Covovax vaccine samples cleared by national drug lab, phase 3 trials could begin by July

Covovax, Novavax's Indian version, will be tested on 1,400 volunteers across 20 cities by Serum Institute, which has already begun production of the Covid vaccine.

Covovax has been developed by Novavax Inc., which is headquartered in Gaithersburg, Maryland, USA | Representational image: Al Drago | Bloomberg

New Delhi: For the upcoming phase 3 trials, shots of Covovax vaccine — the Indian version of the vaccine originally developed by the US-based Novavax Inc. — have been released by the Central Drugs Laboratory (CDL) in Kasauli, ThePrint has learnt.

Covovax is the second Covid-19 vaccine being manufactured by Pune-based Serum Institute of India (SII). The pharma company also manufactures the Indian version of the AstraZeneca-Oxford University’s vaccine, Covishield.

The country’s apex vaccine testing laboratory, CDL in Himachal Pradesh (Kasauli) — which is responsible for testing the quality of all vaccines used in the country, including Covid-19 vaccines — has submitted its final report approving Covovax’s batch to the Drug Controller General of India (DCGI).

“The laboratory had earlier released the batches of Covovax in February, this year, after which the company started phase 2 trials in March. Received in May, CDL has now released the latest batch which will be used in the phase 3 trials,” a government official privy to the development told ThePrint.

Covovax’s phase 3 trial likely to start by next month

According to industry sources, the last stage trial is expected to kickstart by July.

“The trials were expected to start by mid-June but now they may start by the next month,” a source said.

In February, DCGI had approved SII’s proposal to conduct a phase 2 and 3 bridging study.

This study is conducted to prove that a vaccine is similar to the original version. Such trials involve a small number of participants to generate data on safety and immunogenicity and not a large efficacy study.

In India, under the phase 3 trials, Covovax will be tested on 1,400 volunteers above 18 years of age across 20 sites in the country.

Novavax’s data promising, SII already stockpiling Covovax

Vaccine maker Novavax Monday announced that its vaccine was about 90 per cent effective overall and preliminary data showed it was safe.

Based on the data, Dr V.K. Paul, Niti Aayog member (health), Tuesday said that the declared efficacy data by the company is “promising” and the vaccine will soon be made in India by SII.

ThePrint had reported in May that the health ministry had given SII the go-ahead to manufacture and stockpile Covovax vaccine. SII has already begun the production of Covovax.

(Edited by Manasa Mohan)