Healthcare Roundup – U.S. FDA gives Moderna’s COVID vaccine emergency use authorization; Pfizer/ BioNTech COVID-19 vaccine rollout reaches long-term care facilities

Published on: December 18, 2020
Author: Amy Liu

U.S. FDA gives Moderna’s COVID vaccine emergency use authorization

Moderna (NASDAQ:MRNA) gets emergency use authorization of mRNA-1273, its vaccine against COVID-19, from the U.S. Food and Drug Administration, making it the second vaccine to gain EUA in an effort to stem the pandemic.

Delivery of the vaccine to the U.S. government will begin immediately; ~20M doses will be delivered by the end of December.

The U.S. government has ordered a total of 200M doses of the Moderna vaccine to date and has an option to buy up to an additional 300M doses.

Moderna will continue to gather additional data and plans to file a Biologics License Application with the FDA requesting full licensure in 2021.

Earlier today, Moderna announced that the European Commission exercised its option to buy an additional 80M doses of the vaccine, bringing its total order commitment to 160M doses.

Pfizer/ BioNTech COVID-19 vaccine rollout reaches long-term care facilities

Walgreens Boots Alliance (NASDAQ:WBA) announced today the company has started the administration of the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) to residents and staff at long-term care facilities.

As part of the CDC’s Pharmacy Partnership for Long-term Care Program, the pharmacists will begin the vaccinations at nursing homes and assisted living facilities in Ohio and Connecticut, the company said.

With vaccinations in approximately 800 long-term care facilities across 12 states from next week, the company intends to expand the program to nearly 3M residents and staff at 35,000 long-term care facilities as the states finalize their distribution plans and receive the vaccine shipments.

Last week, the mRNA-based vaccine from Pfizer and BioNTech became the first to receive the emergency use authorization from the FDA.

Vir Biotech’s COVID-19 agents could be ‘NPV negative’: Baird

Vir Biotechnology (NASDAQ:VIR) has earned a critical review from Baird over its recently started Phase 3 clinical trial for VIR-7831, a fully human anti-SARS-CoV-2 investigational monoclonal antibody.

The analyst, Madhu S. Kumar, and the team reiterates their ‘Underperform’ rating on the stock with a price target of $24.

The company has collaborated with GlaxoSmithKline plc (NYSE:GSK) in the randomized, placebo-controlled, multicenter trial, designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19.

Citing issues faced by other developers of monoclonal antibody therapies against COVID-19, the analyst notes, ‘we genuinely don’t understand starting a hospitalized COVID-19 mAb trial now.’

The Phase 3 trial for first COVID-19 antibody therapy to win EUA, bamlanivimab, from Eli Lilly (NYSE:LLY) is on hold over safety concerns, while in its trial for REGN-COV2, a combination of two monoclonal antibodies, Regeneron (NASDAQ:REGN) has put on hold the enrollment of patients requiring high-flow oxygen or mechanical ventilation.

Citing the observations and given the efficacy of mRNA vaccines reducing the ‘prophylaxis opportunity’, analysts conclude ‘these agents could in time easily prove NPV-negative.’

In ‘key collaborations with large players’ for long-tailed asset returns, ‘the partners do the heavy lifting in commercialization,’ says Seeking Alpha contributor, Zach Bristow, with a Neutral view on the stock.

Myovant Sciences scores FDA approval for Orgovyx in prostate cancer

The FDA has announced it has granted the approval to Myovant Sciences (NYSE:MYOV) for Orgovyx (relugolix) in the treatment of adult patients with advanced prostate cancer.

Richard Pazdur, M.D., the Director of the FDA’s Oncology Center of Excellence, said, “Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider.”

Orgovyx, an oral therapy, reduce the secretion of the hormone, testosterone, by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone.

The currently approved therapies of his type for prostate cancer are injected or placed as small implants under the skin.

The approval was based on the results of a randomized, open-label trial in men with advanced prostate cancer where 622 patients who received Orgovyx achieved and maintained 96.7% of castration rate (low enough levels of testosterone) by day 29.

In June, the company announced that the FDA accepted the marketing application for relugolix for prostate cancer, with an action date set for December 20.

Moderna’s COVID-19 vaccine gets more orders from Europe

Moderna (NASDAQ:MRNA) announced today that the European Commission has exercised its option to purchase an additional 80M of its COVID-19 vaccine candidate, expanding the company’s total order commitment to 160M doses.

Following the regulatory approval by the EMA, Moderna expects to begin deliveries to Europe from early 2021. With the latest announcement, the total global orders for the mRNA-1273 vaccine expands to more than 470M doses.

The company’s dedicated European supply chain will be commissioned for deliveries subject to positive opinion from the European Medicines Agency’s scientific committee for human medicines and the European Commission’s Decision regarding the Conditional Marketing Authorization for the vaccine.

The EU has moved forward the timeline for COVID-19 vaccine authorization with EMA preparing to finalize the approval for the Pfizer (NYSE:PFE) -BioNTech (NASDAQ:BNTX) COVID-19 vaccine by December 23 instead of  December 29. The Amsterdam-based agency, has also moved forward the meeting to discuss the authorization for Moderna vaccine to January 06 from January 12.

Yesterday, the FDA’s expert panel endorsed the experimental vaccine against COVID-19, paving the way for company to become the second in line to win emergency authorization in the U.S.

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