India’s COVID vaccines: A primer

With vaccine rollout beginning January 16, India’s battle against COVID-19 progresses to the next stage. Here’s all you need to know about the country’s efforts towards mass vaccination.

On January 2, India approved two vaccines for emergency public rollout. Following the nod from the Subject Experts Committee (SEC) and Drug Controller General of India (DCGI), the huge task to inoculate 1.3 billion people is all set to begin on January 16.

With the two vaccines approved and ready for deployment, India joins the list of countries that have begun COVID vaccination.

What are the vaccines?

Currently, two vaccines have been granted approval for emergency use. Both of these are administered in the form of intramuscular injections across two doses, spaced 28 days apart.

• Covishield: Developed by Oxford University and AstraZeneca
• Covaxin: Developed by Bharat Biotech

While Covaxin is developed and manufactured entirely in India, global partnerships for the Oxford vaccine mean that its India demand will be met entirely through the mass production facilities of Serum Institute of India.

In addition to the two approved vaccines, India also has seven other candidates currently in various stages of trials. The Pfizer and Moderna vaccines that have seen massive public rollout across the US, EU & UK have not made their way into India yet.

What does approval for emergency use mean?

The US FDA defines Emergency Use Authorisation (EUA) as “a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.”

When and how do I get the shot?

India’s rollout is slated to begin January 16. The plan prioritises 300 million people in phase 1 – starting with approximately 10 million healthcare workers, followed by 20 million frontline workers, and then the population group of 270 million comprising people aged over 50 years and those under 50 with co-morbidities. Electoral rolls will be used to identify these target groups.

Just days prior to granting approvals, operational guidelines were released for mass vaccination. Outlining activities across “multilevel governance mechanisms”, the guidelines also call for “intersectional convergence” with different ministries and nodal bodies tasked with their role.

COVID-19 Vaccine Intelligence Network (Co-WIN) has also been developed as a digital platform with:

• the website (www.cowin.gov.in) to be used by the National, State and District Level administrators, and
• the Co-WIN app, for registration and verification of individual

Self-registration via the app is not allowed in phase 1 of rollout. It will be “available in the later phases of implementation”. Currently in pre-product stage, the app will be available both on the App Store and the Play Store.

What happens after I get the shot?

Most COVID-19 vaccines, including the ones approved in India, require two doses. Immunity in the recipient does not develop instantly. It only starts to develop within 14 days of the second dose.

Vaccines protect from disease, not from infection. Even after getting vaccinated, one can get infected, but the infection will not induce the disease in the body. Speaking to Health Analytics Asia, noted virologist Dr. Shahid Jameel said, “The end point of vaccine testing has been efficacy against disease. No vaccine claims that it will stop transmission.” An infected (non-diseased) person can still infect others. Maintaining precautions, including the wearing of masks, is strictly advised even after being vaccinated.

Are the vaccines safe?

“The advantage of these vaccines is that since there is no live virus, these are safe vaccines,” notes Dr. Jameel. Safety has also been established through their phase 1 and 2 trials. Prime Minister Narendra Modi called the approval of Covaxin as a “game-changer”. Union health minister Dr Harsh Vardhan said it was a “Monitored Approval” and that the “clinical trial mode” would mean that all vaccine recipients will be tracked as if they are in a trial.

COVAXIN approval is ‘Monitored Approval’ with strict follow-up & rolling review

This approval ensures India has an additional vaccine shield in its arsenal esp against potential mutant strains in a dynamic pandemic situation –
A strategic decision for our vaccine security ✔️ pic.twitter.com/TgP7BZNWHf

— Dr Harsh Vardhan (@drharshvardhan) January 3, 2021

However, concerns have been expressed over the haste in authorizing a vaccine without due assessment of data. While Covishield has completed its trials and submitted data to the SEC, Bharat Biotech is yet to reveal data from the third phase of Covaxin’s trials. “Efficacy is yet to be demonstrated,” reveal SEC documents available with Health Analytics Asia.

Dr. Faheem Younus, Chief of Infectious Diseases at the University of Maryland, called it a “risky strategy to start vaccinating a population without scientifically published phase 3 trials showing safety and high efficacy.” This data for Covaxin is not expected for another three months.

India: Vaccines are about safety, efficacy, and trust.

It’s a risky strategy to start vaccinating a population without scientifically published phase 3 trials showing safety and high efficacy. True for any country. Any vaccine.

Vaccine Nationalism is dangerous. https://t.co/tAMkh1LgwA

— Faheem Younus, MD (@FaheemYounus) January 4, 2021

Virologist and vaccine scientist Dr. Gagandeep Kang expressed her reservations too. Speaking to The Hindu, Dr. Kang was quoted as saying, “I would not take the vaccine without efficacy data, because it makes no sense to me.”

Evidently, Covaxin was granted approval only on the basis of Bharat Biotech’s claim that their vaccine will be effective against mutant strains – because it is of a ‘whole virus’ type of vaccine. Dr. Jameel, however, finds this reasoning flawed “simply because there is no data at this time”.

Bharat Biotech has responded to critics through a press conference to address concerns. Chairman Dr. Krishna Ella claimed this is not the first time a vaccine has been granted emergency use without efficacy data, citing a 2019 notification giving similar leverage for its typhoid vaccine.

In an attempt to settle the dust, and not let political tussle muddle up the work of scientists, Bharat Biotech and SII, through a joint statement on January 5, have pledged for a smooth rollout of vaccines “to India and the world”.

Important Announcement: Joint statement @BharatBiotech and @SerumInstIndia pic.twitter.com/la5av27Mqy

— SerumInstituteIndia (@SerumInstIndia) January 5, 2021

End of ordeal?

India may have dealt with the worst of the pandemic, but the battle is far from over. As fresh cases still average above 15,000 a day, the next phase of this pandemic unfolds – mass vaccination. With a queue of over 1.3 billion people, India needs all hands on deck.