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Source: United Kingdom – Executive Government & Departments

It has been announced this morning that the UK government has accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve the Oxford-AstraZeneca COVID-19 vaccine for use.

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“This is the very good news for the world that we have been expecting.  Authorisation of this vaccine, with usual cold-chain requirements, will mean that a global approach to the global pandemic becomes easier.  There is little doubt that this vaccine has more than enough efficacy to allow for it to be authorised based on the randomised trial data that have been published.  Further follow-up data both on efficacy and the absence of serious harms (safety) will have been made available to the regulatory authority and we can be assured that all data will have been scrutinised.

“The separate decision by the UK body responsible for setting policy in its use, the Joint Committee on Vaccination and Immunisation (JCVI), to allow both the currently UK authorised vaccines to be given with a greater delay between doses to maximise the numbers getting one dose as rapidly as possible is a sensible one.  It cannot have been an easy decision, since the evidence on the efficacy of one dose was more limited, but the crisis in the UK requires more than the usual regulatory approach.

“This will not bring a rapid return to life as it was before Covid-19, but is a very major step on the way.  Recipients of the vaccine will still have to follow distancing, hand-washing and other non-medical interventions to protect themselves and those around them.  No vaccine is 100% effective and behaving as if it were, will serve to prolong the pandemic.

“The availability of large numbers of doses both in the UK and, via various funding mechanisms, for lower-income countries is of enormous importance.

“We can look forward to other vaccines accruing data that will extend the options available globally, and we should hope that the necessary trials, perhaps involving different designs, will be able to be completed.”

Prof Robert Read, Head of Clinical and Experimental Sciences within Medicine at the University of Southampton, and Director of the NIHR Southampton Biomedical Research Centre, said:

“This is a tremendous day for all of us.  With the approval of the AZ vaccine it means that we can vaccinate at scale with the priority for the first phase being those who are vulnerable to severe disease and hospitalisation.  The impact will take a few weeks to be seen but I am certain it will be significant.

“MHRA approval means that a team of qualified scientists have scrutinised the clinical trial and safety data and concluded that the vaccine is safe for deployment and has the efficacy claimed by the manufacturer.  MHRA gave approval for a 2 dose course.

“JCVI has advised the government that the vaccines can be deployed in a way that reaches as many people as possible as quickly as possible, with the emphasis on getting the first dose into vulnerable groups at speed.  JCVI has advised that whilst we should be prepared to give people the second dose, it is acceptable to give that within 12 weeks of the first dose.  This allows some much needed flexibility in a programme as big as this.”

Prof Paul Hunter, Professor in Medicine, The Norwich School of Medicine, University of East Anglia, said:

“In my view the evidence for delaying the second dose of vaccine to enable as many as people as possible to receive the first dose sooner this is clear.  The evidence for this clear from the published report of the Phase 3 trial of the Pfizer vaccine the rate of new cases occurring dropped markedly in the vaccine group compared to the control from 12 days after the first dose (Figure 3, though the quoted efficacy “After dose 1 to before dose 2” includes cases from the first 12 days when there was no apparent effect so under-estimates efficacy after 12 days post first dose)1.

“The evidence for the beneficial effect of a single dose for the Oxford vaccine is somewhat less clear at least from publicly available data.  Graphs of cumulative incidence of primary symptomatic COVID-19 contained in the appendix only start 14 days after the second dose.  So I cannot find data that could allow efficacy calculations before the second dose an graphs in the appendix2.  Nevertheless, what data there is does support extending the time to second dose.  For hospitalisation (a pretty reliable indicator for severe disease) there does appear to be benefit from a single dose (Table 5)2.  In the placebo group there were 6 hospitalisations in the control group and 2 in the vaccine group between 1 and 21 days after the first injection.  However, of the two hospitalisations in the vaccine group both were before day 12, though we do not know how many of the 6 control hospitalisations were also before day 12 so we cannot estimate the post day 12 efficacy for hospitalisations and with such small numbers any confidence intervals are likely to be wide.  But it is clear from table 3 that the ultimate protection of immunisation is not reduced if the second injection is postponed beyond 8 weeks.

“There is also evidence from animal experiments.  For example, Wu et al recently showed with another adenoviral vector vaccine (not the Oxford AstraZeneca one) that a single dose in ferrets did provide protection up to at least 8 weeks when the experiment was completed3.

“So I welcome the news that second doses will be delayed to enable more people to have their first dose sooner and with the rapidly spreading new variant, I have no doubt this decision will save many lives.  But everyone will still need a second dose eventually to ensure that the protective effects of these vaccines lasts.”

1. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine. 2020 Dec 10.

2. Voysey, M., Clemens, S.A.C., Madhi, S.A., Weckx, L.Y., Folegatti, P.M., Aley, P.K., Angus, B., Baillie, V.L., Barnabas, S.L., Bhorat, Q.E. and Bibi, S., 2020. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet.

3. Wu S, Zhong G, Zhang J, Shuai L, Zhang Z, Wen Z, Wang B, Zhao Z, Song X, Chen Y, Liu R. A single dose of an adenovirus-vectored vaccine provides protection against SARS-CoV-2 challenge. Nature communications. 2020 Aug 14;11(1):1-7.

