Covovax | Business Upturn

WHO approves SII’s Covovax for emergency use

Shifali Gorka — Sat, 18 Dec 2021 06:12:54 +0000

On Friday, The World health organization approved the COVID-19 vaccine Covovax which is developed by the Serum Institute of India for emergency use.

Covovax is the version of NVX-CoV2373, the protein-based coronavirus vaccine produced by Novavax, USA. Last year, the two companies had an agreement under which Novavax had given SII the license to produce and supply the vaccine to low-income countries including India.

“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 Mariângela Simão, WHO assistant-director general for Access to Medicines and Health Products. “This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”

SSI started the manufacturing of the Novavax COVID-19 vaccine (branded as Covovax in India) on 26 May 2021 after receiving permission from the Indian government. The vaccine appeared to have effective results and received a good response. The vaccine is given in two doses administered 21 days apart

CDSCO allows Serum Institute of India to start COVID-19 vaccine trials on age group 7- 11 years

Cheryll Jain — Tue, 28 Sep 2021 09:44:26 +0000

Serum Institute of India, which has been producing the Covisheild vaccine, has been approved by the Government of India on Tuesday, September 28 to enrol children between the ages of 7 and 11 years for its COVID-19 vaccine trial.

“After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol,” a subject expert panel of the Central Drugs Standard Control Organisation (CDSCO), the National Regulatory Authority of India, said.

The Serum Institue of India has already conducted the first trials on select participants in the 12 to 17 years age group for its COVID-19 vaccine Covovax, which is a domestic variant of US-based Novavax’s NVAX.O vaccine shot, and reported safety data for an initial 100 participants.

This move by the Central Drugs Standard Control Organisation is made in light of the looming threat of a yet-to-hit third wave, despite the country’s accelerated pace in administering vaccine doses to its adult population over the last few months.

Over 870 million doses have been administered to citizens over the age of 18, out of which over 631 million are first doses and the rest being second doses, it brings the total percentage of the population to receive at least one dose of vaccine to 46.2%. Now, as schools and colleges reopen, the government has turned its focus on immunising children below the age of 18 against COVID-19.

Serum Institute of India is not the first vaccine maker to receive a green light to conduct vaccine trials among children in India. Bharat Biotech had previously been granted permission to conduct trials for its Covaxin for use in the age group of 2 to 18 years. Currently, only Zydus Cadila’s ZyCov-D vaccine has received emergency use approval in India to be used in children aged 12 years and above.

Pune: Production of Covovax started at SII, shows 90.4 per cent efficacy

Aayushi Singh — Fri, 25 Jun 2021 16:12:15 +0000

The firm announced on Friday that the manufacturing of the first batch of Covovax vaccine has started at Serum Institute of India, Pune facility.

The company said that a new milestone had been reached, they began their first batch of Covovax at their facility this week in Pune.

Adar Poonawalla, CEO of The Serum Institute of India said that they were hoping to launch Novavax’s COVID-19 vaccine “Covovax” in India by September as the trials of the vaccine have been in advanced stage of completion.

Novavax announced in September 2020 about a manufacturing agreement with SII for it’s COVID-19 vaccine NVX-CoV2373. Poonawalla said that the trial of Novavax’s coronavirus vaccine in India was likely to conclude by November. He added that the pharmacy giant could apply for a vaccine license even before it’s trial concludes in the country on the basis of the global data of the trial.

On June 14, Novavax said in a statement stated that a vaccine candidate ’NVX-CoV2373’ demonstrated 100 per cent protection against the moderate and severe COVID-19 infection, the candidate showed 90.4 per cent efficacy overall, it also met the primary endpoint in its PREVENT-19 picotal Phase 3 trial.

The statement added that the study enrolled at least 29,960 candidates across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity of the vaccine.

Novavax said that the Covovax vaccine had showed 93 per cent efficacy against predominantly circulating variants of concern and the variants of interest.