Summary of the EMA public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU

On Friday 8 January 2021 the European Medicines Agency (EMA) hosted an online, public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU.

The event focused on the key aspects of how the Moderna and Comirnaty (Pfizer/BioNTech) vaccines have been assessed, approved and will be rolled out across the EU.

The EMA took on board previous feedback that their stakeholder meetings should be more accessible to the public. Therefore, this meeting was developed with this in mind and used easy to understand language and went into more detail about areas that non healthcare professionals may not understand. Access the full meeting and all of the presentation slides.

The meeting was introduced by Emer Cooke, EMA Executive Director, and was chaired by Noel Wathion, EMA Deputy Executive Director.

Representatives discussed the approval and roll-out of COVID-19 vaccines in the EU:

  • Basis for the EU approval of new vaccines – Harald Enzmann (Chair of Human Medicines Committee: CHMP)
  • How the safety of the new COVID-19 vaccines will be monitored – Sabine Straus (Chair of Safety Committee: PRAC)
  • The European Commission’s role in the authorisation process and facilitation of roll-out vaccination – John Ryan (Director for Public Health, DG SANTE, EC)
  • Ongoing actions for roll-out vaccination at national level – Nikolai Brun (on behalf of Heads of Medicines Agencies)

There was then a public session with speakers and a panel of experts who included:

  • Melanie Carr (Head of Stakeholders and Communication Division, EMA)
  • Fergus Sweeney (Head of Clinical Studies and Manufacturing, EMA)
  • Peter Arlett (Head of Data Analytics and Methods, EMA)
  • Marco Cavaleri (Head of Biological Health Threats and Vaccines Strategy, EMA)

Here, we have summarised some key points from EMA that answer some questions ELF has received about COVID-19 vaccine development.


Q&A session with Prof. Anita Simonds, ERS President


On 15 December 2020, Professor Anita Simonds, European Respiratory Society President, held a question and answer session about vaccines. Her answers to the questions are below. If you have any more questions about COVID-19 vaccines then please send them to info@europeanlung.org

  • Why has the vaccine development been so quick when normal vaccine development can take 10 years?

    There are a few reasons why the COVID-19 vaccines have been produced more quickly than the normal production process for vaccinations.

    The initial design stage of the vaccine was quicker as existing information could be taken from work to find a vaccine for SARS and MERS – other forms of coronavirus.

    Also, once the smaller studies were completed suggesting that the COVID-19 vaccines would generate a response in the body to fight the virus, companies took the chance to start making the vaccine in bulk. This would not normally happen because of the financial risk. However, given the grave situation of a worldwide pandemic, governments across the world were prepared to order the vaccine and say they would pay for it. This risk was therefore taken on by the public through their governments, meaning that companies could begin manufacturing much sooner than usual, ready for the vaccine to be rolled out once the larger trials were completed.

    Another big change was that regulators usually wait until all phases of a vaccine trial have been completed so that they can review the evidence in one go. This time, companies have been providing data to the regulators throughout the process. They worked with them to ask what the regulator needed and delivered the data as the studies continued. This process of rolling feedback meant that regulators were in a much better position at the end of the trials to give an opinion straight away.

    All studies were done in a rigorous and robust way – the science is as good as normal and no corners were cut in the development of the vaccine.

  • What are the requirements for regulators to approve a vaccine?

    The main requirements are safety and efficacy – how safe the vaccine is and how effective it is. Companies also need to prove that each individual vaccine will be produced to the high standards seen in the trials.

    One reason the COVID-19 vaccine is so exciting is because of how effective it was in the trials – its efficacy. The Pfizer/BioNtech vaccine was shown to have a 90% efficacy, the Moderna vaccine had a 94.5% efficacy, while the Oxford University/AstraZeneca vaccine was 70%.

    Regulators usually aim for 50% efficacy for a vaccine. Sometimes vaccines that are used each year, such as the flu vaccine, can have much lower efficacy than this. The numbers of 70% and upwards are therefore very encouraging and better than many vaccine experts expected.

    It is worth remembering that looking at the overall efficacy number on its own can be misleading – all these trials provide information on how the vaccine performed in different subgroups. We know that the elderly are vulnerable to COVID-19 so looking at the efficacy in the over 70s is also important.

  • How do we know if there are any long-term side-effects of the vaccine?

    We only find out about the long-term effects of any vaccine once it is in general use in the population. The safety will be continuously monitored. Particular issues that are still to be considered are whether the vaccine is safe in pregnant or breastfeeding women, in people with severe illness and in children, and whether it interacts with other vaccines. There is no evidence yet that the vaccine is unsafe if you have already had COVID-19 or if it makes so-called long-COVID any worse.

  • Which countries will receive the vaccine first?

