest in Covaxin in the U.S. is also being driven by investors whose investment in Ocugen would likely skyrocket if the vaccine was approved by the U.S. Food & Drug Administration.

The question about Covaxin asked in the NewsNation interview was one of dozens submitted through a loosely coordinated campaign to ask Fauci about the Indian vaccine.

Any type of support for Covaxin is amplified by its supporters, including one on Thursday by professional tennis legend Jimmy Connors.

Is Covaxin better than the other vaccines?

The Indian Council for Medical Research, which helped develop Covaxin, says the vaccine’s approach is like a “Bruce Lee assault” because it targets three potentially fatal areas at the same time.

It was created with an adjuvant developed by the NIH, technology that has been lauded by Fauci.

“I am pleased that a novel vaccine adjuvant developed in the United States with NIAID support is part of an efficacious COVID-19 vaccine available to people in India,” Fauci said.

But there’s little data to support that it’s better than the Pfizer and Moderna vaccines. COVID-19 infections are decreasing in India. However, the country has reported a swift rise in omicron cases.

Research compiled by The Economist shows that both Pfizer and Moderna did better at preventing infection and hospitalizations than Covaxin against the delta variant.

Covaxin does have one advantage: It doesn’t require the ultra-cold storage of the American vaccines, which is expensive. That makes Covaxin more attractive to poorer, developing countries.

Health expert Jammi N Rao told Quartz India in early December that “to date, there is no reliable evidence that they necessarily offer wide-ranging protection against new variants that result from multiple points of genetic mutation.

“I can only speculate that it comes not from hard science but from a desire to project Covaxin as better than any other vaccine because it is an indigenously developed vaccine,” Rao told Quartz. “It is therefore understandable why many people would want this theory to be true, but it is not the way of science to promote a theory because it is convenient.”

Will it get approved in the United States?

Fauci mistakenly said on “Morning In America” that Covaxin’s manufacturer, Bharat, had not applied for FDA approval. But his office followed up later that day with this statement: “Bharat Biotech, the company that has developed Covaxin, has applied to the FDA for an emergency use authorization (EUA) for their vaccine. The FDA is currently evaluating the data and no decision has been made.”

“The FDA looks at the data and if the data are in order and give you a good scientific rationale to approve it, the FDA will approve it,” Fauci also said in the “Morning in America” interview. “There are no interventions that are not being approved for reasons other than they’ve either not been submitted for approval or the data are not strong enough to warrant approval.”

Fauci also said he did not think the United States needed another vaccine. Instead, he said, it needed to get more people vaccinated with the vaccines currently approved.

“It’s not alternative. It’s another vaccine,” Fauci said of Covaxin in his appearance on “Morning in America.” “We don’t need another vaccine.”

When asked about its FDA application, a spokesperson for Ocugen gave NewsNation the following statement:

“COVAXIN demonstrated its broad-spectrum safety and efficacy in a large, multicenter, phase 3 clinical trial of more than 25,000 people, where it was proven to be 93.4% effective at preventing severe COVID-19 disease, reducing hospitalizations, and 77.8% effective against the overall disease. In a pediatric, immunobridging trial involving children, aged 2-18 years, the vaccine was shown to generate a neutralizing antibody response against the whole SARS-CoV-2 virus and antibody responses against 3 different viral proteins – S1, NP, RBD – equivalent to what was seen in the phase 3 adult efficacy trial. There were also no severe adverse events reported, such as hospitalizations, pericarditis, myocarditis or blood clots, demonstrating a compelling safety profile. Ocugen submitted a pediatric Emergency Use Authorization (EUA) based on these data to the FDA on Nov. 5, 2021, so that parents and healthcare providers in the U.S. can have a safe and effective vaccine option for their children in the effort to end the coronavirus pandemic.”

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