Pfizer vaccine in final stages of getting approval in India
Pfizer’s coronavirus vaccine is said to be in the final stages of getting approval in the country. The pharma giant expects to finalise an agreement with the Indian government soon.
Pfizer, which developed the vaccine in partnership with the German firm BioNtech, employed the revolutionary messenger-RNA (mRNA) technology for the shot and it has a very high efficacy of over 90 per cent in preventing the infection.
“Pfizer now in final stages to get approval for coronavirus vaccine in India. I hope very soon we will finalise an agreement with the govt,” its chief executive officer Albert Bourla said.
The Indian government is engaged with Pfizer for quite sometime now to bring the shot to the country, but both parties are reportedly stuck on the issue of granting indmenity to the firm.
The Pfizer-BioNTech shot has been approved by the US Food and Drug Administration (FDA), and other western regulators for emergency use. The vaccine is also authorised for use in teens in the US.
Reports earlier stated that US major Pfizer has told Indian authorities that its jab has shown “high effectiveness” against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality, while it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees.
Pfizer, which is ready to offer 5 crore doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with the Indian government authorities recently including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO).
The Pfizer CEO said that a significant local manufacturing of vaccines that is happening at the Serum Institute of India will provide the backbone of vaccinating the Indian people.
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Pfizer Covid vaccine induces ‘good’ immune response against coronavirus variants
Two doses of the Pfizer COVID-19 vaccine induce a “very good” antibody response against the SARS-CoV-2 variants, according to a study on 180 health care workers in Finland.
The research, published in the journal Nature Communications, found that the immune response was as strong against the Alpha variant first identified in the UK, as against the original virus found in Wuhan, China in 2019.
The immune response was somewhat decreased against the Beta variant first found in South Africa, but the vaccine generated neutralising antibodies that give relatively good protection against the variant. – PTI
Despite reminders by DCGI, Pfizer yet to apply for license for its COVID-19 vaccine in India: Reports
Indian drug regulator has urged Pfizer twice in writing to apply for emergency use authorization for its COVID vaccine so that application is processed well in time but Pfizer has not applied for the license yet: Sources
- Moderna’s Covid vaccine has become the 4th one to get emergency use approval in India.
- Pfizer is in final stages of approval for COVID-19 vaccine in India, CEO Albert Bourla had said in June.
- At present, Covishield, Covaxin and Sputnik V vaccine doses are being administered in India.
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Pfizer Inc is yet to apply for procuring license for launching its COVID-19 vaccine in India, sources said on Tuesday. Reports said that the Drugs Controller General of India (DCGI) has twice written to the US pharma giant to apply for emergency use authorization for its COVID vaccine so that application is processed well in time, but Pfizer has not applied.
The development comes days after AIIMS Director Dr Randeep Guleria informed that the talks between Pfizer and the government are in the final stages and an agreement would be finalised soon.
“Pfizer is negotiating as far as the various clauses are concerned and they are very close to reaching an agreement with the government. Once that is done then we will shortly be able to have these vaccines in our country. Negotiation with the company is going on. I am sure they are reaching the final stage now,” Guleria had said.
If the reports regarding Pfizer are true, then it comes a huge blow to the COVID-19 vaccination drive in India which is already hit by the shortage of vaccine doses.
Notably, in June, Pfizer CEO Albert Bourla had said that the company is in the final stages to get approval for the COVID-19 vaccine in India.
According to a study published in The Lancet Infectious Diseases, a single dose of Pfizer vaccine offers around 60 per cent protection against infection from SARS-CoV-2 in adults aged 65 years and above.
Pfizer to seek OK for 3rd vaccine dose; shots still protect
Pfizer is about to seek US authorisation for a third dose of its COVID-19 vaccine, saying that another shot within 12 months could dramatically boost immunity and maybe help ward off the latest worrisome coronavirus mutant.
Research from multiple countries shows the Pfizer shot and other widely used COVID-19 vaccines offer strong protection against the highly contagious delta variant, which is spreading rapidly around the world and now accounts for most new U.S. infections.
Two doses of most vaccines are critical to develop high levels of virus-fighting antibodies against all versions of the coronavirus, not just the delta variant — and most of the world still is desperate to get those initial protective doses as the pandemic continues to rage.
But antibodies naturally wane over time, so studies also are underway to tell if and when boosters might be needed. – AP
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