I hear a Covid-19 vaccine is coming. How soon?
The UK's drugs regulator yesterday approved Pfizer/BioNTech's treatment for the virus, and promised the first doses would be delivered in the coming days. Northern Ireland says it will vaccinate 12,000 people before Christmas.
In the Republic, it is unlikely a vaccine will be available before January.
Hospital Report
Why are things taking longer here?
The European Medicines Agency (EMA) has been operating rolling reviews of various late stage vaccine candidates as part of an effort to fast-track approval for effective vaccines.
While the EMA authorises treatments, member states can use an emergency procedure that allows them to distribute a vaccine for temporary use where there is urgent public need.
Britain has invoked this procedure and gone its own way in terms of authorisation; Ireland will wait for the EMA’s assessment before making a decision.
So Brexit is having an effect?
Britain’s health minister, Matt Hancock, claimed yesterday that “because of Brexit” the UK was able to base its decision on its own regulator and “not go at the pace of the Europeans”. In fact, the UK is still subject to EU rules until it fully leaves at the end of this year, but was able to invoke the emergency authorisation option.
But why is the EMA taking longer?
Britain's Medicines and Healthcare Regulatory Agency, which began its rolling review of the Pfizer vaccine three weeks after the EMA, made its decision on less data. That made the process quicker.
Does that raise safety concerns?
Too soon to say, but the EMA, and some MEPs, have criticised the UK approach. A vaccine for Covid-19 is already on track to be developed at record speed. It normally takes regulatory bodies at least seven months before authorising a treatment.
So when will the EMA make a decision?
Pfizer (and Moderna, with another vaccine it has developed) only formally applied for approval in Europe (and the US) earlier this week. The EMA has said it will decide on that "conditional marketing approval" by December 29th for Pfizer, and by January 12th for Moderna.
How will distribution be carried out?
A plan developed by the Government’s taskforce on vaccine rollout, due to be published next Friday, will set out how many doses are to be distributed, how and where, and who will get them first. There are a lot of variables at play because the different vaccines likely to get the nod have different storage requirements. Some require ultra-cold storage, while others can be kept in a fridge. It is likely jabs will be administered in hospitals, special centres and, for some vaccines, by GPs and pharmacies.
Can anything go wrong?
Lots of things. Up to now, all we know about the results of trials comes from company press releases. Little safety data is available. We don’t know how well the vaccines work on older people, for instance. We don’t know whether they prevent transmission or just protect against illness. We don’t know for how long they will remain effective.
The EMA’s deliberations should shed light on many of these issues, but given the speed with which the vaccines have been developed, some questions will remain. Vaccines can cause very rare reactions, which may only be evident when large numbers have received a jab.
Based on what we know, the most likely contenders are highly effective, have no safety issues and can make a major contribution to reducing the threat posed by Covid-19.
So can we go back to normal soon?
Not quite. It takes a month after the first of two doses before Pfizer’s jab is effective. The process of rolling out the vaccine to most of the population will take much of 2021 – so no-one should be dropping their guard any time soon.
