What are the side effects of previously approved Covid-19 vaccines? How long does the immune protection that vaccines can guarantee? Can immunocompromised patients receive the vaccine? Are vaccines equally effective even in people of different ethnicity or gender? How do I know if the side effects are caused by the vaccine?

Word guide for EMA in this past year has been and continues to be “transparency”. With an online site entirely dedicated to the pandemic of Covid-19 has made accessible a lot of information related to the development, approval and safety of vaccines against Covid-19. But the agency has not limited itself to information, it has created a real communicative channel with patients, stakeholders and citizens of the European Union, gathering questions and concerns from more or less institutional channels: Dialogues with public health authorities and general practitioners, Questions and Answers at public events, social media analysis.

As a European citizen, I attended one of the last events organised by EMA on 08 January 2021: “Public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU”. The event focused on the two anti-covid-19 vaccines so far approved: “Comirnaty” (Biontech/ Pfizer) and “COVID-19 Modern Vaccine” and was intended to explain the basis for their approval, clarify how their safety will be guaranteed, provide information on the roles of the European Commission and national public health authorities in their distribution. Four speakers followed: Harald Enzmann (Chair of Committee for Medicinal Products for Human Use – CHMP), John F. Ryan (Director of Public Health European Commission), Nikolai C. Brun (Chief Medical Officer of Danish Medicines Agency), Sabine Straus (Chair of Pharmacovigilance Risk Assessment Committee – PRAC) and anyone who had the opportunity to submit an application, even me.

The registration of the event, as well as the agenda and presentations of the speakers, were published on the EMA website, so they can be consulted by everyone at any time. So I decided to include in this article those points that I was most curious about, aware that each of us will then be able to consult the complete material independently. To this end, I also suggest the consultation of the material related to a previous event focused on processes for the development, evaluation, approval and monitoring of the safety of Covid-19 vaccines in the European Union: “Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU”.

How was the effectiveness of approved Covid-19 vaccines studied?

For Comirnaty clinical trials involved about 44,000 volunteers, for the Moderna vaccine 30,000. Half the patients received the vaccine, the other half a placebo and none of the participants knew if they would receive the vaccine or the placebo. The studies aimed to identify which of the participants who had developed symptoms from Covid-19 had been given the vaccine or placebo. Here are some numbers: for Comirnaty 18,198 people received the vaccine and among these 8 people developed symptoms from Covid-19, in 18,325 they received the placebo and 162 they developed symptoms of the disease. For the Moderna vaccine 14,134 people received the vaccine and among these 11 people developed symptoms from Covid-19, in 14,073 received placebo and 185 have developed symptoms of the disease.

How long does the immune protection that vaccines can guarantee last?

In line with the transparency approach that EMA has adopted, the answer to this question has been: at the moment it is not known how long the protection provided by these vaccines will last. Persons vaccinated during the clinical trial will continue to be monitored for at least two years in order to gather more information on the duration of the immune protection that vaccines can provide.

Are vaccines equally effective in people of different ethnicity or gender?

Clinical studies included people of different ethnicity and gender, for all these subpopulations the effectiveness of vaccines has been maintained at high levels.

What information do we not know about approved Covid-19 vaccines?

The duration of immune protection guaranteed by vaccines, the effectiveness on special populations (immunocompromised patients, children, pregnant women), the effectiveness in preventing asymptomatic cases of the disease. For this purpose, several clinical studies promoted by the manufacturers but also independent clinical studies are in progress or will be initiated shortly to provide further information.

How do I know if the side effects are caused by the vaccine?

The safety requirements demanded by Covid-19 vaccines are the same as those required for all others. Vaccines are approved by the European Medicines Agency only if the benefits they bring outweigh the risks to which you are subjected in the event that you contract the disease. The system of surveillance of the safety of vaccines and in general of every drug in Europe is known as “EU Pharmacovigilance system”. This system includes well-established analytical techniques to assess whether or not a side effect is caused by taking the drug. Once it is concluded that the side effect was actually caused by the drug, this is reported on the package leaflet. The leaflets of the vaccines against Covid-19 have been published in 24 languages and are available at https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty and https://www.ema.europa.eu/en/medicines/human/summaries-opinion/covid-19-vaccine-moderna.

What are the strategies put in place by the European Commission to facilitate the process of authorisation and supply of anti-covid-19 vaccines?

The main strategies put in place by the European Community are two: signing of the purchase agreements “Advance Purchase Agreements (APA)” with manufacturers to ensure a sufficient supply of vaccines against Covid-19; speed up, where possible, the development, authorisation and availability of vaccines by the European regulatory framework. In addition to these two main measures, the European Community has also implemented transversal strategies: an example, warn – through a statement dated 15 October 2020, over two months before the authorization of the first vaccine against Covid-19 – all Member States of the European Community on what would have been the key elements to be put in place to ensure an effective vaccination strategy (the capacity of health services in terms of facilities, equipment and staff; the affordability of the vaccine; the capacity to distribute vaccines with different transport and storage needs; the organisation of a clear communication campaign on the benefits, risks and importance of vaccinating against Covid-19).

What are the strategies put in place by the member states of the European Community to ensure an effective vaccination campaign against Covid-19? 

EMA has listed several strategies that have been or will be adopted by Member States to ensure an effective vaccination campaign: many Member States plan to use vaccination services and existing staff reserves, many will call national or European tenders for the storage of vaccines, most have an information system or other type of register and are updating it to process data on vaccination against Covid-19. Most Member States will offer the vaccine free of charge, but not all! EMA has decided not to publicly declare which countries or countries intend to sell it to the population rather than to cover its costs with public funds.

What are the main concerns identified by the European Commission regarding Covid-19 vaccines?

Among the various points that have been a reason for discussion among the population brought back to the European Community by representatives of member states (the safety and effectiveness of vaccines, the speed at which they were developed, etc.) curiously there is also the country of origin of the manufacturer. For one or more member states of the European Union this has been a cause for concern.

The presentation was followed by a session of comments and questions from the audience to which a panel of EMA experts could answer directly. A question to Marco Cavaleri (Head of Biological Health Threats and Vaccines Strategy) I was very curious: “Now that the first vaccines against Covid-19 are available not only at European level but also worldwide, do you think it will be more difficult to find volunteer participants to enlist in future clinical trials? The volunteers will find themselves faced with the dilemma: do I now vaccinate or do I volunteer as a volunteer for the clinical study aware that I can receive a placebo and run a high risk of contracting the disease?” The expert’s very honest answer was that despite this awareness it is hoped that clinical trials will continue as long as possible.