COVID News: GSK, Novartis, Pfizer, Moderna & More

The latest on COVID-19 vaccines/drugs, manufacturing, and testing from GSK, Novartis, Pfizer, AstraZeneca, Moderna, Novavax, and BioNTech.

Manufacturing and supply of COVID-19 vaccines and drugs

US Gov’t To Buy More Doses of GSK’s COVID-19 Drug
The US government has agreed to purchase an additional 600,00 doses of sotrovimab for treating adults and adolescents with COVID-19, from GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based bio/pharmaceutical company.

The additional 600,000 doses will be delivered throughout the first quarter of 2022.This agreement is an amendment to earlier commitments announced with the US government in November 2021.

Including this amended commitments with the US government, GSK and Vir have received binding agreements for the sale of approximately 1.7 million doses of sotrovimab globally. In addition, this agreement also includes the option for the US government to purchase further additional doses in the second quarter of 2022.

GSK and Vir expect to manufacture approximately 2 million doses globally in the first half of 2022 and additional doses in the second half of 2022.

Sotrovimab was granted emergency use authorization by the US Food and Drug Administration in May 2021 for treating mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. It has also been granted a marketing authorization in the European Union, conditional marketing authorization in Great Britain, provisional marketing authorization in Australia, and conditional marketing authorization in Saudi Arabia. It has also been approved via Japan’s Special Approval for Emergency Pathway. Temporary authorizations have also been granted in 12 other countries.

This week (January 13, 2022), GSK and Vir Biotechnology announced the submission of an application to the FDA requesting an amendment to their EUA to include intramuscular (IM) administration. The current EUA for sotrovimab was for intravenous infusion.

Source: GlaxoSmithKline (Supply Pact), Vir Biotechnology (Supply Pact), and Vir Biotechnology (intramuscular administration request)

Updates on COVID-19 treatments and vaccines

Novartis, Molecular Partners AG Advance COVID Drug
Novartis and Molecular Partners AG, a Zurich-based clinical-stage bio/pharmaceutical company, report positive results from a Phase II study evaluating ensovibep, an antiviral therapeutic for COVID-19 and plans to further advance the drug.

Ensovibep is a designed ankyrin repeat protein (DARPin) therapeutic. DARPin therapeutics are mono- or multi-specific protein-based therapies designed to specifically engage their targets for various effects. Ensovibep was designed to include three individual DARPin domains, each highly neutralizing to SARS-CoV-2, the virus that causes COVID-19.

Novartis says it will exercise its option to in-license ensovibep from Molecular Partners, accelerate manufacturing scale-up, and plans to seek expedited regulatory authorizations globally, first via the US Food and Drug Administration’s emergency use authorization.

Upon completion of in-licensing, Molecular Partners will receive a milestone payment of CHF 150 million ($163 million) and be entitled to a 22% royalty on sales of ensovibep in commercial territories.

Source: Novartis and Molecular Partners AG

Pfizer Reports Results for COVID-19 Vaccine Combo
Pfizer reports positive results from a Phase III study evaluating Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for preventing invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes, when administered at the same time as the Pfizer’s/BioNTech’s COVID-19 vaccine. Pfizer says it will seek to present and publish detailed outcomes from this clinical trial at a future date (as reported on January 12, 2022).

Source: Pfizer

AstraZeneca Reports Data for COVID-19 Vaccine Booster
AstraZeneca reports positive results from a preliminary analysis of an ongoing trial that showed that its COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), when given as a third dose booster increased the immune response to Beta, Delta, Alpha and Gamma SARS-CoV-2 variants.  A separate analysis of samples from the trial showed increased antibody response to the Omicron variant. The results were observed among individuals previously vaccinated with either Vaxzevria or an mRNA vaccine.

A separate Phase IV trial reported that a third dose of Vaxzevria substantially increased antibody levels following a primary vaccine series with CoronaVac, a COVID-19 vaccine developed by Sinovac Biotech, a Beijing-based bio/pharmaceutical company.

AstraZeneca says it is submitting these additional data to health authorities globally. Further analyses from the trial are expected in the first half of 2022.

Source: AstraZeneca

FDA Shortens Time for Moderna’s COVID-19 Vaccine Booster
The US Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for Moderna’s COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.

Source: US Food and Drug Administration

South Korea OKs Novavax’s COVID Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has received approval from South Korea’s Ministry of Food and Drug Safety for its recombinant protein-based COVID-19 vaccine in individuals 18 years of age and older.

The vaccine, which will marketed under the name, Nuvaxovid, will be manufactured and marketed in South Korea by SK bioscience. SK bioscience has an advance purchase agreement with the South Korean government to supply 40 million doses of the vaccine. The companies also recently announced expanded collaboration and license agreements that are expected to increase manufacturing capacity and provide SK bioscience with additional non-exclusive territories.

Separately, Novavax and the Serum Institute of India (SII), a Pune, India-based vaccine manufacturer, have filed for emergency use authorization for the vaccine with South African Health Products Regulatory Agency. If authorized, the vaccine will be manufactured by and commercialized by SII in South Africa under the brand name Covovax.

Novavax’s COVID-19 vaccine has received authorizations in over 170 countries, including conditional marketing authorization in the European Union, emergency use listing from the World Health Organization, and emergency use authorization in India, Indonesia and the Philippines.

In addition, Ardena, a Gent, Belgium-based CDM, reports it will be expanding its capacity for purification and fractionation of GMP manufacturing at its site in Södertälje, Sweden, to satisfy long-term demand expected from Novavax for production of its COVID-19 vaccine. The expansion plan includes additional chromatography, tangential flow filtration, and lyophilization capabilities.

Source: Novavax (South Africa), Novavax (South Korea), and Ardena

News on COVID-19 testing

BioNTech Partners for COVID-19 Variant Testing System
BioNTech has partnered with InstaDeep Ltd, a London-based company of artificial intelligence (AI)-based products, for the development of a new computational method that analyses global sequencing data and predicts high-risk variants of SARS-CoV-2.

The Early Warning System is based on AI-calculated immune escape and fitness metrics. The EWS combines Spike protein structural modeling with AI to detect and monitor high-risk SARS-CoV-2 variants, identifying >90% of World Health Organization-designated variants on average two months prior to officially receiving the designation.

Source: BioNTech and InstaDeep