Johnson & Johnson is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.

The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway.

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, Moderna's vaccine candidate against COVID-19, to support the Ministry's ongoing efforts to secure early access to a safe and effective COVID-19 vaccine for the people of Qatar.

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.

The Food and Drug Administration (FDA) authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.

CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced data from preclinical studies of its investigational SARS-CoV-2 vaccine candidate, CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and very good T cell activation.

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has completed enrollment of 30,000 participants for the Phase 3 COVE study of mRNA-1273, its vaccine candidate against COVID-19, being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the preclinical results for MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2, the virus that causes COVID-19 disease.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits.