In a move to expand the bouquet of COVID-19 vaccines for Indians, Health Minister Dr Mansukh Mandaviya on Tuesday, 28 December, announced that the Central Drugs Standard Control Organisation (CDSCO) has approved Covovax vaccine. The vaccine is manufactured in India by Serum Institute of India (SII) in collaboration with Novavax.

The World Health Organization had earlier on approved the Indian version of Novavax, called the Covovax, for emergency use on Friday, 17 December 2021, the ninth COVID-19 vaccine to be added to WHO's Emergency Use List (EUL).

This was followed on 21 December by the WHO approval of the third dose of Novavax ( NVAX.O) for immunocompromised people.

How does the vaccine work? Who is it approved for? What is the dosage gap?

FIT answers:

Covovax is a protein subunit vaccine that targets the spike protein of the COVID virus to help the body develop immunity against the virus.

It is a two-dose vaccine just like the Pfizer, Moderna, AstraZeneca, and Covaxin Vaccines.

And like these vaccines, Covovax targets the spike protein on the surface of the SARS-CoV-2 coronavirus.

But, it uses a different platform, and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.

The vaccine was found to have an efficacy of over 90 percent against the original strain as well as emerging variants of the COVID-19 virus. This was before the Omicron variant was identified.

In June, Novavax had announced that its vaccine was found to have an efficacy of over 90 percent against the original strain as well as emerging variants of the COVID-19 virus. This was before the Omicron variant was identified.

According to the govt press release, Serum has conducted Phase II/III immuno bridging clinical trial in the country for comparing safety and immunogenicity of Covovax & Novavax vaccines.

This data has not been publicly shared.

The CDSCO sites both the US/UK trial data and Serum's bridging trial data in its approval.

Currently, the vaccine has been approved on for adults above the age of 18.

In November, SII announced that it had expanded the trials to include children in the two to six year age bracket across 10 sites in India. They have a previous approval to conduct trails on children between 7 to 11 years of age after giving approvals for 12 to 18 year olds to be included in the trials in July.

The subject expert committee of the CDSCO has recommended a 21 day dosage gap for the two doses.

The vaccine is stored at 2˚C to 8˚C temperature.

WHO's Strategic Advisory Group of Experts on Immunisation (SAGE) had recommended a gap of three to four weeks between the two doses of Novavax.

Details of the dosage gap in India are awaited.

As of now there is no data regarding how well the vaccine protects against the Omicron variant.

However, in their statement while approving the vaccine, the WHO hadexpressed confidence in Covovax's efficacy against all variants of concern that are currently in circulation.

“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products in a statement.

According to the statement put out by the WHO, the vaccine is not recommended for,

• Kids under the age f 18.

• People who are allergic to any of the ingredients of the vaccine or have a history of anaphylaxis.

• People who have a body temperature of over 38.5^o Celsius.

• Those who are COVID-19 positive, especially symptomatic cases.