India announces COVID-19 vaccine roll out, amps surveillance for new strains

Accelerating approval for two COVID-19 vaccines, India announced it will roll out a mega immunisation drive within the second week of January 2021 to check the spread of the pandemic in one the worst-hit countries of the world.

The government conducted a dry run in select hospitals across the country to critically evaluate logistics for the vaccination roll out. Around 300 million frontline workers are expected to get the vaccine dose in the first phase, scheduled to begin on 13 January 2021.

"Based on the feedback of the dry-run, (the) Health Ministry is ready to roll out COVID-19 vaccine within 10 days of date of emergency use authorisation," India's health secretary Rajesh Bhushan announced in a press conference today.

The fast-track approval for two vaccines came on 3 January 2021 - Oxford-AstraZeneca's vaccine, being manufactured by Serum Institute of India under the brand name Covishield; and Covaxin, by Indian company Bharat Biotech in collaboration with two government-backed institutes (the Indian Council for Medical Research and National Institute of Virology, Pune). Of these, Covaxin is still in phase three trials, and its approval fuelled questions on its efficacy. The government sought to quell these fears calling it a ‘back-up vaccine’ only to be put to use in case of a spurt in infections from potential mutant strains.

Director of the All India Institute of Medical Sciences Randeep Guleria told Nature India that the vaccines were cost effective and easy to administer. Both vaccines will require two doses but are cheaper than the global front runners – the Pfizer and Moderna vaccines – and do not require extremely low temperatures for storage, he said.

After the approval announcement, Adar Poonawalla, CEO of Serum Institute of India, tweeted, “All the risks the Serum Institute took with stockpiling the vaccine have finally paid off. Covishield, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.” Bharat Biotech managing director Krishna Ella said the company’s vaccine was safe and was being trialled in more than 12 countries. “Covaxin is 200% safe. We have tremendous experience in vaccines,” news agency ANI quoted Ella as saying. Together, Poonawalla and Ella also issued a statement jointly pledging to provide global access to their COVID-19 vaccines.

Vaccine experts were taken aback by India’s nod to Covaxin even before data from phase three trials was available. The Drug Controller General of India (DCGI) V G Somani, however, said the trials for the first two phases of Covaxin demonstrated that the vaccine was safe. However, his office has not publicly shared any efficacy data.

Vice chair of the Coalition for Epidemic Preparedness Innovations (CEPI) Gagandeep Kang said that both vaccines were made by companies well known for the quality of their products, and safety and efficacy of the AstraZeneca vaccine could be inferred from available data.

India’s Health Minister Harsh Vardhan said the nod for Covaxin was a ‘monitored approval’ with strict-follow up and rolling review. “This approval ensures India has an additional vaccine shield in its arsenal especially against potential mutant strains.” The emergency use approval for Covaxin is different from Covishield because its use will be in clinical trial mode. “All Covaxin recipients will be tracked, monitored as if they’re in trial,” Vardhan said.

Kang said although more number of participants have contributed towards safety and immunogenicity for Covaxin, efficacy data for this product is not yet available. "The basis for the ‘restricted use’ and ‘backup’ vaccine are, therefore, unclear,” Kang, a Professor at the Christian Medical College, Vellore, said.

Surveillance for new strains

In the backdrop of the emergence of a newly identified variant of the novel SARS-CoV-2 virus in the UK, South Africa and some other parts of the world, India accelerated its virus surveillance, genome sequencing and characterisation initiatives. The Indian SARS-CoV-2 Genomic Consortia (INSACOG) was kicked-off around the year-end with 10 laboratories to monitor the genomic variations in the virus. Besides assisting in the development of potential vaccines in the future, the consortium will ascertain the status of the new variant in the country, establish sentinel surveillance and determine genomic variants in unusual events.

Anurag Agarwal, director of the Institute of Genomics and Integrative Biology (IGIB), one of the CSIR labs sequencing SARS-CoV-2 genomes, told Nature India that the new UK variant appears to be more transmissible but interventions such as wearing masks and distancing would still be effective in reducing transmission. "There is no evidence yet of the new variant being more severe," he said.

Agarwal said some Reverse Transcription-Polymerase Chain Reaction (RT-PCR) kits may give false negative results for the crucial S gene of the new variant. “But since most kits in India use two genes or at least two regions to detect the presence of the virus, the other gene would still be positive.” Therefore, there is no reason to worry about missing cases at this time due to this new variant, he said.