‘Reverse Covid vaccine second dose delay plan’
MINISTERS PUTTING POLITICAL GAIN AHEAD OF SCIENCE, SAYS ACADEMIC
THE start of 2021 has hardly been what the public expected, because it seems obvious that the virus has come back at us with a vengeance.
However, there is hope in the form of three vaccines, and more will arrive this year.
Thanks to the commitment of the NHS family, more than five million people have received their first dose of the vaccine in an effort to meet the government’s target to vaccinate the first four priority groups – residents in a care home for older adults and their carers; all those 80 years of age and over and frontline health and social care workers; all those 75 years of age and over and all those 70 years of age and over and clinically extremely vulnerable individuals (Priority groups for coronavirus (Covid-19) vaccination: advice from the JCVI, December 30, 2020: gov.uk (www.gov.uk) by mid-February – equating to 13.9 million people.
We surely have an early success of a crucial national campaign to defeat the dreaded virus, but concern is growing that the government’s two-dose strategy has a serious flaw. The government’s advice to delay the second dose to 12 weeks is not based on data from the Pfizer/BioNTech trial, but on an assumption of what would have happened if the second dose hadn’t been given at 21 days.
While assumptions can be useful for political advantage or generating a hypothesis, they are not a sufficient reason to alter a known effective dosing regimen. And so, while the hypothesis could potentially be an accidental fact, it is far from clear what this is based on and what data was available to the government’s scientific advisers to alter the results of random controlled trials, which is the gold standard for evidential support recommended by the Medicines and Healthcare products Regulatory Agency (MHRA) in what is a rigorous process of approval of any drug in use for patients.
The World Health Organisation (WHO) has categorically stated that ‘people should get two doses of the Pfizer and BioNTech vaccine within 21-28 days.’ There have also been suggestions from Israel that the protection from a first dose could be far less than originally thought.
Science tells us that vaccines proven to be effective in a particular dosing schedule are not altered without solid scientific support or evidence. The vaccine used in the Oxford/AstraZeneca study is a different type of vaccine (viral vector DNA), for which there are prior data from other similar vaccines, and it does make sense to increase the interval to 12 weeks. But that’s not true for Pfizer/BioNTech vaccine, which is a different type of vaccine altogether (mRNA).
The Joint Committee on Vaccinations and Immunisation advice (JCVI) – and the endorsement of all four nations’ chief medical officers to delay the second dose to between four and 12 weeks – is not based on data from trials, but on the political desire to immunise as many as possible in the first wave of the programme. I do not agree this is a sufficient reason to alter a known effective dosing regimen.
Independent scientists have genuine concerns that extending a second injection out to beyond 28 days could compromise vaccine efficacy. Increased coverage with the first dose as predicted by politicians could come at increased risk to already highrisk/priority groups. Staff illness rates are significantly higher than usual, and confidence within the profession is certainly badly shaken by disregard of the manufacturer’s and WHO’s recommendations to give the second dose within 21 to 28 days.
BAME communities are genuinely concerned about receiving the vaccine. A recent poll by the Royal Society for Public Health, conducted at a national level, found only 57 per cent of BAME people would accept the vaccination, in comparison to 79 per cent of white people in the UK. So, delaying the second dose to 12 weeks would further damage confidence in the vaccination programme.
Not allowing the second Pfizer dose within the recommended timeframe by the manufacturer is nothing less than politicians taking over science. Pfizer/Biotech and WHO have explicitly said that there is no data to suggest that the first dose is effective beyond three weeks.
This is incredibly distressing for older people, health workers and BAME communities, who thought they were going to be protected.
Surely the researchers and scientists who designed and manufactured the vaccine are the ones we should be listening to, rather than politicians. The ambitious vaccine rollout could suffer a severe setback if the chief medical officers ignore the scientific facts and evidence to reverse the decision of delaying the vaccine to 12 weeks.
There is longer-term damage – the medical community is already concerned that science has become a casualty of political interference. Those in positions of authority must surely recognise this and cease to use science as a political football.
Prof Kailash Chand is also a former deputy chair of the BMA council and chair of NHS trust.