Despite the Centre's move to fast-track approvals for foreign-produced COVID-19 vaccines that have been granted the Emergency Use Authorisation (EAU) in other countries, Moderna and Pfizer may still take time to come to India.
While Moderna is 'not keen' to enter India, Pfizer's entry is conditional upon signing of an indemnity bond, ThePrint reported citing industry sources.
The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), in its meeting on April 11, recommended that vaccine candidates that have been developed and are being manufactured in foreign countries and which have been granted EUA by the US, Europe, UK, Japan or those listed in the World Health Organisation (WHO)’s emergency use list, maybe granted approval in India. This recommendation by the NEGVAC was accepted after due consideration, the Union Government had said.
According to the news report, American pharmaceutical giant Pfizer, which had earlier applied for emergency use authorisation in India, withdrew its application citing the central government's unwillingness to sign an indemnity bond. Signing an indemnity bond would protect the company from any legal action in case the vaccine causes any adverse reaction.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Pfizer has signed such indemnity bonds with every country where it has been supplying its COVID-19 vaccine and the discussion around pricing in India would begin only after the Centre agrees to sign the bond, the report suggested. However, the Union Government had said in an RTI response in January that it had no proposal to indemnify vaccine manufacturers.
“We have noted the recent announcement with regard to the regulatory pathway for global vaccines,” Pfizer told ThePrint.
“We remain committed to continuing our engagement with the (Indian) Government towards making the Pfizer and BioNTech vaccine available for use in the Government’s immunization program in the country," the company spokesperson was quoted as saying.
As for Moderna, the Centre for Cellular and Molecular Biology (CCMB), under the Council of Scientific & Industrial Research (CSIR) has reportedly been in discussions with the company to bring its vaccine to India.
“Despite talking with them for several months, the company was not really keen to bring its COVID-19 vaccine in India, probably because they have their hands full, right now. But with this new announcement coming in, the Indian government via CSIR may start pushing them again,” a senior CSIR official told the news portal.
Moderna also listed supply agreements of orders with countries including the United States, Canada, South Korea, Japan, Switzerland, Colombia, Israel, Taiwan, Singapore, Qatar, and the European Union, among others, which totals to over one billion doses.
Meanwhile, Johnson and Johnson (J&J) has reportedly begun talks with the Indian authorities for bridging trials and approval of its jab. However, the vaccine has been paused in the US for at least a few days on the recommendation of the US Food and Drug Administration (USFDA) following the development of rare blood clots in few recipients.Click here for Moneycontrol’s full coverage of the coronavirus pandemic