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 Pfizer-BioNTech COVID-19 vaccine for use.
This Roundup accompanied an SMC Briefing.
Prof Clive Page, President-Elect of the British Pharmacological Society (BPS), said:
“News of regulatory approval for a COVID-19 vaccine is a real moment of hope for a way through the pandemic.
“It is a testament to the UK’s long-standing leadership in medicines regulation and safety that the UK was able to prioritise this assessment and progress it so quickly. It’s important to note that in this case, speed was the result of focused and sustained effort in research, development and regulation – no safety shortcuts were taken. As is standard with any new therapeutic, the regulators will continue to monitor the vaccine as it is rolled out in the coming days, weeks and months.
“A great number of people and organisations have been involved in getting us to this stage, not least those who took part in trials and enabled this research to happen. Vaccines save millions of lives across the world every year– they are critical for public health. There are still challenges ahead, but vaccinating populations on a global scale is the way we can prevent the loss of life, and way of life, that has been caused by this virus. This news takes us a step closer.”
Sir Patrick Vallance, the Government Chief Scientific Adviser, said:
“It is very good news that the MHRA has approved for use the Pfizer-BioNTech vaccine. This is a significant step towards tackling Covid-19 and an incredible achievement by all involved.
“It will take some time before vaccination is widespread and for now, we must be very careful to stick with our current measures to keep the virus at bay.”
Prof Fiona Watt, Executive Chair, UK Medical Research Council (MRC), said:
“This is great news – the MHRA is to be congratulated on moving so swiftly to approve the vaccine for public benefit”
Prof Derek Hill, Professor of medical imaging science, UCL, and expert in medical devices, said:
“The MHRA has been extremely agile and responsive throughout the covid pandemic. Rapid decision in the Pfizer vaccine is the latest example.
“All the political statements about this being some triumph of the UK in coming “first in some race” is, however, unwise.
“We must assume that the MHRA acted efficiently and diligently and free from any political interference, despite the tone of political announcements this morning. We will no doubt soon hear decisions from FDA and EMA on this vaccine.
“It is important to remember that the role of a regulator is not just to review data and decide whether a medicine can be made available, but also to review the clinical trial plan (called a protocol) and ensure rigorous execution of that plan, and also to ensure safe use when it is marketed. In this case we understand the key Pfizer data was collected in the US under FDA oversight. The FDA therefore also had critical role in getting this vaccine developed so fast.
“It is important to celebrate a very international endeavour.
“Also, it is important to realize that the MHRA operated in the framework of the EU medicines regulations, using a permitted derogation allowing national decisions in times of public health emergency. It seems other EU countries have chosen to work with the EMA (also operating under a derogation to speed up the process). But since MHRA is no longer involved in EMA decisions UK has chosen to use the national derogation.
“From 2021, the MHRA will have to chose how to operate outside of European medicines regulations. The impressive achievements of the MHRA during covid are evidence it has strong capabilities as an independent regulator.”
Dr Richard Torbett, Chief Executive, The Association of the British Pharmaceutical Industry (ABPI) said:
“Today’s approval for the Pfizer / BioNtech vaccine in the UK is great news and another milestone in the fight against COVID-19.
“That people in the UK will be among the first to be offered a vaccine is a testament to the timely and dedicated work of our world-class health regulator, the MHRA.
“With a number of new vaccines on the horizon, it’s exciting to see that the scientific partnerships forged earlier in the year may finally be starting to lead us out of this pandemic.”
Prof Adam Finn, Professor of Paediatrics, University of Bristol, said:
“The licensure of the Pfizer-BioNTech mRNA COVID-19 vaccine is an important national and global landmark in our efforts to control the COVID-19 pandemic. The initial deployment aims at direct protection of individuals at highest risk of exposure or of severe illness if infected and this translates into targeting elderly people since age is the pre-eminent risk factor for hospitalisation and death and front-line health and social care workers who are frequently exposed to the virus and whose continued health and ability to work is an absolute requirement for the resilience of the NHS and the provision of care. Detailed advice from JCVI was published this morning and can be found at:
“As experience of use of these vaccines grows and more results from ongoing studies come in, the strategy for their use will certainly develop and change. Assuming other vaccines are approved and supplies increase, it is likely that immunisation will be offered to more people. How long this will take is hard to predict accurately at present.