Prof Ian Jones, Professor of Virology, University of Reading, said:

“More glad tidings!  Anyone and everyone will be happy to know that the independent MHRA has found the updated data package provided in support of the Oxford-AstraZeneca vaccine sufficient to warrant approval.  A level of immunity sufficient to prevent severe disease can be generated after only one inoculation of this vaccine so the revised JCVI advice to prioritise giving those at risk their first dose is a sensible idea.  It will allow more people in this group to treated with initial supplies, reduce the threat of hospitalisation from Covid-19, and accelerate the return to normality.”

Prof Trudie Lang, Director, The Global Health Network, Nuffield Department of Medicine, University of Oxford, said:

“The approval of the University of Oxford / AstraZeneca vaccine is tremendous step forward in the collective global effort to get every nation beyond the devastating health and economic impact of COVID-19.

“Global equity in access to a safe and effective vaccine is a collective responsibility and many countries have signed up to achieving this through the COVAX initiative.  We now hope that approval of this vaccine in the UK is rapidly followed by regulatory authorities across the globe so that enacting these pledges now becomes reality.  This is more feasible because this vaccine can be stored and transported at normal refrigeration temperatures and is being manufactured in many sites across the world.

“Approval of another COVID-19 vaccine is a remarkable and incredible scientific achievement in such a short time.  This vaccine offers the real possibility of a route out of the catastrophic impact that this pandemic is having within the most vulnerable communities across the world, if collaboration and a global shared effort can ensure fair supply and uptake.”

Prof Chris Whitty, Chief Medical Office for England and co-lead of the National Institute for Health Research, said:

“It is very good news that the independent regulator has now authorised for use the Oxford/AstraZeneca vaccine.  There has been a considerable collective effort that has brought us to this point.  The dedication and hard work of scientists, regulators and those who funded the research, such as the National Institute for Health Research (NIHR), United Kingdom Research and Innovation (UKRI) and United Kingdom Vaccine Network (UKVN), and the willingness and selflessness of so many volunteers who took part in the vaccine trials were essential in delivering this safe and effective vaccine.  They deserve our recognition and thanks.”

Prof Daniel Altmann, Professor of Immunology, Imperial College London, said:

“This is the fruition of decades of ground-breaking vaccinology and hard graft by the team at the Jenner in Oxford.  It couldn’t be more timely and desperately needed.  At a time when we see the pandemic accelerating beyond our control, a rapid, efficient vaccination programme with good population coverage is our only way out.  This vaccine induces good levels of neutralising antibodies and T cells.  With two vaccines now in the roll-out and  very substantially more doses, it starts to look realistic that this could be achievable by the Spring or early Summer.”

Prof Lawrence Young, Professor of Molecular Oncology, Warwick Medical School, said:

“Approval of the Oxford-AstraZeneca COVID-19 vaccine provides a ray of hope at the end of a very challenging year.

“It also comes at a time when we have just recorded the largest daily increase in the number of infections in the UK and when the NHS is struggling with the number of hospitalisations.  And all this on the backdrop of a more infectious variant of the virus.

“So this approval by the MHRA for emergency use of the vaccine is great news and couldn’t come at a better time.  We await the latest advice from the Joint Committee on Vaccination and Immunisation (JCVI) on the priority for vaccination.  To maximise the number of at-risk groups receiving the vaccine, the first dose will be given to as many people as possible with the second dose being delayed for up to 12 weeks.  This will allow the 100 million vaccine doses ordered by the UK government to be rolled out to as many people as possible starting as soon as next week.”

Prof Ravindra Gupta, Professor of Clinical Microbiology, University of Cambridge, said:

“The news of emergency use authorisation for the Oxford vaccine could not have been more timely given the acceleration in transmission and the new variant of concern bearing multiple mutations.  The plan to give as many first doses as possible is sensible but NHS staff need to be prioritised because sickness in NHS staff will ultimately cost lives during this winter crisis.  We must also target vaccination to control transmission and bolster social restriction measures.  The efficacy of the vaccine should also be thoroughly tested by prospective study, in particular the protection offered against both the B1.1.7 variant and other circulating viruses.”

Prof Dame Ottoline Leyser, Chief Executive, UK Research and Innovation, which helped to fund the vaccine, said:

“MHRA approval for the Oxford vaccine is such good news on which to end the year.  This is a safe and affordable vaccine that is easily distributed at fridge temperature.  It has a key role to play in saving lives worldwide.

“This is the culmination of a year of dedicated hard work, but the work will continue to understand better the immunity the vaccine confers, the most effective dosage regimes, and to continue to track its safety, duration of effectiveness and impact on transmission.”

Prof Fiona Watt, Executive Chair of the Medical Research Council, which helped to fund the vaccine, said:

“By moving swiftly to approve the vaccine, the MHRA have ensured that a safe and effective route to halting the pandemic is available to the UK population.”

https://www.gov.uk/government/news/oxford-universityastrazeneca-vaccine-authorised-by-uk-medicines-regulator

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Stephen Evans: “No conflicts of interest.  I am funded (one day per week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them.  I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI.  I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.  I am a participant in the Oxford/Astra Zeneca trial, but am still “blind” to the vaccine received.”

Prof Robert Read: “I am a member of JCVI.  I have no conflicts.”

Prof Ian Jones: “No conflicts.”

Prof Trudie Lang: “I work at the University of Oxford, but in a different group to the Oxford Vaccine team.”

Prof Daniel Altmann: “None.”

Prof Lawrence Young: “No conflicts of interest.”

Prof Ravindra Gupta: “No disclosures.”

None others received.

MIL OSI United Kingdom