In the face of rising cases and deaths, the arrival of multiple vaccines for Covid-19 within 12 months of the new virus being identified almost seems to have been taken for granted given that the identification of a disease agent to a final vaccine usually takes years or even decades. Multiple bets on vaccine candidates were made, some have paid off. Large-scale manufacturing was ready.
Good science and good regulation has saved lives but the launch of the Covid-19 vaccines has not been without controversy regarding how the vaccines will be issued by the Joint Committee on Vaccines and Immunisation (JCVI).
One controversy concerns the delay of the second vaccination with the Pfizer mRNA vaccine and Oxford-AstraZeneca vaccine to maximise uptake in the short-term, while another concerns the Green Book advice on which vaccine to give if it is not known which vaccine the patient has received for the first dose (or where the first vaccine given is not available the second time).
The latter case is a simple misreading of the Green Book. A New York Times story with the headline ‘Britain Opens Door to Mix-and-Match Vaccinations, Worrying Experts’ argued that the UK had quietly updated its vaccination rules to allow for a mix and match regimen of vaccines. US experts chimed in with “We’re kind of in the Wild West” and that the UK “seemed to have abandoned science completely now and are just trying to guess their way out of a mess”.
Chapter 14a of the Green Book covers Covid-19. There is an extensive technical walk-through of the disease, the vaccine schedule, and dosing that any competent UK healthcare professional would be able to follow. At no point does the guidance suggest routinely mixing the vaccines.
The guidance on previous incomplete vaccination does suggest that it is reasonable to offer one dose of the locally available product to complete the schedule if the patient is “at immediate high risk or is considered unlikely to attend”. However, this is only after multiple statements that the same vaccine should be used, with an acknowledgement that there is no evidence at present on the interchangeability of Covid-19 vaccines.
Added to this, on December 30, 2020, Simon Stevens, chief executive of the NHS, wrote to all the areas of the NHS that might be involved in vaccinations stating that, “each person’s second dose must be from the same manufacturer as their first dose”.
Public Health England’s head of immunisations, Dr Mary Ramsey, provided additional clarity on the BBC: “We do not recommend mixing the Covid-19 vaccines – if your first dose is the Pfizer vaccine, you should not be given the AstraZeneca vaccine for your second dose and vice versa.”
The editor of the BMJ has written to the New York Times asking them to correct the report.
The biggest controversy has been the UK’s policy to delay the second dose of the Pfizer and Oxford- AstraZeneca vaccines to maximise a quick roll-out to at-risk groups. Largely people were concerned that the UK was going against the product licence, but there were also theoretical concerns about reduced vaccine efficacy in the longer term.
Given the new more transmissible variant of Covid-19 is spreading, with a huge rise in cases and corresponding pressures on hospitals, the JCVI decision seems like a pragmatic one to reduce hospital admissions and save lives overall.
For example, while the efficacy of the Pfizer- BioNTech vaccine was 52.4 per cent over average between the first and second dose, most of the failures are in the first days after the first dose.
From days 15 to 21 the efficacy against symptomatic Covid-19 appears to be 89 per cent. The company stated that there was no evidence of protection after 21 days, but companies are under different rules than the JCVI, which has to bear in mind all aspects of the situation, not just the licence they were granted.
The JCVI gave a logical overview of its decision, using the best evidence it had. It might not be the right decision but that is something that has to be accepted when any scientific decision is made. Waiting for the evidence to put this matter fully to rest would mean a greater number of vulnerable people being at risk in the short-term, so using the best evidence we have to make pragmatic decisions in a timely manner is a good utilitarian approach.
Evidence-based medicine has never been about mindlessly sticking to randomised controlled trial evidence without context. Sackett et al defined it as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients”.
Changing “individual patient” to “a population” in a public health setting makes logical sense in this case, and the JCVI appears to have been judicious in its use of the evidence in the face of rising deaths in the UK. In the end, it is likely many second doses are given close to the licenced time, and with luck the single dose Johnson & Johnson vaccine will make things even easier.
It is a common view that we are living in an age where criticism of experts is common and linked to populist politics. The JCVI and MHRA make independent non-political judgements and are staffed by world leading experts in their field.
While Trump was willing to give advice on disinfectants, hydroxychloroquine, and “light inside the body” in front of his cringing expert advisers, the UK Government has been very careful to defer to experts on evidence for therapies for Covid-19 in Government briefings.
Of course, there have been missteps. Experts under-estimated the public’s ability to comply with lockdowns, the advice on masks was changed long after it should have been and border controls should have been imposed sooner. However, all too often UK vaccine policy is presented as “the Government”, when it is actually the result of expert committees who have to balance multiple concerns.
While vaccine confidence in the UK is relatively high in comparison to other countries, these sorts of controversies feed directly into confidence-reducing posts on social media and the wider media. Anti-vaccinators tend to focus on vaccine harms, quack science, long standing tropes and a broader anti-establishment view, but individuals trying to make political points by manufacturing concerns about vaccine policy should be cautious.
Without trust in society nothing can work, and while critics of the Government are free to criticise ministers, they should resist the urge to politicise the UK’s expert committees at the MHRA and JCVI.