DCGI accords conditional market approval for Covaxin and Covishield

Firms will need to submit data of overseas ongoing clinical trials of their vaccines every 6 months

The Drugs Controller General of India (DCGI) has given its nod to the market authorisation of two Covid vaccines - Bharat Biotech's Covaxin and Serum Institute of India's (SII's) Covishield - for use in the adult population, subject to certain conditions, said a Union health ministry statement on Thursday. The approval, it said, reflects India’s proactive and agile Covid management. The approval was granted under the New Drugs and Clinical Trials Rules, 2019.

Both biotechnology companies will have to submit the data of the overseas ongoing clinical trials of their vaccines with due analysis every six months or as and when available, whichever is earlier.

Even with market approval, all vaccinations within the country will have to be recorded on the CoWIN platform. Any adverse event following immunisation (AEFI) and adverse event of special interest (AESI) should continue to be monitored.

The safety data of such events, including AESI and AEFI, has to be furnished by the companies to the drug regulator on a six-month basis, unlike the current practice of every fortnight, under the emergency-use guidelines. 

Commenting on receiving conditional market authorisation, Adar Poonawalla, chief executive officer, SII, said, "We are delighted to receive the conditional market authorisation for Covishield from the DCGI. With this, our focus should be to reduce the gap between the second and the third dose to six months, as it is done globally. Our objective must be to get the population fully vaccinated to curb the spread of the pandemic."

India has vaccinated 95 per cent of its adult population with a single dose and 74 per cent with both doses. In contrast, only 3 per cent of the adult population was fully vaccinated when India was hit by the second wave of the pandemic, triggering more than 414,000 daily cases and 3,679 deaths, according to the health ministry data. 

Precaution doses for health and front-line workers, along with those above 60 years of age, are underway, as is the vaccination drive for the 15-17-year age group. 

The subject expert committee of the Central Drugs Standard Control Organisation had recommended upgrading the status of the vaccines from restricted use in emergency situations to granting of new drug permission with conditions in the adult population on January 19. 

The government has not shared any details on the pricing of the two vaccines yet. “The latest approval accorded by the DCGI for conditional market authorisation to the two Covid vaccines in the country indicates the promptness and timeliness with which the public response strategy and decision-making apparatus of the country has responded to the emerging needs during the pandemic,” the health ministry said in its statement.

It noted that only the US Food and Drug Administration and the UK's Medicines and Healthcare products Regulatory Agency have granted “conditional market authorisation” to Pfizer and AstraZeneca, respectively, for their Covid vaccines. 

According to the ministry, 'conditional market authorisation' is a new category of market authorisation that has emerged during the current global pandemic. "The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines," it said.

The health ministry also said that Omicron has become the dominant variant in the country in January. Sunil Singh, director, National Centre for Disease Control, said there was a sharp surge in Omicron cases which made up 75 per cent of the samples sequenced in January. “It is not true that we are seeing only the Omicron variant. Delta is still present in the country. The clinical severity is also due to Delta. Cases coming to hospitals should not be considered as pure Omicron and therefore, of low severity,” he said. 

More than 90 per cent of the active cases are under home isolation presently. “The active case numbers and corresponding deaths are much lower during the present surge vis-à-vis the earlier surges. Vaccination is helping in terms of fewer cases, fewer hospitalisations, and less severity of cases being reported in the country,” said Lav Agarwal, joint secretary, health ministry.

Conditions apply:

• Companies have to submit ongoing clinical trial data

• Safety data, AEFI of the vaccines to be strictly monitored

• Both data to be shared at a longer interval of six months.

Vaccination coverage:

• 95% adults - 1st dose

• 74% adults - 2nd dose

• Precaution Dose: 9.7 million

Source: Health ministry.