Source : 'The Pink Sheet'
The European Commission is working on ways of fairly allocating future COVID-19 vaccines among EU member states and says plans are under way to establish enhanced safety monitoring for any vaccines placed on the market.
The commission also urges public authorities to carry out studies of vaccine effectiveness and safety “independent of industry interests, make sure any new post-marketing information is gathered and assessed as quickly as possible, and take steps to counter vaccine misinformation".
Other ideas being developed include flexibility on labeling and packaging to speed up vaccine deployment, identifying priority populations for vaccination, and creating a European equivalent of the US Biomedical Advanced Research and Development Authority (BARDA) to work on biomedical countermeasures for emergency threat situations.
The developments are outlined in a communication issued by the commission on “Preparedness for COVID-19 vaccination strategies and vaccine deployment.” It comes as more than four million coronavirus cases have been reported in the EU/European Economic Area and the UK, with nearly all countries involved seeing high levels or sustained increases in their 14-day notification rates.
“While non-pharmaceutical interventions are crucial in slowing down the spread of the coronavirus, they are not able to control it sustainably” and “now is not the moment to let down our guard,” the commission says. The development and swift deployment of safe and effective vaccines remains "an essential element in the management of and eventual solution to the public health crisis.”
The communication is directed at the EU Council and the European Parliament. It is a follow-up to the EU Strategy for COVID-19 vaccines, which was published in June and included the possibility of signing advance purchase agreements (APAs) to ensure sufficient vaccine supplies in the EU.
Since the strategy was published, the commission has signed contracts for vaccine supplies with AstraZeneca PLC (300 million doses), Sanofi/GlaxoSmithKline plc (300 million doses) and most recently Johnson & Johnson (200 million doses).
In its communication, the commission makes the case for securing a broad portfolio of vaccine candidates with different technological approaches to maximize the chances of finding a successful product. It encourages all member states to “participate in the full portfolio,” even though this will require additional funding. “That is why all member states are invited to top up the budget of the Emergency Support Instrument.”
Looking at specific actions being taken on vaccine deployment, the commission says it is putting in place a “coordinated approach” to the distribution of vaccines across the EU, noting that an allocation methodology has been agreed with the member states to ensure they all have equal access to the available doses based on their population size.
The APAs include provisions on the equal distribution of vaccine doses to the members states based on a “pro-rata population distribution key.” Once available and authorized at EU level, the commission says, all member states will have access to COVID-19 vaccines at the same time. "The overall number of vaccine doses will be limited during the initial stages of deployment and before production can be ramped up.”
The commission also notes the importance of follow-up once vaccines are made available. It says that the European Medicines Agency and EU and international partners are establishing specific enhanced safety monitoring activities for COVID-19 vaccines to make sure that any new post-marketing information is “centrally collected, identified and evaluated as quickly as possible” and that appropriate regulatory action is taken where necessary.
“This calls for a European network of vaccine clinical trials, focusing on phase 3 (efficacy and safety) and phase 4 (continuing assessing safety and efficacy post introduction) trials,” it declares. “Member states and public health authorities should prepare to undertake studies, independent of industry interests, of vaccine effectiveness and safety,” it adds.
Additional monitoring activities are also being undertaken by the European Centre for Disease Prevention and Control (ECDC) and the EMA on the effectiveness, coverage, safety and impact of COVID-19 vaccines.
Making a vaccine available is one thing; ensuring the member states have the resources to carry out vaccination programs is another. Member states, the communication says, should make sure they are able to deliver and distribute vaccines “in an ordered manner, within a given timeframe and in line with a rapidly changing epidemiological situation.”
It also suggests vaccines should be provided free to recipients where possible. Vaccination services “should be made easily accessible for target populations, both in terms of affordability – member states are encouraged to consider providing COVID-19 vaccines free of charge – and with physical proximity.”
Vaccination services are advised that infrastructure planning should take account of the fact that the vaccines will have different characteristics and storage/transport requirements. For example, some vaccines will have specific temperature requirements (as low as –70 degrees celsius in some cases) and that differences in vaccine characteristics “are likely to translate into different sizes of packages and specific transport needs.”
Member states should therefore "review arrangements, bearing in mind that cold chains, cooled transport options and both peripheral and central storage capacity may need to be increased.”
Who should get the vaccines first? That is a question health authorities around the world will be working on. For its part the commission has drawn up an unranked table of priority groups and says that “further prioritization and specific vaccine recommendations will become possible once product-specific details are known, such as vaccine specificities and characteristics, its efficiency and benefit assessment for specific groups, as well as storage and supply chain requirements.”
For now it has identified as priorities health care and long-term care workers, people aged over 60, those who are vulnerable because of health conditions, those unable to physically distance (eg prisoners, people in refugee camps and factory workers), and other vulnerable socio-economic groups.
As the availability of vaccines improves, vaccination strategies will need to be adjusted accordingly, for example beginning with a focus on bringing down death rates and disease burden, then shifting to reducing wider societal and economic impacts, the communication observes.
Once vaccine production is scaled up and the amount and pace of vaccine supply starts to meet demands, “it will be important to start assessing population immunity and the possible protection that may be provided because of it.”
In order to speed up the deployment of vaccines once they are authorized, the commission has discussed labeling and packaging flexibilities with the member states and the EMA “which may be used where possible and for a temporary period.” These flexibilities, which were also mentioned in the June strategy, could help to increase production capacity, reduce transport costs and improve vaccine distribution. They include multi-dose presentations for COVI-19 vaccines, limiting pack and label information to one EU official language, and separate distribution of pack leaflets with each dose.
The communication also highlights the need to tackle vaccine distrust, which it says has already led to insufficient take-up of key childhood vaccines. “Misinformation and disinformation around a possible COVID-19 vaccine has not slowed down and will likely make the eventual deployment and uptake of vaccines more difficult,” it says.
It calls on member state to “start providing citizens with objective, accurate, factual and targeted information about the importance of COVID-19 vaccines. It must be explained that such vaccines are likely to be our only real exit from the ongoing pandemic and that, due to the strict EU market authorization procedure, no corners will be cut in terms of safety or effectiveness.”
So as to bolster the EU’s overall ability to handle a pandemic situation, the commission “intends to shortly be putting forward legislative proposals – allowing concrete and tangible actions – to ensure the functioning of the internal market as well as to bolster the health security framework, the European Centre for Disease Prevention and Control and the European Medicines Agency.”
The commission is also working on a proposal to create an EU version of the US BARDA, as announced by commission president Ursula von der Leyen at her state of the union speech in September. The BARDA, which is part of the HHS Office of the Assistant Secretary for Preparedness and Response, was established to help protect the country against chemical, biological, radiological and nuclear threats, as well as from pandemic influenza and emerging infectious diseases.
An EU BARDA “should be an important step towards reaching a higher level of open strategic autonomy for the development and deployment of pharmaceutical products and health threat countermeasures more generally,” the commission says.
By Ian Schofield