Healthcare Roundup – Vaccine cuts for several U.S. states due to FDA confusion, Pfizer/BioNTech COVID-19 vaccine cleared by EU

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Published on: December 21, 2020
Author: Amy Liu

Vaccine cuts for several U.S. states due to FDA confusion

Officials with Operation Warp Speed had to slash the number of COVID-19 vaccine doses for several states in America due to confusion over the FDA’s certificate of analysis requirement for vaccine rounds, CNBC reports.

The federal government’s error disrupted vaccination distribution plans in at least 14 states. Washington state, New Jersey, Virginia, Idaho, Michigan, Connecticut, California, Nevada, Minnesota, Wisconsin, Vermont, Massachusetts, Iowa and Oregon will experience a smaller number doses than expected.

The agency mistakenly assumed Pfizer’s (NYSE:PFE) vaccine was ready to ship when there was actually a two day lag period in which the FDA requires a certificate of analysis on each set of vaccines, said Dr. Moncef Slaoui, chief advisor of Operation Warp Speed.

“That lag period has resulted in differences in the plan and what was actually done,” Slaoui said Sunday in an interview to CNN.

A certificate of analysis is required for each round of vaccine at least 48 hours prior to distribution, but doesn’t require the certificate to be reviewed prior to shipment.

“The mistake I made is not understanding with exactness — again my responsibility — on all the steps that have to occur to make sure the vaccine is releasable,” Operation Warp Speed Chief Operating Officer Gen. Gustave Perna said at a press briefing.

U.S. shipped 2.9M doses of COVID-19 vaccines last week, with 2M doses allocated for this coming week’s shipment. Officials also plan to send out 5.9M doses of Moderna’s (NASDAQ:MRNA) vaccine this week.

Pfizer/BioNTech COVID-19 vaccine cleared by EU

The European Commission greenlighted the COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), hours after the European Medicines Agency issued a positive opinion to recommend it for conditional marketing authorization.

The decision by the EU’s executive arm will allow the two companies to roll out the vaccine across the 27-nation bloc. The deliveries are expected to start on Saturday, with inoculations beginning across the EU between December 27-29.

After receiving the positive opinion from EMA, the CEO of Pfizer’s German partner, BioNTech, said, “Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic.”

The decision by the Committee for Medicinal Products for Human Use of EMA was based on Phase 3 clinical data published in The New England Journal of Medicine in early December.

Who’s next in line to receive a coronavirus vaccine?

As trucks began delivering Moderna’s (NASDAQ:MRNA) shot to health departments, hospitals and other vaccination sites on Sunday, a Centers for Disease Control and Prevention panel voted on the next groups to receive inoculations.

Vaccination is already underway in the U.S. – via the Pfizer (NYSE:PFE) jab – for the so-called phase 1a group, which includes at least 24M healthcare workers and long-term care facility residents.

The 1b group, estimated to cover about 49M people, or nearly 15% of Americans, would encompass “frontline essential workers” (i.e. teachers, police and firefighters, grocery workers) and people 75 years of age.

Phase 1c will broaden eligibility to another 129M people, including persons between the ages of 65 and 74, people between the ages of 16 and 64 who have high-risk underlying conditions and remaining “essential workers.”

If accepted by the CDC director, the committee’s recommendations will set federal guidance, though state officials are charged with the final say on distribution.

FDA asks for additional information on OraSure’s COVID-19 antibody test application

OraSure Technologies (NASDAQ:OSUR) drops 6% after hours, as the FDA has requested additional information as part of its review of its Emergency Use Authorization (EUA) application for its laboratory-based oral fluid Covid-19 antibody test.

The OraSure SARS-CoV-2 Antibody ELISA is intended for qualitative detection of total antibodies to SARS-CoV-2 in human oral fluid specimens collected with the OraSure Oral Antibody Collection Device.

The company intends to resubmit two separate EUAs for the ELISA and the oral specimen collection device.

In addition, the FDA has requested that additional analytical studies be conducted on sample collection and stability

Curevac advances COVID-19 vaccine candidate to Phase 3 trial

Curevac (NASDAQ:CVAC) climbs +6.0% as the company announces the initiation of the Phase 3 study for its COVID-19 vaccine candidate, CVnCoV.

In the randomized, observer-blind, placebo-controlled trial involving more than 2,500 subjects 18 years of age and older, the first participant will be vaccinated on December 22, 2020, a statement from the company read.

Built on a non-interventional study on COVID-19 of 3,600 hospital employees at the University Hospital Mainz, the trial complements CureVac’s recently initiated global pivotal Phase 2b/3 trial, HERALD, for CVnCoV in more than 35,000 participants.

The company’s mRNA-based COVID-19 vaccine development program started in January, and its Phase 1 interim data have demonstrated an immune response comparable to recovered COVID-19 patients with the induction of strong antibody responses in addition to the first indication of T cell activation.

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