German vaccine maker gives hope as United States virus deaths top 250,000

Ruben Fields
November 21, 2020

"When you see vaccines start to equal or exceed demand is when you'll see it out of the pharmacies", said Ms. Whicker.

"In that way, the vaccine could be used and distributed in the United States", he added, saying that authorization could come around 1-2 weeks after the VRBPAC meeting.

It is widely expected that the FDA will then issue an emergency use authorization for the two-dose vaccine, which has been shown to be highly effective in preventing Covid infections.

Pfizer and BioNTech are off to the races.

USA biotech giant Pfizer and German partner BioNTech sought approval Friday to roll out their coronavirus vaccine early, a first step toward relief as surging infections prompt a return to shutdowns that traumatized nations and the global economy earlier this year. If obtained, as many as 20 million Americans could be immunized by the end of the year, per U.S. officials.

Both Pfizer and BioNTech released interim results of their COVID-19 vaccine trials, which demonstrated a 90 percent effectiveness rate.

On Monday, a vaccine candidate from biotechnology firm Moderna clocked in with almost 95 percent efficacy at an early analysis.

If there's an emergency green light, "that vaccine is still deemed investigational".

Governments are now pinning their hopes on a vaccine that can save them from business and school closures and the stay-at-home orders that put people's mental health under severe strain. "We don't know what that vote's going to be", said former FDA vaccine chief Norman Baylor.

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In an in-depth conversation about the journey the company has taken in developing its vaccine, Bourla admitted that, throughout the process, he wasn't always sure that having a safe and effective vaccine ready for FDA review in less than a year was possible.

After the FDA staff review, an independent panel of doctors from major USA academic centers will meet to advise the FDA on the vaccines' efficacy-likely in early December.

Initial doses are likely to go to people at high risk for catching COVID-19, such as health care workers, and those most likely to suffer severe cases of the disease, including the elderly and people with underlying health conditions.

"The idea is just to collect all the info from that trial and we are waiting now for feedback from the FDA to have a VRBPAC (Vaccines and Related Biological Products Advisory Committee) meeting and after that a potential authorization for our emergency use authorization", he said.

An emergency authorization expedites the usual approval process through the FDA.

Given the urgency, the FDA is expected to move quickly. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people? Between Pfizer and Moderna, Azar said, the USA should have access to about 40 million doses by the end of December, enough for 20 million people to get the two-dose regimen.

However, vaccinations will be unable to be administered without the Centers for Disease Control and Prevention (CDC) advisory committee review, who will also decide which groups will receive the vaccine first, and will determine whether everyone should get the vaccine.

Moderna's vaccine also must be kept in a freezer for long-term storage, but at minus 4 degrees Fahrenheit. This will require pharmaceutical companies to continue their studies, even after they apply for emergency authorization. The submission also includes safety data on approximately 100 children between the ages of 12 and 15 years.

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