POST 74. November 20, 2020. CORONAVIRUS. Pfizer…submitted to the FDA for emergency use authorization for their coronavirus vaccine candidate. —FDA issued an EUA for the drug baricitinib, in combination with remdesivir, as WHO says remdesivir doesn’t do much of anything.

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“This is the first coronavirus vaccine to seek regulatory clearance in the United States…

The vaccine, known as BNT162b2, could potentially be available for use in high-risk populations in the United States by the middle to end of December, Pfizer and BioNTech said in a statement earlier Friday. The vaccine requires two doses a few weeks apart, and protection is achieved 28 days after the first shot.

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.

The final analysis from the trial found the coronavirus vaccine was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer and BioNTech said this week. The submission also includes safety data on about 100 children ages 12 to 15.

About 42% of global participants and 30% of US participants in the Phase 3 study have racially and ethnically diverse backgrounds, the companies said in a news release, and 41% of global and 45% of US participants are ages 56 to 85…

Emergency use authorization, or EUA, from the FDA is not the same as full approval. An EUA allows products to be used under particular circumstances before all the evidence is available for approval. For an EUA, the agency says it will determine whether a product’s “known and potential benefits outweigh its known and potential risks.”

Pfizer’s application for EUA is “encouraging,” but the Infectious Diseases Society of America stressed in a statement on Friday that a transparent review of Pfizer’s data is still needed.

“While encouraging data from the Pfizer/BioNTech COVID-19 vaccine trial indicate the welcome possibility of a critical new tool against the pandemic, a comprehensive, transparent review of data, including evidence that the vaccine has been studied in diverse populations, remains essential to ensure its safety, effectiveness and acceptance,” Dr. Barbara Alexander, president of IDSA, said in the statement.

“If emergency use authorization is granted, clinical trials and data collection must continue. Measures that include wearing masks, frequent handwashing, maintaining physical distance and restricting the size of gatherings will remain crucial,” the statement said in part. “Finally, new federal funding must be provided for widespread, fair and equitable vaccine distribution in addition to campaigns to build vaccine confidence.”” (A)

“The process of issuing an EUA involves five steps:

Determination of an emergency;

Declaration of an emergency;

Review of the request for EUA by the FDA;

Issuance of the EUA or denial of the request; and

Termination of the EUA.

The determination of an emergency can be made by HHS, Department of Homeland Security, or Department of Defense. The emergency can be a military, domestic, or public health emergency that affects, or has a significant potential to affect, national security. Agents involved include chemical, biological, radiological, or nuclear agents. Both the determination and the declaration of the emergency must state the nature of the threat involved.

Once a determination of an emergency has been made and an emergency has been declared, the FDA reviews the EUA request and, if feasible and appropriate given the circumstances of the emergency, consults with the National Institutes of Health and the CDC. If the request is found to meet statutory criteria, the FDA Commissioner issues an EUA. The termination of an EUA is linked to the declaration—once the declaration expires, so does the EUA. A single declaration can support multiple EUAs as necessary.” (B)

“Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.

“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, M.D. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.” (C)

“After a clinical trial in April showed that remdesivir sped up the recovery of people with severe cases of the disease, the U.S. snapped up millions of vials of the drug from its manufacturer Gilead Sciences. Over the summer, European regulators rapidly signed off on the product, leading to nations around the world signing purchase agreements for the drug. And last month, the U.S. Food and Drug administration also signed off.

Now the WHO says remdesivir doesn’t do much of anything to improve the health of people hospitalized with COVID-19.

The recommendations are based on the WHO’s Solidarity Trial, which is examining several coronavirus treatments including remdesivir on more than 11,000 patients in 30 countries.

The WHO panel says the data from the trial shows that remdesivir has “no meaningful effect on mortality or on other important outcomes for patients.”

Remdesivir gained even more prominence in October when it was given to President Donald Trump as part of his treatment after he contracted the virus.” (D)

(A)Pfizer and BioNTech apply for FDA emergency use authorization for coronavirus vaccine, by Jamie Gumbrecht,

(B) Emergency Use Authorization,

(C) Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19,

(D) WHO Trial Finds Remdesivir Has ‘No Meaningful Effect’ In COVID-19 Patients, by JASON BEAUBIEN,


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