European Medicines Agency recommends EU Approval for AstraZeneca vaccine By Investing.com

By Samuel Indyk

Investing.com – The European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for AstraZeneca PLC (LON:AZN)’s vaccine to prevent Covid-19 in people from 18 years of age. The EMA added that their scientific experts considered the vaccine can be used in older adults.

The agency’s human medicines committee (CHMP) assessed that the vaccine and said it meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.

OLDER POPULATION

There had been some concern that the EU would not recommend the vaccine be taken by those over the age of 65. “There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group,” the EMA said in a statement. “However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults.”

EFFICACY

The agency based their calculation of the efficacy of the vaccine on the results from two studies, the COV002 study (based in UK) and the COV003 study (based in Brazil). The other two studies involved in the clinical trial had fewer than six Covid-19 cases in each which was not enough to measure the preventative effect of the vaccine.

“These [studies] showed a 59.5% reduction in the number of symptomatic Covid-19 cases in people given the vaccine (64 of 5,258 got Covid-19 with symptoms) compared with people given control injections (154 of 5,210 got Covid-19 with symptoms),” the EMA said. “This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.”

GERMANY

The previous day, German Health Authorities issued a draft recommendation to should not be used in over-65s. The Robert Koch Institute – Germany’s federal public health agency – said there was insufficient data in those over 65 to ascertain how effective the vaccine would be.

This followed a story in Handelsblatt earlier in the week that suggested the vaccine was unsafe in those over 65, saying it had only 8% efficacy. A statement by the German health ministry later clarified that the publication had mixed up the efficacy rate with the number of over 65s in the trial.

PRODUCTION

There are still question marks over production and supply of the vaccine to EU member countries. The EU are vocally unhappy with AstraZeneca, alleging they have reneged on contracts for supply of the vaccine. However, AstraZeneca came out fighting, saying that the supply problems were a fault of the EU and the time it took to agree a contract. For context, the UK agreed a contract a full three months before the European Union and AstraZeneca say that the teething problems related to production were ironed out in the early part of the process.

The drug company had previously said it would have to cut Q1 supplies to the bloc by 60% but today reportedly offered the EU more than 8 million more doses of its vaccine this quarter. AstraZeneca CEO Pascal Soriot previously said there were no legal obligations to deliver on a precise timescale because it had only committed to supply under a “best-effort” clause. The European Union today published the contract, in order to be transparent, which they allege contained “binding orders”. However, large sections – including those on pricing and guaranteed delivery dates – have been blanked out and redacted.