'Highly effective' against new variants, suitable for 12+: Pfizer seeks fast-track approval for its COVID-19 vaccine
New Delhi | Jagran News Desk: With India dealing with an acute shortage of COVID-19 vaccine, US pharmaceutical firm Pfizer on Wednesday once again sought fast-track approval for its vaccine, which it said has shown "high effectiveness" against the coronavirus varients prevailing in the country.
Pfizer, which was the first firm to seek emergency approval in India, told the government that its vaccine suitable for everyone above the age of 12 and can be stored for a month at 2-8 degrees. The vaccine maker further said that it is ready to supply five crore doses to India between July and October this year.
"The current situation in India, and across the world, is not ‘business as usual' and we must not respond to it with processes as usual too," news agency PTI quoted sources as saying.
PTI sources further said that Pfizer and the government have agreed to jointly work on three key issues -- procurement through a central government pathway, indemnity and liability and the regulatory requirement for post-approval bridging studies -- to accelerate approval for the company's COVID-19 vaccine in India.
"The timely alignment and execution of the draft Heads of Terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the Distribution and Supply Agreement," Pfizer told the government during the meeting.
Pfizer has said India should "rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study."
The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed.
It has also stated that the Pfizer vaccine has undergone significant development over the last six months which includes improvement in storage conditions at 208 degrees for over one month (31 days) at the site of vaccination.
"Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity," Pfizer has said.
Providing data, it said UK's Public Health England (PHE) has reported high vaccine effectiveness (87.9 per cent) against the B.1.617.2 variant, most reported in India, in an observational study (concluded on May 22, 2021).
It further said 26 per cent of study participants overall were of "Indian or British Indian" ethnicity, and also included Bangladeshi (1.4 per cent), Pakistani (5.9 per cent) and any other Asian background (5.7 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.
Also, the data from Qatar's nationwide immunization program demonstrated high vaccine effectiveness -– 89 per cent against B.1.1.7 variant (first detected in the UK) and 75 per cent against B.1.351 variant (first detected in South Africa).
It said 24 per cent of study participants were of Indian nationality (more than 6,000), and others included Nepalese (6-12 per cent), Bangladeshi (4-11 per cent), Sri Lankan (3-4 per cent), Pakistani (4-6 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.
Pfizer has urged the Government of India to rely upon WHO's testing pathways of reliance on testing certificates from country of origin instead of mandating local testing and batch release stating will also help fast track vaccine introduction and prevent vaccine wastage.
Pfizer has also shared the most recent data on BNT162b2 mRNA vaccine -- the phase 3 clinical trial showing vaccine efficacy six months after the second dose from the pivotal registration trial, as also for variants in vitro neutralization, clinically efficacy data and real-world vaccine effectiveness against emerging variants of SARS-CoV-2. The data shared with Indian authorities also include "real-world evidence of BNT162b2 vaccine effectiveness and safety from national immunization programmes".
The shared datapoints include trials showing nearly 95 per cent effectiveness against COVID-19, 100 per cent efficacy against severe disease and also 100 per cent vaccine efficacy in 12-15-year-old adolescents.
(With inputs from PTI)
Posted By: Aalok Sensharma