View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
January 29, 2021updated 01 Feb 2021 9:43am

EMA approves AstraZeneca/Oxford Covid-19 vaccine

The European Union (EU)’s healthcare regulator the European Medicines Agency (EMA) has granted AstraZeneca (AZ) and the University of Oxford conditional marketing authorisation for their two-dose Covid-19 vaccine.

By Allie Nawrat

The European Union (EU)’s healthcare regulator the European Medicines Agency (EMA) has granted AstraZeneca (AZ) and the University of Oxford conditional marketing authorisation for their two-dose Covid-19 vaccine.

Free Whitepaper
img

What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

The decision was based on an assessment by the EMA’s Committee for Medicinal Products for Human Use of the vaccine’s efficacy and safety data. This included results from four clinical trials carried out in the UK, Brazil and South Africa in a total of 24,000 participants.

This brings the total number of emergency-approved Covid-19 vaccines in the EU to three. The EMA granted conditional marketing authorisation to Pfizer and BioNTech’s and Moderna’s vaccines in late December and early January respectively. UK regulator the Medicines and Healthcare products Regulatory Agency has approved the same three vaccines but approved the AstraZeneca/Oxford jab at the end of December.

EMA executive director Emer Cooke commented: “With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA [European economic area] member states to combat the pandemic and protect their citizens.

“As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”

AstraZeneca CEO Pascal Soriot said: “Today’s recommendation 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 hospitalisations.”

Professor Andrew Pollard, director of the AZ vaccine’s original developer the Oxford Vaccine Group and chief investigator of the Oxford vaccine trials Professor Andrew Pollard stated: “The recommendation by the EMA is an important milestone in extending access to the Oxford/AstraZeneca vaccine in our region and providing further endorsement that, after the rigorous scrutiny of regulators, the vaccine can be used to help protect populations from the coronavirus pandemic.”

The EMA decided to approve the AstraZeneca/Oxford vaccine for all adults aged over 18s. This comes within a day of the German healthcare regulator the Robert Koch Institute stating that in Germany the AstraZeneca/Oxford vaccine should only be used in adults aged under 65.

The Robert Koch Institute believes there was insufficient data to determine how effective the vaccine is in over-65s. As reported by the Guardian, AstraZeneca has responded that the reason why there were lower numbers of over-65s in their trials is because they were recruited later as the researchers wanted to make sure the vaccine was safe before administering it to their age group.

The approval comes in the midst of a public row between the EU and AstraZeneca regarding Covid-19 vaccine supply shortages.

Related Companies

Free Whitepaper
img

What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology