Wednesday, 02 December, 2020


Pfizer to file FDA coronavirus vaccine emergency approval Friday

Sleepy drug regulators mute witness to Covid vaccine one-upmanship leave investors patients at grave risk Regulators dreaded by pharma companies for their zero tolerance and harsh crackdowns have been mum on COVID vaccine developers bombastic claims
Conrad Doyle | 20 November, 2020, 16:12

The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.

According to the proposers, the United States medical authorities can use an accelerated procedure because of an emergency situation.

"I am confident that if everything goes well, and we have a very organized vaccine supply, that we could have a normal summer and winter 2021", Şahin said.

The Union health ministry had also said on Tuesday that the cold-chain requirements of Pfizer's coronavirus vaccine posed a big challenge to India's mass-vaccination campaign, but the government is examining all possibilities for its procurement. Experts said it was a significant achievement in the race to end the pandemic.

Pfizer and BioNTech are now in Phase 3 trials on the vaccine as is fellow pharmaceutical giant, Moderna.

US COVID-19 vaccine programme head Moncef Slaoui said there will not be any constraints on who gets what vaccine.

That could mean an emergency green light in time for the new year, Şahin said.

"The federal government has a contract with both of these companies, both Pfizer and Moderna, to receive vaccine here in Canada, and what we are planning for is early in the next year, in the new year, to be able to start distributing that vaccine".

An FDA advisory committee tentatively plans to meet on December 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment.

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The new data showed the vaccine was generally well tolerated, with most side-effects short-lived and either mild or moderate. This equates to a 95 percent efficacy rate.

The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations nearly daily.

In older adults, who are most at risk from the virus and have weaker immune systems, the vaccine worked as well as it did in younger people. As reported by USA Today, a report released Monday by the American Academy of Pediatrics and the Children's Hospital Association found the number of US infants, children and teens diagnosed with COVID-19 has surpassed 1 million.

Similarly, on NSE, shares of Pfizer Ltd rose by 3.85% to ₹ 5,096.20.

"The companies will be ready to distribute the vaccine candidate within hours after authorization", their statement said.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations, it will be months before large-scale rollouts begin in either country. In regular freezers they can be stored for only five days.

According to Bloomberg News, both vaccines rely on a technology called messenger RNA, which, until now, has never been used to build an approved vaccine.

Moderna reported more Grade 3 side effects. Final results and safety data are expected in the coming days or weeks. Johnson & Johnson said it is on track to deliver data this year.

Virus specialists, including Anthony Fauci, the leading infectious disease doctor in the USA, predicted in early 2020 that it would take between one year and 18 months to develop a vaccine to cope with contagion. The Pfizer and BionTech vaccine went into tests shortly thereafter.

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