EMA recommends AstraZeneca Covid-19 vaccine for authorisation in the EU

The European Medicines Agency (EMA) said on January 29 that it had recommended granting a conditional marketing authorisation for AstraZeneca’s vaccine against Covid-19 in people from 18 years of age. This is the third Covid-19 vaccine that EMA has recommended for authorisation.

The EMA said that its human medicines committee (CHMP) had thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission.

This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns, the agency said.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” EMA executive director Emer Cooke said.

“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.”

Combined results from four clinical trials in the United Kingdom, Brazil and South Africa showed that Covid-19 Vaccine AstraZeneca was safe and effective at preventing Covid-19 in people from 18 years of age, the EMA said.

These studies involved around 24 000 people altogether. Half received the vaccine and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection.

The safety of the vaccine has been demonstrated across the four studies, the EMA said. However, the agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil).

The other two studies had fewer than 6 Covid-19 cases in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given between four and 12 weeks after the first, the agency concentrated on results involving people who received this standard regimen.

These showed a 59.5 per cent reduction in the number of symptomatic Covid-19 cases in people given the vaccine (64 of 5258 got Covid-19 with symptoms) compared with people given control injections (154 of 5210 got Covid-19 with symptoms). This means that the vaccine demonstrated around a 60 per cent efficacy in the clinical trials.

Most of the participants in these studies were between 18 and 55 years old. 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.

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. More information is expected from ongoing studies, which include a higher proportion of elderly participants.

Covid-19 Vaccine AstraZeneca is given as two injections into the arm, the second between four to 12 weeks after the first.

The most common side effects with Covid-19 Vaccine AstraZeneca were usually mild or moderate and got better within a few days after vaccination.

The most common side effects are pain and tenderness at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea.

The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the  EU pharmacovigilance system and additional studies by the company and by European authorities, the EMA said.

Meanwhile, following the renewed request from the European Commission on January 27, AstraZeneca agreed to publish the redacted contract signed between the two parties on August 27.

“The Commission welcomes the company’s commitment towards more transparency in its participation in the rollout of the EU Vaccines Strategy,” the EC said.

“Transparency and accountability are important to help build the trust of European citizens and to make sure that they can rely on the effectiveness and safety of the vaccines purchased at the EU level.”

The Commission said that it hopes to be able to publish all contracts under the Advance Purchase Agreements in the near future.

The contract published on January 29 contains redacted parts pertaining to confidential information such as details of invoices. The AstraZeneca contract is the second one to be published, after CureVac agreed to publish the Advance Purchase Agreement with the European Commission.

In a separate statement, the European Commission said that in an effort to ensure timely access to Covid-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU, it had today put in place a measure requiring that such exports are subject to an authorisation by member states.

European Commission President Ursula von der Leyen said: “The pandemic is having devastating effects in Europe and all around the world. Protecting the health of our citizens remains our utmost priority, and we must put in place the necessary measures to ensure we achieve this.

“This transparency and authorisation mechanism is temporary, and we will of course continue to uphold our commitments towards low and middle income countries,” Von der Leyen said.

This implementing act, adopted by urgency procedure and published on January 29, provides for authorisations of exports outside the EU of Covid-19 vaccines until the end of March 2021. This scheme only applies to exports from companies with whom the EU has concluded Advance Purchase Agreements.

Based on the previous experience with a similar measure on personal protective equipment in Spring 2020, the Commission will assist member states in setting up the relevant mechanism to ensure a smooth and coordinated implementation of the regulation, the statement said.

“This measure is targeted, proportionate, transparent and temporary. It is fully consistent with the EU’s international commitment under the World Trade Organization and the G20, and in line with what the EU has proposed in the context of the WTO trade and health initiative,” the Commission said.

“Committed to international solidarity, the EU excluded from this scheme vaccine supplies for humanitarian aid or destined to countries under the COVAX facility, as well as our neighbourhood,” it said.

(Photo: pixnio)

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