President Macron reportedly said earlier today of the Oxford/AstraZeneca vaccine “We’re waiting for the EMA results, but today everything points to thinking it is quasi-ineffective on people older than 65, some say those 60 years or older”.
Dr Andrew Garrett, Executive VP, Scientific Operations, ICON Clinical Research, said:
“The EMA has “recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age” and in the Summary of Product Characteristics it clearly states “… in individuals 18 years of age and older” and that “The use of this vaccine should be in accordance with official recommendations”. It also states “Currently available clinical trial data do not allow an estimate of vaccine efficacy in subjects over 55 years of age”, which reflects the judgement of the EMA based on the data available to date. However it is important to be very clear that not having enough data, in no way equates to something being ineffective. Immunological data are available and these will have fed into the overall EMA recommendation. As more data become available, the SPC will likely be updated. However it will become increasingly difficult to obtain placebo-controlled efficacy data in the most vulnerable groups for vaccines (including new candidates), as those groups become eligible for vaccination.
“The decision on within country vaccine prioritisation of their population is however a public health decision and each member state is free to determine their own priorities given their allocations, as has been observed with the approved mRNA vaccine. As reported in Nature in January 2021 (Lazarus et al), France in one of the more skeptical countries internationally when their population is asked if they will take a COVID-19 Vaccine that is proven safe and effective (59%, positive response), so it would not necessarily be a surprise if the roll-out in France, and indeed other countries, accounted for cultural and other differences.”
Dr Peter English, Consultant in Communicable Disease Control, Former Editor of Vaccines in Practice Magazine, Immediate past Chair of the BMA Public Health Medicine Committee, said:
“It is sad to see people misunderstanding the situation here.
“They are confusing an absence of evidence, with evidence of absence.
“For very understandable reasons, it has taken more time to accumulate evidence of efficacy in older people. The trials did not originally include older people (because they wanted to be sure the vaccine was safe in younger people first). And older people mix with other people less, so it took longer to accumulate sufficient older trial participants who became ill or infected with the virus.
“For these reasons, the number of older people who could be included in the trials – at the time of publication – was relatively small; so the direct evidence of efficacy is limited.
“However, such direct evidence as there is, and indirect evidence (such as antibody and T-cell responses) clearly suggest that the vaccine will be effective in older age groups.”
All our previous output on this subject can be seen at this weblink:
Dr Andrew Garrett: “I am employed by ICON which is a Contract Research Organization. ICON provides pharmaceutical services to the pharmaceutical and biotechnology industries. ICON conducts clinical trials on behalf of Sponsors, including vaccine trials. I am a member of the UK Statistical Authority’s (UKSA) Research Accreditation Panel.”
Dr Peter English: “No DOIs.”