Fauci says Pfizer, Moderna Covid vaccine data is 'solid'

Andrew Cummings
November 20, 2020

This type of Food and Drug Administration authorization is temporary or conditional and is granted in response to an emergency situation such as a pandemic.

"If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively", he said.

USA health officials on Wednesday said that freezers required to store Covid-19 vaccines are in place and Operation Warp Speed has identified hospitals, pharmacy chains and universities that have cold storage storage capacity. Experts said it was a significant achievement in the race to end the pandemic.

"Cambridge, Massachusetts-based Moderna received $955 million from the U.S. Operation Warp Speed program to develop its vaccine", says Bloomberg.

And, according to The New York Times, there are 10 other vaccines using messenger RNA now in late-stage trials across the globe.

Dr. Peter Chin-Hong, an infectious disease specialist at UC San Francisco, said the symptoms typically appear in the first few hours after vaccination and resolve within 24 to 36 hours.

The official disclosed the survey plan at a meeting of the health committee of the House of Representatives on Wednesday. The FDA did not respond to requests for comment.

The vaccine trial will continue to follow all participants for two more years in order to collect detailed safety data.

Those data arrived Wednesday, showing an efficacy rate of 95%.

The twin breakthroughs have lifted hopes for an end to a pandemic that has infected more than 56 million people and caused more than 1.3 million deaths worldwide since the virus first emerged in China late a year ago.

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

"This is the evidence we needed to ensure that the most vulnerable people are protected", said Andrew Hill, senior visiting research fellow at the University of Liverpool's department of pharmacology.

The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer's vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers. Moderna shares fell 3.6 percent.

Fauci said the coronavirus vaccines quickly created by Moderna and Pfizer are the result of "extraordinary" advances in medicine and the developers did not compromise safety or scientific integrity.

Pfizer and BioNTech estimate by the end of 2020 up to 50 million doses will have been manufactured globally. The fragility of mRNA makes it unlikely to linger in the body but any vaccine could theoretically cause disruptions in the immune system, experts said. In regular freezers they can be stored for only five days. The worst adverse effects reported so far have been mild headaches (in 2.2 percent of the cohort) and fatigue (in 3.8 percent of the cohort).

Data showed 162 cases occurred in the placebo group versus eight in the BNT162b2 group. Johnson & Johnson said it is on track to deliver data this year. That will set off a process in which FDA scientists will begin to assess the accuracy of company data, which is likely to take two to three weeks. The Pfizer and BionTech vaccine went into tests shortly thereafter.

Moderna too is likely to apply soon for the emergency authorization of its own vaccine.

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