Pfizer Found to be Safe for Children and Effective Against Indian COVID Variant, Seeks Fast-Track Clearance from India

Pfizer "Highly Effective" Against Indian COVID Variant, Safe for Children, Seeks 

Pfizer, an American pharmaceuticals company, has advised Indian authorities that its Covid-19 vaccine has shown "high effectiveness" against a novel coronavirus strain found in India, as well as on people of Indian ethnicity or nationality. 

Pfizer has also stated that their vaccine is safe for those aged 12 and up and that it may be stored for a month at 2-8 degrees Celsius, according to sources. 

"Recent data points confirm the high effectiveness of BNT612b2 (as the Pfizer-BioNTech vaccine is technically known) 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity," Pfizer has said.

According to the report, 26% of participants in recent observational research conducted by Public Health England (PHE) in the United Kingdom were of "Indian or British Indian" ancestry. Pfizer notifies the government that 26 percent of the participants in a UK research that demonstrated great effectiveness were of Indian ethnicity. 

This study, which concluded on May 22 showed the vaccine effectiveness against the B.1.617.2 strain, which is most commonly reported in India, to be 87.9%.

Bangladeshis (1.4%), Pakistanis (5.7%), and those from any other Asian heritage (5.7%) were among the 26% Indian or British Indian study participants, showing that the observed vaccine effectiveness applied to these groups as well. 

Pfizer also stated that data from Qatar's nationwide immunization program revealed strong vaccine effectiveness of 89% against B.1.1.7 (first detected in the UK) and 75% against B.1.351 (first found in South Africa). 

It stated that 24% of the participants in this study were Indian (more than 6,000), Nepalese (6-12%), Bangladeshi (4-11%), Sri Lankan (3-4%), and Pakistani (4-6%) implying that the vaccine effectiveness is seen in this study also applies to these groups.

Pfizer has requested various concessions, including indemnification, in hopes of selling 5 million doses of its vaccine to India between July and October this year. It has met with Indian government officials numerous times recently, most recently this week, and presented the most up-to-date data on effectiveness studies and vaccination approvals in other nations. 

"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," a source quoted Pfizer as having communicated to the Indian government.

Following recent talks between the Indian government and Pfizer Chairman and CEO Albert Bourla, the two sides have agreed to engage on three key points in order to expedite clearance for Pfizer's Covid-19 vaccine in India: procurement through a central government channel, indemnity, and liability, and the regulatory requirements for posing.

India is actively inoculating its populace using Serum Institute of India's Covishield and Bharat Biotech's Covaxin vaccines, as well as small volumes of Russian-made Sputnik V vaccinations.

Pfizer has commended the Government of India for agreeing to its request for procurement through a central government pathway and for discussing "the Indemnity and Liability protection" in its most recent correspondence to the government.

"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," the company told the government.

The company is seeking that the regulatory process be expedited so that it can supply India "as expeditiously as possible."

The US, which is the worst COVID-19 hit nation in the world, has successfully inoculated over six lakh children between the ages of 12-15. 

Meanwhile, Bharat Biotech was granted authorization to start a Phase 2/3 clinical trial of Covaxin in children aged 2 to 18 years old earlier this month. According to sources at the Hyderabad-based vaccine manufacturer, the inoculation drive will begin in June. 

Also Read - Fugitive Indian Billionaire Mehul Choski Arrested in Dominica

Also Watch - Rangia police bust drug racket, one arrested