“There is a pressing need to provide good quality information for the public about this vaccine and the immunisation programme more generally as it gathers momentum. There are clearly enormous operational and communication challenges ahead and all of us involved in the research to develop these vaccines, in the authorisation process, in policy development and in deployment are determined to provide people with the information they need and to provide answers to any questions or concerns that come up and we will work with the media to achieve this.”
Dr Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said:
“The news that the Pfizer/BioNtech vaccine has received MHRA approval is welcome indeed. It reflects amazing progress in advancing a vaccine through to use in humans and surely sets a new standard for what can be achieved when sufficient resource and scientific focus is applied to global health. Importantly, whilst the administrative side of regulation has been accelerated, no corners whatsoever have been cut in terms of assessing the safety of this, or the other vaccines in the pipeline. It is critical that a clear message is sent to quash the unhelpful and unfounded rumour mill that has already started churning out misinformation.
“Perhaps the most profound impact that this and other vaccines might have, at least in the short to intermediate term, will be for those classed as extremely clinically vulnerable to severe COVID-19. Whilst we have all had limitations imposed upon our lives and livelihoods since March, shielders have lived with a very real and imminent threat from SARS-CoV2 infection. This has led many to either cut themselves off from much of normality, or, more worryingly, many of those least well off have been forced to expose themselves to such risks as a result of having to continue to work. It is also important that the government, regulators, and agencies involved in distributing the vaccine remember that shielders are not merely confined to the elderly, and that all of the millions of people currently living with these risks are prioritised to receive it.
“Whilst the vaccine is now coming to the rescue, we must not forget that shielders have again been placed at unnecessary risk as a result of the resurgence of infections occurring since September. This altogether avoidable scenario has also led to another unwanted lockdown, increased restrictions, and socio-economic damage on an unprecedented scale. This loss of control occurred primarily as a result of policies that failed to suppress infection which, whilst temporarily held in check by the summer, ultimately led to the many hundreds of deaths we are seeing on a daily basis at present. We have become worryingly desensitised to the horrific numbers reported in these updates and must remember that each of these is a cherished family member, loved one, and friend. As we look to the future deployment of this vaccine as a way back to normality, we must not forget the human cost of this pandemic, and ensure that the lessons learned around acting swiftly and decisively to follow guidance are enshrined in a new level of preparedness and investment in our public health systems.”
Dr Mary Ramsay, Head of Immunisations at PHE, said:
“The recommendations from the JCVI and MHRA provide confidence that the Pfizer/BioNTech vaccine has met the very high standards needed to roll out the vaccine. This is a big step forward in tackling the virus.
“This means it can be delivered to those most at-risk, to help prevent as many deaths from COVID-19 as possible. Once deployed, PHE will work alongside the MHRA to keep the safety and efficacy of the vaccine under constant review.”
Dr Zoltán Kis, Research Associate at the Future Vaccine Manufacturing Hub, Imperial College London, said:
“This is excellent news and a historical moment, both for Covid-19 vaccination and for the mRNA vaccine platform technology.
“This 10-month vaccine development, clinical testing and regulatory approval process has been made possible in record time due to the following four key reasons:
“This is the first mRNA vaccine ever to be approved and this technology puts us in a much better position to develop other vaccine candidates and vaccines, including vaccines against currently unknown viral pathogens.
“For the current Covid-19 pandemic, there are still substantial manufacturing, distribution and administration challenges ahead, but the MHRA’s approval of the Pfizer/BioNTech vaccine is a huge step for overcoming this pandemic.”
Dr Charlie Weller, Head of Vaccines at Wellcome, said:
“This is a historic day and an important moment at the end of an incredibly difficult year. For a vaccine to be developed, receive emergency approval and be ready to roll out in less than a year for a new virus is completely unprecedented. The speed of development for this and other vaccine candidates is testament to an extraordinary, collaborative, global research effort.
“This emergency use authorisation from the MHRA is a significant milestone and is very encouraging. This decision, independent from government or other external influence, begins to clear the path for this vaccine to be rolled out to a wider population. There are now important considerations and significant logistical hurdles ahead. We have never attempted to roll out any vaccine at this sort of scale and at this sort of speed anywhere in the world.