    Many countries have bought up supplies in advance – they have gambled and placed orders with different vaccines before regulators have approved them. The World Health Organization and Gavi – the vaccine alliance – have promised funding to low-income countries to ensure the vaccine will be distributed there at low-cost or no-cost. The Oxford University/AstraZeneca vaccine is the cheapest and easiest to distribute and when approved it will be provided cost-free to low-income countries.

  • Is there a European directive detailing who should get the vaccine first?

    There is no European directive telling countries who they should give the vaccine to first. This will be organised country by country, but most will likely prioritise the elderly, especially those in care homes, those with underlying conditions and front-line healthcare workers.

  • Will the development of the COVID-19 vaccine change the vaccine development process moving forwards?

    It is likely that vaccine development has now changed forever. We are already looking back and wondering how it could have taken this long. The big issue is the risk involved in the cost. Companies may only wish to produce a vaccine during a trial if the cost is covered by governments and this will depend on the seriousness of the issue.

  • Are we likely to be given a ‘vaccine passport’?

    This will be a decision taken by individual countries, or airline companies. All countries will have the ability to record on patient records when a person has received the vaccine, but it is uncertain at the moment whether they will be given anything, such as a card or passport, to confirm this has happened.

  • Is the vaccine better at protecting us compared with the antibodies we get from being infected with COVID-19?

    So far, the data suggests that the immune response generated from the vaccine is better than the immune response we get from being infected with COVID-19. This is particularly the case for older people – they are getting more antibodies from the vaccine than they appear to generate from fighting off the infection. As this is still a new disease, we don’t yet know if this will be the case long-term.

  • Do we need a percentage of the population to be vaccinated before we reduce other infection control measures such as social distancing and face masks?

    Many healthcare experts believe that our behaviour around infection control has changed forever. For example, people may feel more comfortable wearing face masks on crowded public transport, particularly if they have a cold. Measures such as face masks, hand washing and distancing can help stop the spread of all respiratory viruses and therefore these measures may always be useful, particularly in winter seasons.

    We don’t yet know what percentage of the population need to have immunity to COVID-19 before it becomes manageable. At the moment, if the vaccine roll-out continues as expected, we are likely to see some of the government-enforced restrictions easing from the middle of 2021 onwards.

  • Will the vaccine work with mutated versions of the virus?

    Viruses mutate, that’s what they do. These mutations won’t usually require a change in the vaccine as the part of the virus that the vaccines target is unlikely to change from a mutation. However, if this does happen, the vaccines that have been developed can be modified quickly if they need to target a new mutation. This happens every year with the flu vaccine.

EMA stakeholder meeting: how safe and effective vaccines are developed and authorised in the EU

On Friday 11 December, the European Medicines Agency (EMA) hosted an online stakeholder meeting on COVID-19: how safe and effective vaccines are developed and authorised in the EU.

At the meeting representatives from the EMA discussed how COVID-19 vaccines are developed, how they are evaluated and how safety is monitored. Presentations included:

  • Welcome and introductions – Emer Cooke (EMA Executive Director) and Noël Wathion (EMA Deputy Executive Director)
  • How COVID-19 vaccines are developed – Marco Cavaleri (Head of Biological Health Threats and Vaccines Strategy)
  • EU’s regulatory process for evaluation and approval of vaccines – Fergus Sweeney (Head of Clinical Studies and Manufacturing)
  • Safety monitoring of COVID-19 vaccines – Peter Arlett (Head of Data Analytics and Methods)
  • Transparency, engagement and communication – Melanie Carr (Head of Stakeholders and Communication).

 

During the second half patients, carers, consumers and citizens, industry, healthcare professionals and academics could present and ask questions to the EMA.

Here we have summarised some key points that answer some questions we at ELF have received about COVID-19 vaccine development.

Watch the full meeting and access the slides and other resources from the day 

EMA also have a COVID-19 vaccine key facts page which is a useful resource.

How do we know that the vaccines will be safe or effective for people with underlying conditions?

There has been an effort to include people with underlying conditions in the studies. Although the numbers are not yet known, there should be at least 1 in 10 people in the trials that have an underlying condition. Once the data are released, the EMA will be open about the number of people in the studies who had underlying conditions.

Women, pregnant people, the elderly, and people from marginalised groups are often less represented in clinical trials. Will the EMA take this into account when making decisions about the safety of the vaccine?

In each trial there should be around 1 in 4 people who are over 65. Women and people from marginalised groups should also be well represented. EMA will consider these factors in its decision when assessing the safety and efficacy of the vaccines. EMA will also ensure that this information is transparent and accessible.

As pregnancy is often part of the exclusion criteria for medical trials, more data are needed to understand the safety implications for pregnant people.

How have the studies looked for potential side-effects of the vaccine?

Participants in the trials will be followed up for a minimum of 6 weeks. Most side-effects happen within 4-6 weeks of having a vaccine. The trials will last up to a year to better understand the level of longer-term protection and side-effects.

