AstraZeneca vaccine gets green light from European regulators

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AstraZeneca’s Covid-19 vaccine has been granted a conditional marketing authorization (CMA) in the European Union (EU) for active immunization t in individuals 18 and older.

The vaccine candidate is expected to go before regulators in the U.S., perhaps in the spring.AstraZeneca has headquarters, logistics, and manufacturing operations in northern Delaware.

Following a 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 Phase III program’s primary analysis by the University of Oxford. Additional data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks.

The release announcing the EU OK made no mention of the overall effectiveness of the AZ vaccine. Estimates have varied with an odd finding that one and a half doses could be 90 percent effective. Trials determine if that finding holds up are continuing, but two doses the recommendation for now.

The CHMP recommends two doses of Vaccine AstraZeneca, formerly AZD1222, to be administered at a four- to the 12-week interval in people aged 18 years and older. This dosing regimen was shown in clinical trials to be safe and effective, with no severe cases and no hospitalizations more than 14 days after the second dose.

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

AstraZeneca has been in dispute with the EU over the vaccine after shipments are expected to be lower than earlier estimates due to production issues.

Pascal Soriot, CEO said: “Today’s approval underscores the value of AstraZeneca’s Covid-19 vaccine, which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalizations. We are deeply grateful to Oxford University, participants in the clinical trials, and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans.”

AstraZeneca is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.

The vaccine can be stored, transported, and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings. The storage capability is a major advantage in getting vaccines to rural areas and developing countries.

COVID-19 Vaccine AstraZeneca was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the virus if it later infects the body.

CHMP’s recommendation was based on an analysis of 23,745 participants aged 18 years and older, accruing 232 symptomatic Covid-19 infections from the UK and Brazil Phase III trials conducted by Oxford University.

The safety data published so far is from over 20,000 participants enrolled across four clinical trials in the UK, Brazil, and South Africa. The publication in The Lancet confirmed that COVID-19 Vaccine AstraZeneca was well tolerated and that there were no serious safety events confirmed related to the vaccine. The participants were from diverse ethnic and geographic groups who were healthy or had stable underlying medical conditions.

In addition to the program led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enroll up to 60,000 participants globally.

The AstraZeneca COVID-19 vaccine has already been granted a CMA or emergency use in close to 40 countries, spanning four continents, including in the EU, several Latin American countries, India, Morocco, and the UK.

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