The UK's medicines regulator on Friday approved the Pfizer/BioNTech coronavirus vaccine for 12 to 15 year olds.
According to the organisers, based on the feedback from the NOCs and NPCs, it is expected that a significant proportion of Games participants will have been vaccinated before arriving in Japan. The new MoU adds to these efforts.
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralising antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.
After discussion with the Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, the statement said.
The study also shows that levels of these antibodies that are able to recognise and fight the virus are lower with increasing age, and that levels decline over time, providing additional evidence in support of plans to deliver a booster dose to vulnerable people.
After Brihanmumbai Municipal Corporation Commissioner Iqbal Singh Chahal claimed that Mumbai has received a bid from Pfizer in response to its COVID-19 vaccine procurement tender, Pfizer issued a statement clarifying that it has made no such bid.
Researchers at Public Health Scotland and the University of Edinburgh, UK, found that the Pfizer-BioNTech vaccine offered better protection against the Delta variant compared to the Oxford-AstraZeneca preventive, known as Covishield in India.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
Pfizer sought to participate in the Subject Expert Committee consultations towards an emergency use authorisation for its Covid-19 vaccine. However, the company representatives have been unable to participate in the meetings because of extremely short notices of a few hours or less and time-zone limitations.
According to The New York Times, this move means that many highly vulnerable people will begin receiving the vaccine within days. It further called the authorisation by the FDA as a 'historic turning point' as the US death toll from the Wuhan-originated virus nears 300,000.
Health officials have previously raised the possibility that the public may need booster COVID-19 shots.
The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
India's first mRNA platform-based vaccine will remain stable at 2-8 degrees Celsius while Pfizer-BioNTech's vaccine needs minus 70 degrees Celsius and Moderna vaccine can remain stable for six months at minus 20 degrees Celsius, reports Sohini Das.
The United Kingdom on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, paving the way for mass vaccinations against the deadly novel coronavirus.
The researchers analysed 2580,021 test results from nose and throat swabs taken from 384,543 participants aged 18 years or older between December 1, 2020 and May 16, 2021.
Initial data has shown immunity triggered by the two mRNA vaccines -- Pfizer-BioNTech and Moderna -- lasts for at least six months
The WHO said the four current 'Variants of Concern' being monitored closely - Alpha, Beta, Gamma and Delta - are widespread and have been detected in all WHO regions.
Maggie is among the first set of people contacted in advance by the NHS for the jab based on a pre-determined health risk criteria and will include 87-year-old British Indian grandfather of nine Hari Shukla, who will get his first dose at a hospital in Newcastle.
At $37 per dose, the Pfizer vaccine is much more expensive compared to $3 per dose for the Covishield.
The warning comes after two National Health Service (NHS) workers experienced 'anaphylactoid reaction' symptoms shortly after being injected, but are now said to be recovering well.
Pfizer's chief executive Dr Albert Bourla told the BBC that he is of the view that annual vaccinations would be needed to maintain a "very high level of protection" against the deadly disease that has claimed over five million lives across the world.
According to the study, 'mixed' schedules of these vaccines induced high concentrations of antibodies against the SARS-CoV2 spike IgG protein when doses were administered four weeks apart.
Biden previously told Jake Tapper of CNN that he would be "happy to" take the COVID-19 vaccine once US infectious disease expert Anthony Fauci said it was safe and he would get the injection in a public setting to prove it.
Guterres reiterated his call for a COVID-19 vaccine to be a global public good available to everywhere and particularly, available in Africa.
The US vice-president-elect received a dose of the Moderna vaccine from clinical nurse Patricia Cummings at United Medical Center, which is located in Southeast Washington, DC.
The news comes as the United States approaches 300,000 deaths from COVID-19.
Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
Hari Shukla from Tyne and Wear said he feels it is his duty to receive his first of the two-dose vaccine, a moment UK Prime Minister Boris Johnson hailed as a "huge step forward" as Tuesday was dubbed "V-Day" or Vaccine Day in the UK.
Following up first doses of the AstraZeneca or Pfizer vaccines with second doses of the Moderna or Novavax jabs generates robust immune response against COVID-19, according to a study published in The Lancet journal.
Pfizer and BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy endpoints.
The Drugs Control General of India has permitted emergency use of Covid vaccine Sputnik V with certain conditions, clearing the way for a third vaccine in addition to Covishield and Covaxin. Besides, the government on Tuesday also fast-tracked emergency approval for other jabs. Here is what the vaccines are all about:
The Medicines and Healthcare Regulatory Agency, which had been formally tasked by the UK government last month with the process of clearance after the jab emerged "safe and effective" against the novel coronavirus in human trials, is expected to authorise the vaccine by December 28 or 29 after the final data is provided on Monday, 'The Daily Telegraph' quoted senior government sources as indicating.
The protection gained after being fully vaccinated with both doses of the Pfizer/BioNTech and Oxford/AstraZeneca vaccines against Covid-19 wanes over time, a new UK study reported on Wednesday.
The South African Health Products Authority (SAHPRA) on Wednesday approved the use of Pfizer's Comirnaty COVID-19 vaccine after BioNTech and Pfizer announced that two doses of their vaccine may not be enough to protect against the Omicron variant.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said Zydus Cadila, Sputnik V, Biological E and Gennova are other vaccines also in the pipeline which are in advanced clinical trials in India.
This means that half of adults are cleared under CDC guidelines to not wear a mask in most indoor and outdoor settings.
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