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Latest from food and drug administration

US drug regulator postpones meeting on infant Covid vaccines

  • The meeting would have evaluated whether two doses of the Covid-19 vaccine shot should be authorised for children aged six months through four years, even though clinical trials are still evaluating whether three shots are needed.
Interim results in fact had shown that a low dose of three micrograms of Covid-19 vaccine given across the age group of six months to four years to stave off side effects did not elicit an immune response comparable to older age groups given a higher dose.(REUTERS Representative)
Interim results in fact had shown that a low dose of three micrograms of Covid-19 vaccine given across the age group of six months to four years to stave off side effects did not elicit an immune response comparable to older age groups given a higher dose.(REUTERS Representative)
Published on Feb 12, 2022 12:55 AM IST
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AFP |

US FDA clears Pfizer's Covid-19 booster shot for 12- to 15-year-olds

The FDA said it reviewed published data and real world evidence on the safety of booster doses provided by the Israeli Ministry of Health including data from over 6,300 individuals 12-to-15 years of age who received a Pfizer shot.
Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while boosters appear to be protective against the highly-mutated variant.(AP)
Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while boosters appear to be protective against the highly-mutated variant.(AP)
Published on Jan 03, 2022 08:28 PM IST
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Reuters |

In a first, US approves AstraZeneca antibody for cases reacting badly to vaccine

The FDA warned the drug Evusheld is “not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended” and can only be authorized for people who have a weakened immune system or those who cannot be vaccinated for medical reasons, such as a strong allergic reaction.
The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, US. (REUTERS)
The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, US. (REUTERS)
Published on Dec 09, 2021 07:21 AM IST
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AFP |

Pfizer, Moderna booster shots cleared for all US adults. Final hurdle remains

According to the CDC, more than a third of fully vaccinated senior citizens in the US had already received their booster doses as of Thursday, and 17 per cent of fully vaccinated adults overall have had an additional shot of vaccine.
US regulators have opened up Covid-19 booster shots to all and more adults on Friday. (File Photo / AP)
US regulators have opened up Covid-19 booster shots to all and more adults on Friday. (File Photo / AP)
Published on Nov 19, 2021 07:33 PM IST
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Written by Joydeep Bose | Edited by Poulomi Ghosh, Hindustan Times, New Delhi

FDA promises quick review of Pfizer booster for all adults, CDC meets Friday

The decision from the FDA will likely come before a US Centers for Disease Control and Prevention (CDC) advisory panel meets on Friday to discuss expanding the eligibility for booster doses of Pfizer/BioNTech's vaccine, currently allowed for select groups of people.
US President Joe Biden's administration in August announced plans to roll out booster doses for all adults in September.(AP)
US President Joe Biden's administration in August announced plans to roll out booster doses for all adults in September.(AP)
Published on Nov 17, 2021 07:41 AM IST
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Reuters |
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