“As normal for any vaccine, there will be a need for close and continued monitoring for safety and efficacy as it is delivered. We will also need to continue tracking and improving our understanding on how long the protection lasts. We must recognise that not everyone will have a vaccine immediately or even early next year. It is critical that groups most at risk, such as the elderly and frontline healthcare workers, are prioritised to receive the first doses.
“This is a huge step forward in the effort to end this pandemic. It is remarkable to be at a stage where we have multiple vaccines on the horizon. But we must not be complacent. If we are to have enough doses for the entire world, we will need a range of vaccines that work across different groups and settings. It is therefore vital there is continued global investment in developing a wide range of candidates. Alongside vaccines, we will need effective treatments, tests and most of all global collaboration, to overcome Covid-19. Today, we are a step closer.”
Professor Wei Shen Lim, COVID-19 Chair for JCVI, said:
“The JCVI has considered the safety and efficacy data on the Pfizer/BioNTech vaccine and we’re pleased to say that it supports vaccinating those most at-risk of death from COVID-19 – starting with older people in care homes and those aged 80 years and above.
“This priority reflects the available data on those most at-risk of serious disease and death from COVID-19 infection. Our advice will be updated depending on the safety and characteristics of other vaccines, once available.”
Professor Sir Robert Lechler PMedSci, President of the Academy of Medical Sciences said:
“The authorisation of the Pfizer-BioNTech COVID-19 vaccine is brilliant news and a historic moment providing a light at the end of a gloomy tunnel.
“This vaccine is an example of the extraordinary power of biomedical science demonstrating how medical research has played a vital role in helping us understand and respond to this virus. It will take time to achieve mass vaccination so we must not relax our guard against COVID-19 yet, in fact now is the time to strive to stay safe more than ever.
“We are fortunate to have an excellent regulatory system in the UK that has determined the vaccine has met stringent safety and quality standards, as well as confirming its effectiveness – all of the vital and rigorous steps have been taken to make sure this vaccine is safe.
“The Pfizer-BioNTech COVID-19 vaccine does come with challenges such as storage at around -70C which is why I am pleased that there are other promising vaccines that could be approved for use soon, and I look forward to more good news within the comings months.
“To ensure good uptake of COVID-19 vaccines it is essential that public health messages around vaccination reach all parts of society, regardless of age, socio-economic background, ethnicity or language. The best way to do this is work hand in hand with different communities to understand the questions they have, to co-produce effective messages and understand the best ways to share them.
“This vaccine is a fantastic new tool in our defences against the virus, but we all still have a part to play in preventing the spread of COVID-19. I urge everyone to keep sticking to the measures, including the use of face coverings, social distancing, following the guidance on tier restrictions and isolating when sick. It is vital we all stay healthy to enable the NHS to support the roll out of this new vaccine.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
Today is a good news day. However, we do have to acknowledge several key things that are not being said by everyone
1) We will not be able to change distancing, mask wearing etc for quite some time- months at least, and we don’t yet know when or whether that will stop
2) Making vaccination available is not enough; people need to be convinced so that they do accept being vaccinated
3) We do not yet know about effects of vaccines that are extremely rare, and before we do there will be scares about adverse effects that are coincidental in fact, but perceived by some as being caused by the vaccine. As soon as we vaccinate very large numbers of people there will be coincidental deaths and strokes that occur in elderly people soon after receiving a vaccine. The MHRA and other groups are poised to study these things and to ensure that they are not in fact CAUSED by vaccination, but such events we know will happen, but jumping to conclusions will be unwise
4) Although we are, physically, an Island, viruses do not respect borders. “No country is an island entire of itself; every country is a piece of the world, a part of the world” (adapted from John Donne 1624). We need to ensure low and middle income countries must also get access to effective vaccination. Selfishness will rebound.”
