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The first participants, both previously vaccinated and unvaccinated, receive AstraZeneca’s new COVID-19 variant vaccine AZD2816.
The first patients in a Phase II/III trial have received doses of AstraZeneca’s AZD2816—a COVID-19 variant vaccine—to assess the safety and immunogenicity of the vaccine against the SARS-CoV-2 virus, the company announced in a press statement on June 27, 2021.
Both previously vaccinated and unvaccinated adults will participate in the trial, which will recruit approximately 2250 participants across the United Kingdom, South Africa, Brazil, and Poland.
Individuals who have been fully vaccinated with Vaxzevria or an mRNA vaccine will receive AZD2816 at least three months after their last injection. Non-vaccinated individuals will receive two doses, four or 12 weeks apart; or the variant vaccine will be given as a second dose following a first dose of Vaxzevria four weeks apart, the company reported in a statement.
AZD2816 was developed using the same adenoviral vector platform as Vaxzevria. In addition, the spike protein had minor genetic alterations based on the Beta (B.1.351, South African) variant, the company reports.
“It is important we continue to stay ahead of genetically distinct variants of the coronavirus,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D in a press statement. “AZD2816 should help broaden individuals’ immune response against emerging variants of concern.”
Initial findings for the trial are expected later in 2021. AZD2816 will be assessed in an expedited regulatory pathway as a potential next-generation booster, the company reported.