AstraZeneca’s COVID-19 vaccine has been granted conditional marketing authorization (CMA) in the European Union (EU) for active immunization to prevent COVID-19 caused by SARS-CoV-2, the virus that causes COVID-19. The company also updated its supply plan to the EU.

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III program led by the University of Oxford. The CHMP recommends two doses of the vaccine, to be administered at a four- to 12-week interval in people aged 18 years and older. Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks (as reported on January 29, 2021).

AstraZeneca is working with the EU following the approval of a CMA for active immunization to begin across member states.

Separately, Swissmedic, the Swiss pharmaceutical regulatory agency, reported that a Swissmedic advisory body confirmed Swissmedic’s interim assessment that additional data are needed in its assessment for authorization of AstraZeneca’s COVID-19 vaccine. Swissmedic said data currently available do not point to a positive decision regarding benefits and risks. To obtain a conclusive assessment, the agency said that the company needs to submit additional efficacy data from a Phase III trial underway in North and South America, and the data will have to be analyzed. As soon as the results have been received, a temporary authorization according to the rolling procedure could be issued at short notice.

Supply to the EU

The President of the European Commission (EC), Ursula von der Leyen, provided an update on the supply of the vaccine to the EU following an announcement late last month (January 25, 2021) that deliveries of the vaccine to the EU would be reduced and delayed due to supply issues encountered by the company. “AstraZeneca will deliver 9 million additional doses in the first quarter (40 million in total) compared to last week’s offer & will start deliveries one week earlier than scheduled,” said the EC Commissioner in a January 31, 2021 tweet. “The company will also expand its manufacturing capacity in Europe.”

Last month (January 2021), the European Commission (EC) provided a statement regarding the delayed delivery of AstraZeneca’s COVID-19 vaccine to the EU, stating that the company intended to supply fewer doses than what had previously been agreed upon with the EC. In August 2020, the EC signed an agreement with AstraZeneca for the purchase of 300 million doses of its COVID-19 vaccine, with an option for a further 100 million doses, to be distributed on a population-based pro-rata basis.

Positive Phase III Results

In providing its latest data, AstraZeneca reported that the primary analysis of a Phase III clinical trials from the UK, Brazil and South Africa confirmed that it’s COVID-19 vaccine is safe and effective at preventing COVID-19. Results demonstrated vaccine efficacy of 76% after a first dose, with protection maintained to the second dose. With an inter-dose interval of 12 weeks or more, vaccine efficacy increased to 82%.

AstraZeneca says it continues to work with global regulatory authorities to support ongoing rolling reviews for emergency supply or conditional approval of the vaccine. AstraZeneca is also seeking emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.

New study evaluating AstraZeneca’s and Pfizer’s BioNTech vaccine together

The UK government launched a study to assess the immune responses generated if doses of the COVID-19 vaccines from AstraZeneca/University of Oxford and Pfizer/BioNTech are combined in a two-dose schedule.

Backed by £7 million ($9.6 million) of UK government funding, the study will determine the effects of using different vaccines for the first and second dose, for example, using Oxford University/AstraZeneca’s vaccine for the first dose followed by Pfizer/BioNTech’s vaccine for the second. The study will also gather immunological evidence on different intervals between the first and second dose for a mixed-vaccine regimen against control groups when the same vaccine is used for both doses.

The 13-month study will monitor the impact of the different dosing regimens on patients’ immune responses, which have the potential to be higher or lower than from the same dose regimen. Initial findings are expected to be released in the summer (summer of 2021).

Source: AstraZeneca (authorization), Swissmedic, AstraZeneca (Phase III results), EC President, and UK government