COVID-19 Update

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.

The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.

The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine).

BIA has welcomed the announcement from the UK government that genomics expertise and capacity will be offered globally to help identify new variants of the virus that cause COVID-19.

Sanofi will offer access to its infrastructure and expertise to help BioNTech produce over 125 million doses of its COVID-19 vaccine in Europe.

Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.

The companies have entered into an advance purchase agreement with COVAX to provide up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to lower-middle-income countries.

The company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 and MK-7110.

The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.

The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.

Estonia, Hungary, and Iceland have signed up to take part in a pilot of Guardtime's VaccineGuard—a newly developed platform aimed at supporting the global COVID-19 vaccination program.

Through the acquisition, Thermo Fisher will have access to Mesa’s PCR-based rapid point-of-care testing platform for detecting infectious diseases.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

The CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue.

This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies.

Packaging and transporting large quantities of COVID-19 vaccines pose challenges for the cold chain.

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

The company plans to expand its global production capacity across six existing manufacturing facilities in Europe and the United States, as well as a new manufacturing facility in the US.

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement.

Bayer will support the development and supply of CureVac’s COVID-19 vaccine candidate, CVnCoV.

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

The companies have entered into an agreement to support the formulation and fill/finish of Moderna’s COVID-19 vaccine supply outside of the United States.

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.