Covaxin vaccine takes another step; Cofepris experts approve it

The Federal Commission for the Protection against Health Risks (Cofepris), unanimously gave its favorable opinion of the Covaxin vaccine against COVID-19, originally from India developed by Bharat Biotech International Limited.

As part of a new optimization procedure, the New Molecules Committee (CMN), made up of experts in their field, issued its favorable technical opinion last Friday through the agency.

“Cofepris informs that the Covaxin vaccine has received a unanimous favorable opinion from the experts, which must be included in its file to be presented to the Health Authorization Commission,” the agency said.

decision is part of the approval process required by Cofepris to meet the quality, safety and efficacy requirements necessary when approving a product.

The CMN optimization process, considers three principles to render its verdict:

– Priority of focus: in what order are the new molecules discussed

– Structural simplification: scheduled and virtual sessions

– Transparency and fairness: results of expert opinions without opacity

In this way, Cofepris is committed to continuing to inform about the opinions and sessions of the CMN.

It should be noted that, according to AFP, the Covaxin vaccine from the Indian company Bharat Biotech has been criticized for launching its biologic before its final trials, but it indicates that it is almost 81% effective in immunizing the SARS-CoV-2 virus.

“Covaxin (not only) demonstrates a trend towards high clinical efficacy against COVID, but also a immunogenicity (ability of an antigen to induce an immune response) significant against variants that emerge unexpectedly, ”Bharat Biotech President Krishna Ella noted in a newsletter.

In this sense, the pharmaceutical leader pointed out that in phase three of the trials, 25,800 people participated, who received a vaccine or a placebo. Among them, they analyzed 43 cases of COVID patients who presented mild to moderate and severe symptoms; of which 36 were from the placebo group and seven from those who received the antigen.

Likewise, the company indicated that “serious side effects, requiring medical assistance, were at very low levels, and they were balanced between the vaccine and placebo groups ”.

Additionally, from Covaxin and Covishield, AstraZeneca and the University of Oxford, they are made in India, with both vaccines licensed in the country.

According to data from Millennium, This antigen uses a platform technology derived from inactive Vero cells, which “do not replicate and therefore are unlikely to reverse and cause pathological effects.”

In other words, they have killed viruses that are incapable of making a person sick, but still have the ability to ask the immune system to build up defenses against possible infection.

To be effective, it is necessary that two doses of the vaccine, which should be administered 28 days apart. Unlike others like AstraZeneca, no sub-zero storage required, since its presentation is liquid, ready to use in multidose vials, stable between 2 and 8 degrees.

The Ministry of Health (In) report that until this Saturday March 6, they have registered 190,357 cumulative deaths due to illness. The above represents an increase of 779 deaths due to the disease In last 24 hours.

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