Brussels (Brussels Morning) Marketing approval for COVID-19 vaccines in the EU will be granted by 29 December for Pfizer and BioNTech, and 1 January for Moderna.
The announcement was made by the executive director of the European Medicines Agency’s (EMA) Emer Cooke, following a European Parliament hearing on COVID-19 vaccines, led by MEP Pascal Canfin MEP (Liste Renaissance).
The medicine agency held a public meeting today to “listen to concerns and questions from the public”, Cooke said, while “aspects of EMA’s scientific evaluation” were detailed by EMA’s Marco Cavaleri, Fergus Sweeney and Peter Arlett.
The online event provided a platform for patients’ representatives, consumers, industry, healthcare professionals and academia to voice their views on the rush for a vaccine to deal with the pandemic.
It came two days after the EMA suffered a cyber attack involving incognito access to the regulatory submission for the Pfizer and BioNTech’s COVID-19 vaccine candidate, which Cooke made reference to while addressing MEPs yesterday and the wider public today.
Market Authorisation
Cooke presented an overview of the status of the vaccines in the EU, alluding particularly to its market authorisation, which would allow vaccine distribution to the general public by the end of the year or early next year. However, last-minute changes may arise, she warned.
A total of four vaccines are under review, including those developed by AstraZeneca and Oxford University, and Janssen.
The EMA said that issues related to post-authorisation of the inoculations required strong collaboration between the agency, the European Centre for Disease Prevention and Control (ECDC) and national authorities.
Cooke said she wanted to “assure” the public that EMA’s scientific assessment “will be fully independent” based on the “strength of the scientific evidence of vaccines’ safety, quality and efficacy”.
“Authorisation will only be granted when the evidence convincingly shows that the benefits are greater than the risks of the vaccine”, added Cooke.
Transparency
During her presentation, EMA’s executive director reinforced the need for transparency when dealing with placement in the market of any COVID-19 vaccine.
Cooke said that “effective communication” was necessary to gain the trust of the public and said the agency would publish “the [vaccine’s] assessment report within three days of the Commission’s decision”.
According to her statement, all clinical trial results assessed by EMA will be available on its website. As an exception to the rule, she said, the vaccines’ risk management plans will also be published.
“We don’t just want to publish information, but to communicate better”, said Melanie Carr, head of EMA’s stakeholders and communication.
Side effects
However, Cooke said an approved vaccine would not be a “silver bullet” and advocated for social distancing measures to continue. “We know a lot more than we did six months ago, but we still have a lot to learn”, she cautioned.
When addressing EMA’s chief, MEP Margarita de la Pisa (ECR), raised concerns saying that “we don’t have time to know the long-term side effects” of the vaccines.
She further added that messenger RNA vaccines (mRNA) — such as that produced by Pfizer and BioNTech — may help “develop self-immune diseases”.
De la Pisa, a pharmacist by training, claimed that those more in need, including the immune-compromised, maybe the cluster suffering more from side effects and called on extra safety measures when dealing with these specific cases.
Patient and consumer representatives have also raised concerns over side effects during EMA’s public meeting today.
Rollout
On 8 December, the COVID-19 vaccine commenced rollout in the UK, despite disapproval from the European Parliament for not following EMA’s authorisation.
The UK government has explained the process that they believed justified the approval of the Pfizer and BioNTech vaccine.
Bahrain and Canada also started administering the vaccine shortly afterward. The EU will be the fourth market to have access to the jabs, which is expected to allow citizens to slowly return to a “normal” life.
