COVID-19 Update

FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.

Moderna’s mRNA-1273.214 booster candidate exhibited an eight-fold boost in neutralizing geometric mean titers against Omicron.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

Pfizer will invest $120 million to produce COVID-19 oral treatment in the US.

EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.

Lions and tigers and monkeypox, oh my!

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

Investment has been made into a new science hub at the University of Edinburgh for the development of treatments for lung infections and future pandemics.

AstraZeneca has signed a license agreement with RQ Biotechnology for monoclonal antibodies to treat COVID-19.

Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.

The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

ReiThera and Exothera are collaborating to develop a large-scale, low-cost-per-dose manufacturing process to deliver novel vaccines to low and middle-income countries.

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Moderna has reached an agreement with the Ministry of Health, Labor, and Welfare of Japan (MHLW) to supply Japan with an additional 70 million doses of its COVID-19 Booster Vaccine.

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.

Johnson & Johnson have announced a landmark agreement to enable the manufacturing and availability of its COVID-19 vaccine in Africa by an African company.

Moderna has announced that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to establish its first mRNA manufacturing facility in Africa.