Once the vaccines are released, there will be a robust monitoring plan for managing the safety of the vaccine. All new data about the vaccines will be monitored and assessed on a rolling basis. If there are concerns, then the conditions for the vaccine being available can be re-assessed. If the conditions are not met, then the vaccine can be withdrawn.

Other key messages:
  • The EMA has been very clear that safety will not be compromised, and that transparency is of utmost importance. It is important that everyone has enough information about the vaccines so they can understand them and the development process.
  • The safety requirements for COVID-19 are the same for any other vaccines and have not been lowered due to the pandemic.
  • The vaccines have been able to be developed so quickly due to a number of factors, including the pooling of resources and the overlapping of research timelines.
  • Vaccines are only approved if overall benefits outweigh the risks.
  • COVID-19 vaccine safety will be stronger with your participation – please report suspected side-effects.

A summary of the latest announcements, research and reaction from the European Respiratory Society President

Published: 9 December 2020

In the last few weeks, we have seen several encouraging announcements from companies working to develop vaccines to protect against COVID-19.

Which vaccines have demonstrated successful results so far?
  • The Pfizer/BioNtech vaccine has been shown to have an efficacy (how well a drug works under controlled and best-case conditions, such as in a trial) of 90%. It was tested on 43,000 people, with no safety concerns reported. Read the Pfizer and BioTech press release.
  • Moderna reported that their vaccine has an efficacy of 94.5%. They tested it in a trial involving 30,000 people. Half of them received the vaccine and half received a placebo (not medicine) injection. No significant safety concerns were reported. Read the Moderna study overview.
  • The Oxford University/AstraZeneca vaccine studies have shown a combined efficacy of 70% – this is from several different trials. One trial demonstrated 62% efficacy, and another in which the recipients received a half dose, followed by a full dose, showed 90% efficacy. Further research into the optimal dose will continue. In an earlier trial looking at the immune reaction from the vaccine, a high proportion of people developed antibodies including older individuals. Read the published data in Lancet.
What has been the reaction from leading respiratory experts?

President of the European Respiratory Society (ERS), Professor Anita Simonds, said: “These announcements are very encouraging in the fight against COVID-19 and ERS reiterates its support for the development of safe and effective vaccines that can prevent and protect against SARS-CoV-2 (the virus that causes COVID-19). Vaccines will play a very important role in controlling this virus alongside measures that are currently recommended to slow the spread, such as frequent hand washing, wearing a face covering and physical distancing.

She added: “Both efficacy and safety are important. For example, an efficacy of 50% means that there was a 50% reduction in the number of cases of symptomatic COVID-19 disease in people who received the vaccine, compared to those who did not. In other words, among those vaccinated half the people who would have got symptomatic disease did not get it. In fact, a vaccine with 50% efficacy or higher is usually accepted as highly effective by the regulators. But head-to-head comparisons of efficacy are not everything. We need to take into account whether severe cases were reduced, and also whether the vaccine can reduce transmission. It is also possible that some vaccines may work better in different groups of people such as the elderly, and those with other health conditions.

Safety has been extensively investigated, and no risks have been seen in the 6-week period of follow-up in the large trials. Further follow-up is important once the vaccines are rolled out, as any long-term effects can only be detected that way.

“There are now around 50 ongoing COVID-19 vaccine trials, 12 of which are at the phase 3 stage and are undergoing large-scale efficacy tests, so we are likely to see more reports like this in the coming months. We are all hopeful for a return to a more normal existence as the pandemic has been a very challenging time for everyone, but it is important to keep the reports in perspective, as they are based on announcements of interim analyses only.

“While there are some unanswered questions about these vaccines at present, it is impressive how rapidly scientists have worked to develop these potentially life-saving treatments. The ERS and all those interested in healthcare have an important role to play in disseminating accurate information on the vaccines to help develop ‘vaccine confidence’ in both the general public and patients”.

What steps are still needed?

Any vaccine that is found to be successful in a trial must also be approved for use by regulatory bodies. In the European Union, the European Medicines Agency (EMA) will review all potential vaccines to look at how effective and how safe they are. They must approve any vaccine before it can be offered to the general population. Find out more about how the EMA approves vaccines.

The UK regulating body, Medicines and Healthcare products Regulatory Agency (MHRA), approved the Pfizer/BioNtech vaccine on 2 December and the roll-out to the public began on 8 December. Other countries are expected to announce their decisions in the coming weeks.

Rolling out a vaccine across the population will be difficult to organise. Vaccines must be developed and distributed on a huge scale to protect populations across the world. Some of these vaccines also need to be stored at very cold temperatures; this can be a problem for the healthcare centres who will offer the vaccinations.

Who will receive the vaccine once approved?

If any vaccine is approved, it will be up to each country to decide who to give the vaccine to first.

The most likely people to receive the vaccine first will be from vulnerable groups, such as:

  • elderly people (especially those living in care homes),
  • people with pre-existing conditions, including certain lung conditions, and
  • healthcare workers, as they come into contact with vulnerable people.
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