COVID News: AstraZeneca, Pfizer, WHO & More
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The latest on COVID-19 vaccines/drugs from AstraZeneca, Pfizer, BioNTech, Novavax, and the World Health Organization. Highlights below.

Updates on COVID-19 treatments and vaccines

* WHO Authorizes 11th COVID-19 Vaccine
* EU OKs Booster Dose of AstraZeneca’s COVID-19 Vaccine
* Pfizer, BioNTech Update on Third Dose of COVID Vaccine in Children
* Novavax Files for EU OK of COVID-19 Vaccine Booster in Adults


Updates on COVID-19 treatments and vaccines

WHO Authorizes 11th COVID-19 Vaccine
The World Health Organization (WHO) has issued an emergency use listing (EUL) for Convidecia, a COVID-19 vaccine manufactured by CanSino Biologics, a Tianjin, China-based bio/pharmaceutical company, making this the 11th COVID-19 vaccine validated by WHO.

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.

Convidecia is based on a modified human adenovirus that expresses the spike S protein of SARS-CoV-2. It is administered as a single dose.

Source: World Health Organization


EU OKs Booster Dose of AstraZeneca’s COVID-19 Vaccine
AstraZeneca’s COVID-19 vaccine, Vaxzevria, has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.

The authorization is based on a review by the EMA’s Committee for Medicinal Products for Human Use of evidence demonstrating an increased immune response after a third dose booster with Vaxzevria following a primary vaccine schedule of either Vaxzevria or an mRNA COVID-19 vaccine.

Vaxzevria is already authorized as a homologous booster (patients previously given a primary vaccine schedule of Vaxevria) in the UK, and several countries in Asia and Latin America. It has also been authorized as a heterologous booster (patients previously given a primary vaccine schedule of either a viral vector vaccine other than Vaxzevria or an inactivated vaccine or an mRNA COVID-19 vaccine) in a number of non-EU countries.

Source: AstraZeneca


Pfizer, BioNTech Update on Third Dose of COVID Vaccine in Children
Pfizer and BioNTech have reported positive efficacy data from a Phase II/III trial evaluating a third 3-µg dose of their COVID-19 vaccine in children six months to under five years of age. Following a third dose in this age group, the vaccine was found to elicit a strong immune response.

Studies in adults, adolescents, and children over five years of age continue to indicate that three doses of the Pfizer’s/BioNTech’s COVID-19 vaccine enhance protection compared to two doses. The safety, immunogenicity and vaccine efficacy data for three doses of the vaccine in children under five years of age are consistent with the data seen in adults, suggesting that a third dose will provide similar benefit in children.

In February 2022, the companies initiated a rolling submission for emergency use authorization (EUA) of their COVID-19 vaccine in children six months to under five years of age, following a request by the US. Food and Drug Administration (FDA). At that time, a two-dose series was determined to be well-tolerated in this age group. Pfizer and BioNTech plan to submit these new safety, immunogenicity, and vaccine efficacy data on three doses to its rolling US EUA application this week (as reported on May 23, 2022), with submissions to regulators globally to follow.

Source: Pfizer and BioNTech


Novavax Files for EU OK of COVID-19 Vaccine Booster in Adults
Novavax, a Gaithersburg, Maryland-based vaccine company, has submitted a request to the European Medicines Agency (EMA) to expand the conditional marketing authorization (CMA) of Nuvaxovid, its COVID-19 vaccine, in the European Union (EU) as a homologous and heterologous booster dose for individuals aged 18 and over.

The European Commission granted CMA in December 2021 for Nuvaxovid in individuals aged 18 and over, and Novavax filed for the expanded CMA for use in adolescents aged 12 through 17 in March 2022.

Source: Novavax