COVID-19 Update

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

Moderna announces supply agreement with the Argentina government for 20 million doses of Moderna’s COVID-19 vaccine.

The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

The first participants, both previously vaccinated and unvaccinated, receive AstraZeneca’s new COVID-19 variant vaccine AZD2816.

Vaccines define the path to putting pandemic restrictions and pain in the rear-view mirror.

Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

RECOVERY trial results have shown that Regeneron’s investigational antibody combination therapy reduces the mortality risk for seronegative hospitalized patients with severe COVID-19.

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

As COVID-19 continues to spread, industry leaders are banding together to stop the disease in its tracks.

The companies are expanding their collaboration to extend the drug substance manufacturing of Moderna’s COVID-19 vaccine with the addition of a new manufacturing line at Lonza’s Geleen, Netherlands, site.

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.