Positive results from a preliminary analysis of an ongoing safety and immunogenicity trial (D7220C00001) showed that Vaxzevria (ChAdOx1-S [Recombinant]), when given as a third dose booster, increased the immune response to Beta, Delta, Alpha and Gamma SARS-CoV-2 variants, while a separate analysis of samples from the trial showed increased antibody response to the Omicron variant.
The results were observed among individuals previously vaccinated with either Vaxzevria or an mRNA vaccine.
A separate Phase IV trial reported in a preprint with The Lancet on SSRN showed that a third dose of Vaxzevria substantially increased antibody levels following a primary vaccine series with CoronaVac (Sinovac Biotech).(1)
These data add to the growing body of evidence supporting Vaxzevria as a third dose booster irrespective of the primary vaccination schedules tested.(2,3) The Company is submitting these additional data to health authorities around the world given the urgent need for third dose boosters.
Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Vaxzevria has protected hundreds of millions of people from COVID-19 around the world and these data show that it has an important role to play as a third dose booster, including when used after other vaccines. Given the ongoing urgency of the pandemic and Vaxzevria's increased immune response to the Omicron variant, we will continue to progress regulatory submissions around the world for its use as a third dose booster."
Professor Sir Andrew J Pollard, chief investigator and director of the Oxford Vaccine Group at the University of Oxford, said: "These important studies show that a third dose of Vaxzevria after two initial doses of the same vaccine, or after mRNA or inactivated vaccines, strongly boosts immunity against COVID-19. The Oxford-AstraZeneca vaccine is suitable as an option to enhance immunity in the population for countries considering booster programmes, adding to the protection already demonstrated with the first two doses."
The D7220C00001 safety and immunogenicity trial showed that Vaxzevria continued to be generally well tolerated. Further analyses from the trial are expected in the first half of 2022.
Previous studies support Vaxzevria as a third dose booster as part of a homologous or heterologous schedule.(2,3) In a sub-analysis from the COV001 and COV002 trials, a third dose of Vaxzevria given at least six months after a second dose significantly boosted antibody levels and maintained T cell response.(2) It also resulted in higher neutralising activity against the Alpha, Beta, and Delta variants, compared with a two-dose regimen.(2) The COV-BOOST trial also showed that a third dose booster of Vaxzevria induced significantly higher immune responses compared with controls against the Delta variant and original strain following a primary vaccine series of Vaxzevria or Pfizer BioNtech (BNT162b2).(3)
About D7220C00001 Trial
D7220C00001 is an ongoing partially double-blind, randomised, multinational, active-controlled trial in both previously vaccinated and unvaccinated adults to determine the safety and immunogenicity of Vaxzevria and AZD2816, a vaccine developed for the prevention of COVID-19 caused by the Beta variant of the SARS-CoV-2 virus.(4)
Immunogenicity data for the preliminary analysis were from samples taken 28 days after the third dose booster vaccination. Individuals included in the preliminary analysis of the trial had been fully vaccinated with two doses of Vaxzevria (n=700), or an mRNA-based vaccine (n=600), prior to being given a third dose booster vaccination of Vaxzevria or AZD2816 at least three months after their last injection.
About RHH-001 Phase IV Trial
The Phase IV randomized, single-blind, two-centre trial assessed the safety and immunogenicity of a third heterologous booster dose of either Vaxzevria, an mRNA vaccine (BNT162b2, Pfizer/BioNTech), or a recombinant adenoviral vectored vaccine (AD26.COV2-S, Janssen), compared with a third homologous booster dose of CoronaVac in Brazilian adults who had received two doses of CoronaVac six mont...
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