Pfizer/BioNTech to seek emergency vaccine approval in US Friday

Pfizer/BioNTech to seek emergency vaccine approval in US Friday

That's good news for a country such as the United Kingdom, but not such good news for developing countries which haven't got the money to place bids.

As I am sure you have heard by now, two major pharmaceutical companies - Pfizer and Moderna - have announced successful COVID-19 vaccine trials. According to numerous reports, the Pfizer vaccine appears to be 90% effective in preventing infections. What does this mean?

Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94 percent.

The trial, which is testing people at 150 sites in the US, Germany, Turkey, South Africa, Brazil and Argentina, will collect data on the safety and efficacy of the vaccine for another two years.

Pfizer Inc said it will apply to US health regulators on Friday for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus. It is also pointed out that the true effectiveness of a vaccine can only be determined once it moves out of trials and millions of people get it. "It's not approved yet", Dr. Marion Gruber, chief of FDA's vaccine office, told the National Academy of Medicine this week. This part, chosen and capable of telling the cells how to react, was then coated in lipid before being injected into them.

" It is absolutely unprecedented to have two vaccines with highly promising data from Phase 3 trials less than a year after the global emergence of a new pathogen", Azar said Monday in a call with journalists. "The fact that Pfizer and (their partner) BioNTech have gotten encouraging results is making experts optimistic about the entire field", the Times' Carl Zimmer and Katie Thomas point out. "We need to actually double down on the public health measures as we're waiting for that help to come".

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The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN this week.

Out of 170 cases of covid-19 so far, 162 were in the placebo group - a strong signal the vaccine protected people.

"With respect to the flu vaccine, we did prioritize people in long term care homes, people in hospitals, and people in congregate living settings, because they are the more vulnerable and they need to be protected", Elliott said. A Forbes report speculates that "demand for treatments is likely to remain strong through the winter and possibly until the vaccine is administered at scale - a process that could take at least a year or two".

None of the funds would have had a place to go without the work of scientists who developed vaccine manufacturing techniques for decades. "It's just so much easier to make them at scale". There are also five DNA vaccines and several adenovirus vaccines in human trials now. Ten COVID-19 cases in the trial were cited as "severe", but only one of those severe cases was detected in the active vaccine group. However, the next big challenge now lies in distribution of the vaccine doses once it gets approval from the FDA. Availability of the vaccine in India will be subject to approval by domestic regulators, and the Indian government agreeing to purchase them.

With concerns growing that poor nations could be left behind in the scramble, Sahin said BioNTech was talking to organizations like the World Health Organization and the Bill and Melinda Gates Foundation on distributing the vaccine "worldwide", and finding ways to reduce its cost.

"My message to the American people is to hang in there with us". Children now account for 11.5% of all cases in states reporting cases by age.

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