#16,160
The debate over the current need for - and even the advisability of - rolling out COVID booster vaccines continues today with a joint statement issued by ECDC and EMA (European Medicines Agency) which finds `no urgent need' for booster shots at this time (except for those with severely weakened immune systems), and instead urges continued outreach to roughly 33% of eligible European vaccine recipients who are not yet fully vaccinated.
This is in stark contrast to Israel's rollout of booster shots to those over the age of 60 in late July, and to the announced intentions of the HHS to begin offering COVID Booster Shots for ". . . all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose."
In all fairness, there is probably no `right decision' here. Both sides cite valid points, and both are basing their policy recommendations on limited, and sometimes conflicting, information.
- Getting everyone fully vaccinated first sounds good, but that could literally take years, and many will ultimately refuse the shot.
- Meanwhile, if we let people's vaccine protection wane, we could open ourselves up to renewed waves of infection, and the possibility of new variants emerging.
It is, in many ways, a Catch-22. And I honestly have no idea which course is likely to be the lesser of two evils. This is once again a reminder that a vaccine - while a powerful tool in a pandemic - is not a complete solution, and was never going to be a panacea for this (or any) pandemic.
Making their case, we have the ECDC and EMA press release, followed by a link to the ECDC Technical Report, and its executive summary.
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
Press release
2 Sep 2021
Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.
Evidence on vaccine effectiveness and duration of protection shows that all vaccines authorised in the EU/EEA are currently highly protective against COVID-19-related hospitalisation, severe disease and death, while about one out of three adults in the EU/EEA over 18 years is still currently not fully vaccinated.
In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course. To complement vaccination efforts, it is also crucial to continue applying measures such as physical distancing, hand and respiratory hygiene, and using face masks where needed, in particular in high-risk settings such as long-term care facilities or hospital wards with patients at risk of severe COVID-19.
It is important to distinguish between booster doses for people with normal immune systems and additional doses for those with weakened immune systems. Some studies report that an additional vaccine dose can improve the immune response in immunocompromised individuals, such as organ transplant recipients whose initial responses to vaccination were low. In such cases, the option of administering an additional dose should be considered already now. Consideration could also be given to providing an additional dose, as a precautionary measure, to older frail individuals, in particular those living in closed settings such as residents of long-term care facilities.
The European Medicines Agency (EMA) is currently assessing data on additional doses and will consider whether updates to the product information are appropriate. EMA will also be assessing data on booster doses.
While EMA assesses relevant data, Member States may consider preparatory plans for administering boosters and additional doses.
Advice on how vaccinations should be given remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State. These bodies are best placed to take into account the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems.
The ECDC will update its technical report as ECDC and EMA continue to work together to collect and assess data that are becoming available on boosters and additional doses. Close monitoring of vaccine effectiveness data and breakthrough infections, particularly among vulnerable groups at risk of severe COVID-19 and among those living in closed settings, should be continued. In the meantime, Member States need to prepare for possible adaptations to their vaccination programmes should a substantial decrease in vaccine effectiveness be noted in one or more population groups.
Read the report
Publication
Interim public health considerations for the provision of additional COVID-19 vaccine doses - 1 Sep 2021
TECHNICAL REPORT I1 September 2021
Executive summaryKey messages
- Providing all eligible individuals with the recommended dose regimen should remain the current priority for COVID-19 vaccination programmes in the European Union/European Economic Area (EU/EEA).
- It is important to distinguish between ‘booster’ doses for people who responded adequately to primary vaccination and additional doses for those with weakened immune systems who did not respond adequately. Booster doses are given to vaccinated people (i.e. those who have completed a primary series of COVID-19 vaccination) to restore protection after it would have waned. On the other hand, additional doses as part of a primary vaccination series may be given to people with severely weakened immune systems, as they may not achieve an adequate level of protection from the standard primary vaccination.
- When assessing the need for possible booster doses of COVID-19 vaccine from the public health perspective, it is important to keep in mind the main objective of the vaccination strategy (i.e. preventing severe cases of COVID-19). Vaccine effectiveness against severe disease should preferably be chosen as the primary outcome of interest for assessing whether there is a clear need for a booster dose in specific groups.
- The available evidence at this time regarding ‘real world’ vaccine effectiveness and the duration of protection shows that all vaccines authorised in the EU/EEA are currently highly protective against COVID-19-related hospitalisation, severe disease and death, suggesting there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population.
- The option of administering an additional vaccine dose to people who may experience a limited response to the primary series of COVID-19 vaccination, such as some categories of immunocompromised individuals (e.g. solid organ transplant recipients), should already be considered now. This is to be seen as an extension of the primary vaccination series for these specific groups, and not as a booster. Consideration could also be given to providing an additional dose as a precautionary measure to older frail individuals, in particular those living in closed settings (e.g. residents of long-term care facilities).
- Full vaccination against COVID-19 of all eligible family contacts and close contacts, including professionals providing care, of immunocompromised and vulnerable individuals should also be considered.
- Close monitoring of vaccine effectiveness data and breakthrough infections, particularly among vulnerable groups at risk of severe COVID-19 and among those living in closed settings, should be continued, and decisions adapted accordingly, should a substantial decrease in effectiveness be noted in one or more population groups.
- When in contact with individuals at risk of severe disease, physical distancing (when applicable), the wearing of face masks (especially when physical distancing cannot be kept), and hand and respiratory hygiene remain pivotal measures for reducing the risk of SARS-CoV-2 transmission. These non-pharmaceutical interventions should always complement vaccination, in particular in high-risk settings such as long-term care facilities or hospital wards with patients at risk of severe COVID-19.
- More solid data are needed to inform future policies on booster doses. Knowledge gaps are particularly related to the appropriate correlate of protection to consider for the different population groups and the time from primary vaccination series until a booster dose should be given, and duration of immunity according to e.g. different age and risk groups, vaccine product, dosing interval, variant of concern (VOC), and homologous/heterologous schedule. Prospective vaccine effectiveness studies, as well as surveillance of breakthrough infections in the general population and in specific groups, are needed to answer these questions.
- The benefits and risks of possible booster doses need to be clearly outlined and compared. Benefits may include increased protection against severe disease, mild-to-moderate disease, post COVID-19 condition (often called ‘long COVID’), SARS-CoV-2 infection, and virus transmission. Risks include possible safety concerns and public health implications (e.g. impact on vaccine confidence and uptake, global availability of vaccines).
- Communication about possible additional vaccine doses should be carefully considered and delivered in a transparent, proactive, and clear way to avoid affecting vaccine confidence. The distinction between strengthening the response to primary vaccination series, for example in immunocompromised individuals, and boosters for waning immune response or vaccine escape, should be clearly made.
- In the context of many countries outside of the EU/EEA still struggling to receive and administer enough vaccine doses to their populations, special consideration should be given to the current global shortage of COVID-19 vaccines, which could be further worsened by the administration of booster COVID-19 vaccine doses for the general population in EU/EEA countries.
