Covid-19 Update

The outcomes of a workshop organized by WHO and ICMRA regarding COVID-19 vaccine strain updates are presented in a report published by regulators.

Industry investments indicate increasing trust in the newest modalities, including mRNA approaches.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.

Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.

Anthony Fauci announced that he plans to step down as Director of the National Institute of Allergy and Infectious Diseases in December 2022.

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.

FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.

Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.

The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.

The agency will review laboratory study and CMC data on the bivalent vaccine that targets two strains of the SARS-CoV-2 virus.

FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.

Moderna’s mRNA-1273.214 booster candidate exhibited an eight-fold boost in neutralizing geometric mean titers against Omicron.