New Delhi: American pharmaceutical giant Pfizer said Tuesday that its Covid-19 vaccine has the potential to be an important part of India’s early immunisation response against the pandemic.
Experimental vaccine shots developed by Pfizer, along with German biotechnology firm BioNTech SE, have shown more than 90 per cent efficacy in stopping SARS-CoV-2 infections, the companies announced Monday.
Since the announcement, the mRNA technology-based vaccine has taken the lead in the race for a Covid vaccine, and brought some semblance of relief amid the raging pandemic.
In India, the number of active Covid cases is hovering around 5 lakh, with a total death toll of over 1.27 lakh.
In an emailed response to questions from ThePrint, a Pfizer spokesperson said: “We believe that with the scale (of vaccine doses) required in India, it can be expected that there may eventually be multiple vaccines deployed in the country. However, if successful, Pfizer’s Covid-19 vaccine certainly has the potential to be an important part of India’s early vaccine response to the pandemic in priority geographies and populations.”
While the company highlighted that initially the potential vaccine will need to be stored at minus-75 degrees Celsius (plus-minus 15 degrees), it has made solutions to overcome this problem for countries with weaker storage infrastructure.
“We have experience working with customers in all markets and have developed comprehensive solutions to partner with countries to help in the deployment of this vaccine,” Pfizer added.
‘Final efficacy percentage of vaccine may vary’
An early analysis of data from the phase 3 trial of more than 40,000 volunteers indicated that the Pfizer-BioNTech vaccine shots were more than 90 per cent effective in preventing Covid.
After discussion with the US Food and Drug Administration during the global phase 3 study, Pfizer and BioNTech had an evaluable case count of 94 infections, and an independent Data Monitoring Committee then performed its first analysis on all the cases, the company said.
“The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate (of) above 90 per cent, at seven days after the second dose,” the spokesperson said.
“This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule. As the study continues, the final vaccine efficacy percentage may vary.”
The data will soon be made public and will undergo peer-review, the process of evaluation by competent professionals.
“Pfizer and BioNTech plan to submit the full efficacy and safety data from our phase 3 trial for peer-review in a scientific journal once the data from the accrued 164 cases is complete and analysed,” the emailed response stated.
US, Europe to manufacture vaccine in first phase
Asked about the company’s plans to supply its potential vaccine to low and middle-income countries, including India, the Pfizer spokesperson replied: “At this time, our priority is to ensure rapid manufacturing and deployment of the vaccine to cater to a pandemic response scenario.
“We are also mindful of the unique mRNA technology that is being utilised in this vaccine. Given these considerations, Pfizer has created two dedicated supply lines with established vaccine capabilities — one each in the US and Europe — to exclusively manufacture this vaccine for use across the world.
“Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will evaluate all additional opportunities available.”
In October, Russia’s sovereign wealth fund – Russian Direct Investment Fund — had partnered with Hyderabad-based Dr Reddy’s Laboratories to cooperate on clinical trials and work on the distribution of that country’s Sputnik V vaccine in India.
British-Swedish pharma giant AstraZeneca has also signed an agreement with the Pune-based Serum Institute of India to produce the Oxford University vaccine on a mass scale.