COVID News: Lilly, AstraZeneca, Merck & Co. & More

The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Lilly, AstraZeneca, Merck & Co., Novavax, Inovio, Bharat Biotech, Novatek, and BD.

Manufacturing and supply of COVID-19 vaccines and drugs

Lilly To Supply More Doses of COVID-19 Drugs to US Gov’t
Eli Lilly and Company has announced an additional purchase by the US government for bamlanivimab with etesevimab, co-administered for treating COVID-19. The antibody combination is authorized for emergency use for treating mild-to-moderate COVID-19 or for post-exposure prophylaxis of COVID-19 in certain individuals.

As part of the agreement, Lilly will supply 614,000 doses of bamlanivimab with etesevimab no later than January 31, 2022 for a total of $1.29 billion. A minimum of 400,000 doses will be supplied no later than December 31, 2021.

Source: Eli Lilly and Company

FDA OKs Two Lots of AstraZeneca’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has found two lots of AstraZeneca’s COVID-19 vaccine substance, manufactured at the Emergent BioSolutions’ facility in Baltimore, Maryland, to be acceptable for use for potential export.

The AstraZeneca vaccine is not authorized for use in the US, but the FDA says it understands that these AstraZeneca lots, or vaccine made from the lots, may be exported for use. The agency said it conducted a thorough review of facility records and quality-testing results performed by the manufacturer and reached its decision based on this review.

Source: US Food and Drug Administration

Updates on COVID-19 treatments and vaccines

UK Authorizes Merck & Co.’s Oral COVID-19 Drug
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the UK for Merck & Co.’s molnupiravir, an oral antiviral medicine for treating mild-to-moderate COVID-19 in adults.

In the UK, Lagevrio is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not yet been approved.

Last month (October 2021), Merck filed for emergency use authorization with the FDA for  molnupiravir and also announced that the European Medicines Agency initiated a rolling review of the company’s marketing authorization application. Merck says it is actively working to submit applications to other regulatory agencies globally.

Source: Merck & Co.

WHO Authorizes Bharat Biotech’s COVID-19 Vaccine
The World Health Organization (WHO) has issued an emergency use listing (EUL) for Covaxin, a COVID-19 vaccine by Bharat Biotech, a Hyderabad, India-based bio/pharmaceutical company.

WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for supplying vaccine to COVAX, a global initiative for equitable access to vaccines. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

Source: World Health Organization

Novavax Provides Update of COVID-19 Vaccine
Novavax has provided an update of its global filings and regulatory review of its COVID-19 vaccine.

The company reports that it has completed its rolling submission to Health Canada, Australia’s Therapeutic Goods Administration, and the New Zealand Medicines and Medical Devices Safety Authority for the respective authorization and provisional approvals for its COVID-19 vaccine.

The company has also completed the submission of all data and modules to the European Medicines Agency to support the final regulatory review of its dossier.

Separately, the National Agency of Drug and Food Control of the Republic of Indonesia has granted emergency use authorization for Novavax’s COVID-19 vaccine. It will be manufactured in India and marketed in Indonesia by the Serum Institute of India (SII), a Pune, India-based vaccine manufacturer, under the brand name Covovax.

Novavax and SII have already filed for authorization of Novavax’s COVID-19 vaccine in India and the Philippines, as well as for emergency use listing (EUL) with the World Health Organization. 

Source: Novavax (Australia), Novavax (Canada), Novavax (New Zealand), and Novavax (Indonesia)

Novatek Seeks Authorization for Oral COVID-19 Drug
The United States Food and Drug Administration (FDA) has granted a meeting with Novatek Pharmaceuticals, a clinical-stage bio/pharmaceutical company, to consider emergency use authorization (EUA) of its TQ Formula to treat non-hospitalized COVID-19 patients

Novatek reported topline results from a Phase II study evaluating the oral TQ Formula in COVID-19 patients in the outpatient setting. Based on the outcome of the study, the FDA has granted Novatek a Type B meeting to consider EUA of oral TQ Formula to treat non-hospitalized COVID-19 patients.

Source: Novatek

India OKs Phase III Trial of Inovio’s COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based bio/pharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received authorization from India’s Central Drugs Standard Control Organization’s (CDSCO) Drug Controller General of India (DCGI) to proceed with the Phase III segment of its planned Phase II/III clinical trial for INO-4800, its COVID-19 vaccine candidate.

Inovio is partnering with Advaccine Biopharmaceuticals Suzhou, a Suzhou, China-based bio/pharmaceutical company, to conduct the Phase III segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, Philippines, Mexico, and Colombia.

Source: Inovio

News on COVID-19 testing

BD, US Gov’t in Pact for COVID-19 Testing
Becton, Dickinson and Company (BD), a Franklin Lakes, New Jersey-based medical technology company, has formed a partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to support the development of a range of COVID-19 combination diagnostic tests for core laboratories, hospitals, and at point-of-care uses.

Separately, BD has developed an at-home rapid COVID-19 self-test. The BD Veritor At-Home COVID-19 Test uses the Scanwell Health mobile app to interpret and provide a digital display of testing results in 15 minutes. The test is available through December to US customers as part of its partnership with the US government.  

Source: BD (partnership) and BD (test)