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Continuous innovation for COVID-19 vaccines, diagnostics, and therapeutics

As new SARS-CoV-2 variants emerge, and regulatory agencies consider the inclusion of COVID-19 vaccines into annual immunization strategies, the innovative pharmaceutical industry continues its R&D efforts for vaccines that can target multiple strains of the virus and/or multiple viruses.

Pfizer and BioNTech receive Emergency Use Authorization of its Omicron BA.4/BA.5-adapted bivalent COVID-19 booster in children under 5 years. The vaccine also gets approval for ages 5-11 in Japan.

Third-year anniversary of COVID-19's declaration as a Public Health Emergency of International Concern (PHEIC). The US FDA Advisory Committee votes in support of favorable benefit-risk profile for Pfizer's COVID-19 antiviral, Paxlovid, for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.

Roche and the WHO partner to improve access to Roche's tocilizumab for COVID-19 in low- and middle-income countries.

The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) updates COVID-19 vaccination guidance, recommending COVID-19 vaccine booster doses only to high-risk groups.

Shionogi receives US FDA fast track designation for Ensitrelvir Fumaric Acid, an investigational oral antiviral for COVID-19.

Moderna announced that the next-generation, refrigerator-stable COVID-19 vaccine candidate, mRNA-1283, has entered Phase III clinical trial.

A delegation of 24 CEOs from the Biopharmaceutical CEOs Roundtable (BCR) meet with Japanese Prime Minister Fumio Kishida to share the lessons learned in bringing innovation in fighting COVID-19 and underscores the need for a science and innovation ecosystem built on the protection of IP rights and unhindered access to pathogens. The BCR also presents the Tokyo statement, outlining top priorities for addressing global health challenges.

Initial results from Novavax' COVID-19-Influenza Vaccine Trial show the feasibility of its combination vaccine.