COVID News: J&J, Roche, GSK & More

The latest on COVID-19 vaccines/drugs and manufacturing from J&J, Roche, GSK, Novavax, WHO, Bharat Biotech, and FDA.

Manufacturing and supply of COVID-19 vaccines and drugs

WHO Suspends Bharat Biotech’s COVID Vaccine for Mfg Issues
The World Health Agency has suspended the supply of Bharat Biotech’s COVID-19 vaccine Covaxin, to UN procurement agencies and recommended that countries using the vaccine take action as appropriate. Bharat Biotech is a Hyderabad, India-based bio/pharmaceutical company

The suspension is in response to the outcome of a WHO inspection from March 14–22, 2022, and the need to conduct process and facility upgrade to address recently identified GMP deficiencies.

WHO reports that Bharat Biotech says it is committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and WHO. In the interim and as a precautionary measure, the company has indicated that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future.

Source: World Health Organization

Updates on COVID-19 treatments and vaccines

WHO Recommends J&J’s COVID-19 Vaccine for Booster Use
The World Health Organization (WHO) has issued an updated emergency use listing (EUL) for Johnson & Johnson’s (J&J) COVID-19 vaccine, recommending the vaccine for use in boosted regimens in persons aged 18 years and older.

The updated EUL recommends J&J’s COVID-19 vaccine be used both as a homologous booster (same vaccine) after a single-dose primary vaccination and as a heterologous booster (“mix-and-match” vaccines) following a primary mRNA vaccine regimen.

J&J’s COVID-19 vaccine booster has also received emergency use authorization from the US Food and Drug Administration and a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Source: Johnson & Johnson

FDA Grants Priority Review for Roche’s Arthritis Drug for COVID-19
The US Food and Drug Administration (FDA) has accepted Roche’s supplemental biologics license application (sBLA) and granted priority review for Actemra/RoActemra (tocilizumab), a drug approved for treating rheumatoid arthritis and authorized for emergency use for treating COVID-19. The sBLA is for treating COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. A decision on FDA approval is expected in the second half of this year (2022).

In June 2021, Actemra/RoActemra received emergency use authorization from the FDA for treating COVID-19, and the drug is currently approved for use in 16 countries globally for defined patients hospitalized with severe or critical COVID-19. In February 2022, the World Health Organization (WHO) prequalified Actemra/RoActemra for patients with severe or critical COVID-19 to support access to care in low- and middle-income countries.

Source: Roche

Novavax Requests to Expand EU OK of COVID-19 Vaccine in Adolescents
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has submitted a request to the European Commission to expand the conditional marketing authorization of its COVID-19 vaccine, Nuvaxovid, in the European Union to adolescents aged 12 through 17 years.

The Drugs Controller General of India recently approved the vaccine for restricted use in emergency situations for adolescents aged 12 through 17 years in India. SK bioscience, Novavax’s licensee in South Korea, recently submitted an application for rolling review for adolescent authorization of the vaccine to the Korean Ministry of Food and Drug Safety. Novavax expects to initiate rolling submissions of regulatory filings in this age group to additional regulatory authorities worldwide and to initiate additional studies globally evaluating younger age groups during the second quarter of 2022.

Source: Novavax

FDA Removes OK for GSK’s COVID-19 Drug Due to Variants
The US Food and Drug Administration (FDA) has announced that sotrovimab, a drug for treating adults and adolescents with COVID-19 from GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based bio/pharmaceutical company, is no longer authorized to treat COVID-19 in any US region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.

Data from the Centers for Disease Control and Prevention estimates that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% in all US regions. Data included in the healthcare provider fact sheet shows the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Due to these data, sotrovimab is not authorized in any US state or territory at this time (as reported on April 5, 2022).

The FDA says it will continue to monitor BA.2 in all US regions and will provide follow-up communication when appropriate.

Source: US Food and Drug Administration

FDA Revises EUA Guidance To Reflect COVID-19 Variants
The US Food and Drug Administration (FDA) has revised its guidanceEmergency Use Authorization for Vaccines to Prevent COVID-19, to reflect updated recommendations for the clinical data to support effectiveness of a COVID-19 vaccine that has been modified to target a particular SARS-CoV-2 variant of concern.

The revised guidance also provides the most up-to-date recommendations based on lessons learned during the COVID-19 public health emergency and submissions by sponsors. The FDA also revised the guidance to delete the expectation that sponsors should continue to collect placebo-controlled data after issuance of an EUA. The FDA says it may not be feasible to continue to collect placebo-controlled data when an effective vaccine is authorized and available for study participants.  

Source: US Food and Drug Administration