Healthcare Roundup – EU may approve BioNtech, Moderna vaccines in December; Pfizer set to file FDA application for vaccine today

Published on: November 20, 2020
Author: Amy Liu

EU may approve BioNtech, Moderna vaccines in December, could pay $10B for doses

According to the head of European Commission (EC), Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) could receive conditional European Union (EU) marketing authorization for their COVID-19 vaccines in the second half of next month – Bloomberg.

The EMA is in daily contact with the FDA about the evaluation of the vaccines in order to “synchronize” assessment, said EC President Ursula von der Leyen.

The speedy regulatory assessment comes as many European countries battle new waves with the onset of colder weather, forcing governments to impose new lockdowns. European leaders are increasingly counting on vaccines to provide relief.

The EU could pay more than $10B to buy hundreds of millions of vaccine doses jointly developed by PFE and BNTX as well as that of CureVac, Reuters said Friday, EU official name not disclosed.

Bloc has agreed to pay €15.50 ($18.34) per dose for Pfizer-BioNTech shot, less than what the U.S. is paying.

The EU has confirmed a purchase of up to 300M doses of Pfizer and BioNTech’s vaccine and has also inked supply agreements with AstraZeneca (NASDAQ:AZN), Sanofi (NASDAQ:SNY)/GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), and CureVac (NASDAQ:CVAC). In total, it’s pre-ordered some 1.2B doses.

Von der Leyen said the Brussels-based commission will “hopefully soon” reach a vaccine-supply agreement with Moderna and is also in talks with Novavax (NASDAQ:NVAX).

Pfizer set to file FDA application for vaccine today

There’s a lot to digest on the COVID front.

Pfizer (NYSE:PFE) intends to file an application to the FDA for emergency use of its coronavirus vaccine today, according to Health and Human Services Secretary Alex Azar, with Moderna (NASDAQ:MRNA) soon to follow.

Earlier this week, Azar said there will be roughly 40M doses of vaccine available by the end of this year between the two companies, enough to inoculate about 20M people.

Both vaccines have shown about 95% efficacy rates in late stage trials and are seen by investors and policymakers as a solution to get the economy going again.

AstraZeneca’s additional Imfinzi fixed-dose OK’d in U.S.

AstraZeneca’s (NASDAQ:AZN) Imfinzi (durvalumab) has been approved in the U.S. for an additional dosing option, a 1,500mg fixed dose every four weeks, for Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated bladder cancer.

This new option is consistent with the approved Imfinzi dosing in small cell lung cancer and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.

This new four-week dosing option gives doctors the choice to cut the number of visits in half and offers a more convenient regimen for patients.

Amarin rises 23% on ‘positive’ late-stage data in VASCEPA trial in China

Amarin (NASDAQ:AMRN) jumps 23% after-hours after sharing positive top-line results from Protocol Number EDPC003R01, a Phase 3 clinical trial of Vascepa (icosapent ethyl) conducted in China by partner, Edding.

The study, which investigated Vascepa as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint.

The median baseline TG levels in the study were 812 mg/dL and 837 mg/dL for the patients assigned to placebo (n=123) and 4 grams per day of Vascepa (n=122), respectively.

The Vascepa patient group showed a statistically significant median TG decrease of 19.9% (p<0.001) compared to placebo at the end of the 12 weeks.

The study’s primary endpoint, the percent change in TG levels from baseline to week 12, was met for the 4 gram per day Vascepa dose group.

Vascepa was well-tolerated with a safety profile similar to placebo. No treatment-related serious adverse events were seen.

The findings are being prepared to support Edding’s dossier for seeking regulatory approval for Vascepa in China.

Israel nears deal for AstraZeneca’s COVID-19 vaccine – Reuters

Israel has reached an understanding with AstraZeneca (AZN +1.8%) to receive ~10M doses of its experimental COVID-19 vaccine; details of the agreement are being finalized. An initial supply is expected to arrive during 1H of 2021, subject to regulatory approval.

According to recently published data, AstraZeneca’s vaccine candidate produced a strong immune response in older adults.

The  country has signed supply agreements with Pfizer (PFE +1.8%) and Moderna (MRNA +5.2%), and is in talks with Russia for its Sputnik V vaccine.

Israel is also developing its own vaccine that, if successful, could be ready for sale by the end of the summer.

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