FDA News
This development comes after a purported video of Shiv Sena MLA Sanjay Gaikwad surfaced, showing him allegedly assaulting an employee at the canteen over what he claimed was "stale food."
Blinkit and Zepto were found in Violation of Schedule 4 of the Food Safety and Standards Act, 2006.
Maharashtra FDA Commissioner Abhimanyu Kale stated that they received customer feedback regarding the use of cheese analogues instead of real cheese.
The Mumbai-based drug major had produced the lot at its Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by its US-based unit.
The Johnson and Johnson vaccine was authorised for emergency use in February last year.
As of mid-March, federal scientists had identified 60 cases of the side effect, including nine that were fatal.
FDA said the shot should only be given to adults who cannot receive a different vaccine.
The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.
Moderna is now seeking Food and Drug Administration (FDA) approval for its fourth shot of the Covid-19 vaccine to be administered as a booster dose in eligible adults.
An expert panel of the Central Drugs Standard Control Organisation had recently approved the antiviral Molnupiravir for restricted use in emergency situations, However, ICMR has raised concern over its side effects.
The AstraZeneca antibody-drug cleared by the US Food and Drug Administration on Wednesday is different. It's the first authorised for long-term prevention against COVID-19 infection, rather than short-term treatment.
Pfizer's shot is the only approved COVID jab for children under 18 in US
Bharat Biotech's Covaxin got WHO nod for emergence use listing recently
Vaccination is the most important step, say experts, in combating the pandemic
A Food and Drug Administration advisory panel voted unanimously, with one abstention, that the vaccine's benefits in preventing COVID-19 in that age group outweigh any potential risks including a heart-related side effect that's been very rare in teens and young adults despite their use of a much higher shot dose.
FDA approved the use of third doses of Moderna and Johnson & Johnson vaccines.
FDA also approved "mix and match" booster doses.
The booster dose is to be administered at least six months after completion of the second dose, and the authorization would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said.
Pfizer COVID vaccine may be authorised for 5-year-olds by October
Pfizer, Moderna and Johnson and Johnson are conducting clinical trials to evaluate the safety and efficacy of the vaccines in children under 12
Results of the Pfizer vaccine for children are expected in September.
The drug Actemra (tocilizumab), which is used for arthritis can be given to hospitalised COVID-19 patients in the USA
However, Actemra is not authorised for use in outpatients with COVID-19
FDA has told the the US partner of the Indian vaccine maker to go for Biologics Licence Application route
The development may delay the Covaxin launch in the US
The company will pursue expedited authorisation for the vaccine in Canada
Pfizer to seek FDA emergency authorisation to administer its coronavirus vaccine among children between the ages of 2 and 11 in September
Pfizer is already expected to get FDA approval for emergency use of its vaccine in children 12 to 15 years old
FDA approves use of Pfizer-BioNTech coronavirus vaccine for adolescents aged 12 to 15 years
Vaccinating adolescents may also be key to boost immunity levels in the general population
COVID pills could be ready by the end of 2021
The pills are protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells
Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C
US FDA has authorized Pfizer's COVID-19 vaccine for emergency use
President Donald Trump has promised the first immunizations would take place "in less than 24 hours."
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