- In order to carry out its vaccine in India, Pfizer wants legal protection from claims of adverse events.
- Pfizer also said that their vaccine has been proven safe for those over the age of 12 and can be kept for a month in cold storage facilities between 2°-8° C.
- The Pfizer-BioNTech COVID-19 vaccine is 95 per cent effective at protecting against the virus.
According to sources, Pfizer has informed the government that their Covid vaccine is “very efficient” against the India-dominant variant of the virus that doctors believe is responsible for the disastrous second wave of infections and fatalities in the country.
According to sources, Pfizer also assured the government that their vaccine had been shown safe for those over the age of 12 and that it could be stored in cold storage facilities with a temperature range of 2-8 degrees Celsius for a month.
The American pharmaceutical behemoth is negotiating with the government for a fast-track clearance to distribute five crore doses between July and October if it receives significant regulatory relaxation, such as indemnity, or protection against compensation claims in case of adverse events.
Over the past few weeks, the two sides have held a series of discussions to settle issues, some of which included Pfizer Chairman and CEO Albert Bourla to resolve issues including the grant of legal indemnity.
Covishield, Covaxin, and Sputnik V, the three vaccines currently licenced for use in India, have not been given such protection. Pfizer has insisted on it, and other countries that use the drug, notably the United States and several European countries, have agreed.
According to sources quoted to PTI, the Indian government should “rely on the 44 authorizations, including WHO permission, to allow emergency usage authorization…”
The company, on the other hand, is willing to consider surveillance of the first 100 people who receive the vaccination.
According to sources, Pfizer has provided the most recent data points about trials, efficacy rates, and approvals from various countries and the World Health Organization (WHO).
These include data from Public Health England in the United Kingdom, which found that the Pfizer vaccination provided 87.9% protection against the B.1.617.2 strain detected in India in an observational trial. The ethnicity of 26% of research participants was “Indian or British Indian.”
Other important factors in speeding authorization for the Pfizer vaccine include procurement via a central government pathway and regulatory requirements for post-approval bridge studies.
Last week, the Delhi government approached Pfizer (and Moderna, another US pharma giant with a Covid vaccine) in the hopes of directly purchasing vaccinations from them. Pfizer turned down the offer, citing company policy as the reason for dealing only with the central government.
Moderna highlighted similar policies as a reason for refusing the Punjab government.
India has given out over 20 crore vaccine doses so far, but it is still far from vaccinating a substantial chunk of its 130-crore population.
A scarcity of vaccine doses is thought to be one of the main causes of the recent slowdown, with numerous states reporting insufficient inventories and suspending vaccination for people aged 18 to 44.
Covishield (made by the Serum Institute) and Bharat Biotech’s Covaxin are currently available in India.
A third vaccination, the Russian-made Sputnik V, will be available soon.
None of these have been approved for use in children under the age of 18, however Covaxin expects to begin studies for the 2-18 age range by the end of the month.
Children and young adults, who some experts believe may be the focus of the third wave, accounted for less than 10% of new cases this month, but weekly numbers did show a steady rise.