Dr Penny Ward, Visiting Professor in Pharmaceutical Medicine at King’s College London and Chair of the Education and Standards Committee of the Faculty of Pharmaceutical Medicine, said:
“The MHRA, EMA and FDA have different procedures which need to be completed before they can take a decision on an application for use of a new drug/vaccine. The FDA rule requires the agency to complete an internal assessment and to consult an external advisory board prior to making a decision, although not strictly required for emergency use authorisation, because of the public health implications of potential very widespread use of a vaccine, they have already stated that this will form part of their actions on receipt of the file. The ad boards will be held on Dec 10th for the Pfizer and Dec 17th for the Moderna vaccines. The EMA has to align independent view from 27 separate member states. They do this by consulting the Committee on Human Medicinal Products (CHMP) which has fixed meeting dates set throughout the year. They have been conducting a ‘rolling review’ of the documentation for all three vaccines so they are moving much faster than usual – their usual process to the first CHMP discussion for a ‘normal’ appraisal takes 180 days (6 months) with a potential further 6 months if there are questions (which there usually are, even for conditional approval applications). The MHRA similarly have been reviewing the documentation and have been permitted to take unilateral decisions as the UK is exiting the EU on Dec 31; this was written into the UK emergency legislation. The MHRA are a very efficient organisation and have been reviewing all the same information as the EU will have received. Unlike the EMA, they can ask questions as they go and obtain responses faster as a single agency. They will also consult their specialist committee, the Committee on Human Medicines and this committee can meet ad hoc as well as at fixed timescales. The UK have also used their early access schema as a means to permit early access to potentially useful medicines for this pandemic and this offers a fast route to initial authorisation. Approval for use is of course only the first step, then the product has to be actually supplied: this may prove to be more challenging but the willingness of the vaccine task force, the support of the operation warp speed and CEPI monies have all supported the massive expansion of manufacturing ‘at risk’ so that large quantities can be supplied as rapidly as possible.”
Dr Andrew Garrett, Executive Vice President, Scientific Operations, ICON Clinical Research, said:
“Decisions around prioritization will need to made within the constraints of the approved product label, so it will be important to see the labelling approved by the MHRA, particularly around age groupings. The regulatory review of data will be rolling and as more data accumulate the labelling is likely to be updated to widen or restrict use. This will include information on adverse events. With more than 10,000 individuals receiving the active vaccine to date in clinical trials, common, uncommon and even rare events (<1 in 1,000 type events) will likely be well characterized and very rare events (<1 in 10,000 type events) would have had a reasonable chance of being observed. The labelling will enable those who are eligible for vaccination to make informed choices and support effective roll-out.”
Professor Arne Akbar, President of the British Society for Immunology, said:
“This is a momentous day for us all. COVID-19 has impacted all our lives in so many ways and hope of an exit strategy has relied on a safe and effective vaccine. Today that hope has been realised with the announcement that the UK Government has accepted the Medicines and Healthcare products Regulatory Agency’s (MHRA) recommendation to approve the Pfizer-BioNTech COVID-19 vaccine for use.
“It is only 12 months since the first case recorded case of COVID-19 and in that time, researchers around the world have worked tirelessly to increase our understanding of this new disease and develop safe and effective vaccines. To achieve this within this timescale is remarkable and the researchers should be applauded. Although development of this vaccine has occurred rapidly, it’s important to emphasise that it will still have gone through all the rigorous safety tests, and validity of the data on effectiveness will have been assessed meticulously by the MHRA. Although the full dataset has yet to be made public, the previously reported efficacy of above 90% gives us great optimism that this vaccine will be an important tool in stopping the spread of COVID-19 within our communities.
“However this announcement is not the end of the story and there is still much work to do. Roll out of the vaccine is going to be a logistical challenge and rely on our dedicated healthcare professionals around the country. Additionally, building public confidence in the vaccine is going to be crucial in ensuring the high uptake needed to stop the spread of SARS-CoV-2 within our communities. It is essential that we have high profile and multifaceted engagement campaigns that listen and respond to the public’s questions around the vaccine.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“The MHRA has had the early data from Pfizer/BioNTech for quite some time. They have been assessing these data under the legislation that went to Parliament in October and came into force in November.
“The final data went to the MHRA about two weeks ago.
“Their internal experts on the various aspects around the vaccine’s safety, quality and effectiveness will have written a report to go to the independent experts on vaccines and then to the Commission for Human Medicines. The experts and the Commissioners are academic experts in various fields. They will have gone through the assessment report and then discussed it in detail. This will have been done in a Zoom-type meeting, and may have also allowed them to question the company’s internal experts. They will have then voted on whether they should advise that an authorisation should be given.
“This advice is then passed to Ministers in the Government via the MHRA.
