Sputnik Light, J&J take another step towards joining India's COVID vaccine arsenal

In an affidavit dated 26 June, the Centre had told the Supreme Court that a total of 135 crore doses of COVID-19 vaccines will be made available to the citizens between August and December. In keeping with that goal, India has now taken a step that would not only help the country meet the target but is also likely to surpass it.

Around 35 lakh doses of Johnson & Johnson’s single-shot vaccine, manufactured in India by Hyderabad-based vaccine maker Biological E, have been dispatched for the final round of quality and safety checks at the country’s apex vaccine testing laboratory in Himachal Pradesh, as per News18.com.

"It will take around two to three weeks for testing at CDL (Central Drugs Laboratory)," said an official from the Ministry of Health and Family Welfare privy to the development.

Meanwhile, Russian COVID-19 vaccine Sputnik's single-dose jab Sputnik Light has received Drugs Controller General of India's (DCGI) nod to conduct phase-three bridging trials in India. The first tranche, manufactured by Panacea Biotec, has already been sent for quality and safety validation. Once the bridging trial is done the doses can be safely administered to the trial participants.

"While samples of Sputnik Light... have already been sent for quality, safety checks at the Central Drugs Laboratory in Kasauli, the hospitals have also been reached for setting the trial sites,” said a senior government official requesting anonymity. “The enrollment of participants for the trial is likely to start this week.”

So here's everything you need to know about the development:

What's the rule for clearance of foreign vaccines

As per the rules laid down by the health ministry on 13 April, coronavirus vaccines, which have been developed and are being manufactured in foreign countries that have been granted emergency approval for restricted use by the US's Food and Drug Administration (FDA), European Medicines Agency (EMA,) UK's Medicines and Healthcare products Regulatory Agency (MHRA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA) or which are listed in WHO (Emergency Use Listing) can be granted emergency use approval in India.

The mandatory requirement is of “post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019”.

Johnson & Johnson’s single-shot vaccine

The adenovector vaccine JNJ-78436735 or Ad26.COV2.S, which is similar to the Oxford-AstraZeneca vaccine, is 85 percent effective against “severe/critical disease and demonstrated protection against hospitalisation and death”, as per a study. On 7 August, the vaccine was approved for use in India by the Drug Controller General of India (DCGI), making it the sixth vaccine to get EUA after Covishield, Covaxin, Sputnik V, Moderna, and Zydus Cadila’s ZyCoVD.

Sputnik Light

Sputnik Light, the single-dose version of the Russian Covid-19 vaccine Sputnik V, has shown 93.5 percent efficacy. The vaccine was tested on 320,000 subjects. The subject expert committee (SEC) in July had told Dr Reddy’s Laboratories, custodian of brand Sputnik V, that it need not conduct a separate phase-III trials in India. The expert panel has said that data from the Russian phase-III trials would be enough to grant a marketing authorisation (MA) to the vaccine.

Progress Report

The cumulative doses administered in the country so far under the nationwide vaccination drive has reached 75.89 crore according to the health ministry. So far, 18 percent of adults have been double-jabbed and 58 percent are single-jabbed.

In June, the government had told the Supreme Court that 1.35 billion doses will become available between August and December. It wants the entire adult population covered by December. About 1.8 billion doses are needed to vaccinate all eligible adults in India.

With inputs from agencies