Pfizer, BioNTech to seek emergency COVID-19 vaccine nod on Friday

Modesto Morganelli
Novembre 21, 2020

Government officials anticipate having enough vaccine to inoculate about 20 million people with the two-dose regimen in the U.S.in December, between Pfizer's vaccine and a second shot likely to be considered for emergency authorization soon, from biotechnology company Moderna. But the increased rates are still extremely rare: an extra 1 to 2 cases for every million doses, according to the CDC.

It is unclear how long the FDA will take to review the application, though the agency is expected to move swiftly.

"We'll drill down on these data", said FDA adviser Dr. Paul Offit of the Children's Hospital of Philadelphia. "But I knew that it was an extremely risky suggestion, I knew it was going to be hard, and the stars needed to be aligned all the way to the end".

While Democrats were pursuing a highly divisive and entirely baseless impeachment endeavour, as far back as January 13, this President, the Trump administration, and the National Institute of Health were partnering with Moderna and working on this vaccine for the American people, Ms. McEnany said. The platform is fast and flexible for developing vaccines, since it only requires knowing the genetic sequence of the virus the vaccine will target, rather than growing and manipulating the virus in question.

Pfizer, a 171-year-old Fortune 500 powerhouse, has used its scientific and manufacturing muscle and a crucial partnership with BioNTech to develop a vaccine in record-breaking time. Instead, when the pandemic hit a year later, the teams shifted their attention to SARS-CoV-2, the novel coronavirus that causes COVID-19, with surprising success. "It really should show up within those two months after the second shot". I care for patients with COVID-19 and am conducting the local site for a phase 3 clinical trial of Regeneron's antibody cocktail as a tool to prevent household transmission of COVID-19. However, the U.S. government expects to approve the vaccine in the first half of December.

The trial also found that there were no "serious safety issues" with the vaccine and that the "severe" side effects of the shot were tired (3.8% of subjects) and headaches (2% of subjects).

"I'm afraid we still haven't made those decisions. Wearing a mask is something you need to do because science is telling you to do it".

Other vaccines are in late testing stages in China and Russian Federation.

USA health authorities cautioned Americans on Thursday against travelling for the Thanksgiving holiday next week, as the coronavirus spreads. "We have elected for developed countries, to give [the vaccine] at a very low price [around $19.50]".

The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the United Kingdom, the companies said. "If you think about the economic value of a vaccine-I'm not speaking about the human value because there is no way to measure human life-I think the millions of jobs that will not be lost, that hopefully will come back, and the billions in economic value that a successful vaccine will enable-I think it's not appropriate to discuss if we sell it at $19.50 per dose". "And if supported by the data, the FDA is likely to issue an EUA for this vaccine". But the federal government is using various methods to dramatically speed up the process for COVID-19 vaccines.

"If the regulator approves a vaccine we will be ready to start the vaccination next month with the bulk of roll-out in the new year".

To get to this point, Pfizer assessed its vaccine candidate through various stages of clinical trials, and ultimately found it was 95% effective. Take the simple steps that the doctors have talked about today because there is a light at the end of the tunnel.

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