“The three aspects they must be satisfied on are:
1) Quality – they will have inspected manufacturing to ensure that the vaccine delivered is up to standard
2) Safety – there are no harms beyond what is seen for most vaccines that occur at a rate that would make the vaccine unsafe to be given to large numbers. Some possible harms that occur very rarely indeed may only be seen when a vaccine is in use
3) Efficacy- that the vaccine prevents the occurrence of Covid-19. The data will be strong on prevention of mild disease but will also show evidence of protection against severer disease which is much rarer
“When Ministers grant the authorisation, then the Joint Committee on Vaccination and Immunisation, who have already advised on priority groups, will advise on the strategy for roll-out
“The company are said to be able to provide 800,00 doses very rapidly. Whether these does will be used for 400,000 or 800,000 of the highest priority group will depend on whether they could provide another 800,000 doses within three weeks”
Dr John Tregoning, Reader in Respiratory Infections, Imperial College London, said:
“This is great news and remarkable progress given the first cases were less than a year ago. It shows what progress can be made through science and innovation. The MHRA, the UK drug regulator, will have gone through all the safety data from the trials before approving and will continue to monitor as it is rolled out more widely. The next step will be to get the vaccine to the people who need it the most.”
Prof Liam Smeeth, Professor of Clinical Epidemiology, and Dean of the Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, said:
“The continued progress on vaccines is fantastic news. A route towards a much better situation in the UK is becoming clear. A further circuit breaker in January or possibly February is likely to be needed. But, it is realistic to hope that by March or April the vast majority of older people, care home residents, and those with severe conditions will have been immunised. We can then work towards wider immunisation – with ideally much of the population covered in time for next winter. Life won’t ever be the same as it was before Covid-19, but it will feel a whole lot better than now.
“For the foreseeable future – and maybe forever – we are very unlikely to reach the situation we are in with smallpox (gone), polio (almost gone), or measles (controlled in populations with high enough vaccine coverage). Instead, we are going to need to find ways to fairly happily live alongside this virus.
“Maintaining public confidence in the vaccine will be key. Complete, timely data on who has been vaccinated, where, and when will be of enormous importance as we continue to monitor not just coverage, but also safety and effectiveness. Ensuring this data is entered into peoples’ NHS general practice records is crucial. General practice has proven ability to rapidly vaccinate large sections of the population, and with adequate support, is ideally placed to lead the Covid-19 vaccination programme.
“Ensuring equitable global distribution remains a major challenge. And equity is the key. Many low-income countries with little resilience in their health systems and wider infrastructures face unimaginable challenges from Covid-19, and distribution of vaccines according to need will require affirmative action from richer countries, working with the World Health Organisation and other key players.”
Dr Michael Head, Senior Research Fellow in Global Health, University of Southampton, said:
“This is excellent news and a huge landmark in the global efforts to address this pandemic. The regulators have clearly been satisfied with the data presented to them.
The Pfizer vaccine does require storage at around -70C, which will pose significant logistical challenges for all countries that choose to use it. These are not insurmountable but certainly challenging. Other vaccines, such as the Oxford AstraZeneca candidate, require storage at much lesser temperatures and will be simpler to transport. Given we will certainly need more than one licensed vaccine to maximise global coverage, everyone will still be eagerly waiting for further developments from Oxford and Moderna.
“But, for now, this is wonderful news to wake up to.”
All our previous output on this subject can be seen at this weblink:
Dr Stephen Griffin: “No conflicts.”
Dr Penny Ward: “No COIs. I am semi-retired, but I am owner/Director of PWG Consulting (Biopharma) Ltd a consulting firm advising companies on drug and device development. Until July 2019 I was Chief Medical Officer of Virion Biotherapeutics, which was a company developing broad spectrum RNA therapy for the treatment/prevention of respiratory virus infections. Between December 2016 and July 2019 I served as Chief Medical Officer of Virion Biotherapeutics Ltd, a company developing antiviral treatments for respiratory viral diseases. Previous employee of Roche, makers of tocilizumab (anti IL6 antibody) and CMO of Novimmune, makers of empalumab (anti IFN gamma antibody).”
Dr Andrew Garrett: “I am employed by ICON which is a Contract Research Organisation. ICON provides pharmaceutical services to the pharmaceutical and biotechnology industries. ICON conducts clinical trials on behalf of Sponsors, including vaccine trials.”
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.”
Prof Liam Smeeth: “Liam Smeeth is a non-executive director of the MHRA. Comments relating to vaccines are made in a personal capacity.”
None others received.