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• G7 leaders donate 870 million vaccine doses for low and low-middle income countries over the next year, vital for reducing virus transmission.
  
• G7 leaders emphasize the importance of all ACT-Accelerator tools to exit the pandemic.
  
• ACT-Accelerator’s funding gap remains significant with an urgent need for funding of tests, treatments and health systems to ensure an end to the pandemic everywhere.
  
• WHO Director General warns of increasing divide in equity to crucial COVID-19 tools.
  
• Total funding committed to the ACT-Accelerator partnership remains US$ 15.1 billion with a gap of over US$16 billion.

  At the close of this year’s G7 Leaders’ summit, the Prime Minister of the United Kingdom of Great Britain and Northern Ireland announced a donation of an additional 870 million vaccine doses from attendees, with the majority to be delivered through COVAX, the vaccines pillar of the Access to COVID 19 Tools Accelerator, within the next year. Attendees included heads of G7 Member States plus Australia, India, South Africa and Republic of Korea, invited as guests.
  

  Leaders confirmed their support for all pillars of the ACT-Accelerator across treatments, tests and strengthening public health systems as well as vaccines (link to the communique). Additionally, they indicated their intention to work together with the private sector, the G20 and other countries to increase their vaccine contribution over the months to come. Since their G7 Early Leaders’ Summit in February 2021, the G7 has committed one billion doses in total.
  

  Timing is key

  WHO Director General, Dr Tedros Adhanom Ghebreyesus, spoke to leaders at their meeting and urged “many other countries are now facing a surge in cases – and they are facing it without vaccines. We are in the race of our lives, but it’s not a fair race, and most countries have barely left the starting line. We welcome the generous announcements about donations of vaccines and thank leaders. But we need more, and we need them faster”.
  

  Over US$ 16 billion is still needed this year to fully fund the work of ACT-Accelerator, the global partnership of leading international health organizations which is mid-way through its 2020-21 funding need. In additional to vital vaccine research and development and procurement work, ACT-Accelerator needs funds to strengthen health systems and protect health workers administering the tools needed to end the pandemic; tests to detect and contain hotspots, as well as identify new variants that will continue to appear; and treatments to save the lives of those who will continue to catch COVID-19 and suffer. There is an urgent need for treatments like oxygen which is seeing a surge in demand that is 5 times – and in cases such as India, 10 times – greater than the need before the pandemic.
  

  The funding needed for the ACT-Accelerator will address challenges delivering products where they are most needed, help establish testing for 500 million people in low- and middle-income countries by mid-2021 and help secure the necessary supply of oxygen as well as distribute 165 million doses of treatments including dexamethasone which can save lives of people critically ill with COVID.
  

  Carl Bildt, WHO Special Envoy for the ACT Accelerator, said: "We welcome these commitments but there is still a significant funding gap that must be closed if we are to get the urgently needed treatments, including oxygen, and tests, to low and lower-middle income countries so we aren’t flying blind to where the virus is and how it’s changing. The time to act is now. We look to the G7 and G20 to fund the work of the ACT Accelerator, the global multilateral solution that can speed up an end to the pandemic. The world needs their political leadership because left to rage anywhere, the virus will remain a threat everywhere."
  

  “This is an important moment of global solidarity and a critical milestone in the push to ensure those most at risk, everywhere are protected,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance (Gavi). “As we strive towards or goal of ending the acute phase of the pandemic, we look forward to working with countries to ensure these doses pledged are quickly turned into doses delivered.”

  Dr Philippe Duneton, Executive Director of UNITAID, said: "These commitments from G7 leaders are important and welcome. But it is crucial to remember that right now, COVID-19 patients around the world are dying and suffering due to a lack of oxygen, an essential medicine that is vital for the treatment of COVID-19. I would urge G7 leaders to act now to ensure that all pillars of the ACT-Accelerator are fully funded – including those focusing on treatments and tests. As recent events in India, Nepal and elsewhere have shown, we need more than vaccines to end this pandemic everywhere.”

  Henrietta Fore, Executive Director of UNICEF, said: “The impact of the pandemic in its second year is already far worse than its first. We are seeing significant and devastating outbreaks all over the world – including south Asia, southern Africa and Latin America. We must continue to sound the alarm. The longer the virus continues to spread unchecked, the higher the risk of more deadly or contagious variants emerging. The clearest pathway out of this pandemic is a global, equitable distribution of vaccines, diagnostics and therapeutics, and the overall strengthening of health systems across the globe, because no one will be safe until we are all safe.”
  

  Dr Emma Hannay, Chief Access Officer and ACT-Accelerator Lead for FIND, said: “We thank the G7 for their leadership and continuing drive to ensure R&D and equitable access to diagnostic testing, necessary both for the fight against COVID-19 and to lay the foundations that will prepare the world to guard against future pandemics.”
  

  Dr Richard Hatchett, CEO of CEPI, said: “This is an historic moment - as leaders of some of the wealthiest counties come together to ensure that all parts of the world have access to life saving vaccines. This pandemic has shown us that we cannot set national against international interests. With a disease like COVID-19 we have to ensure that we get it under control everywhere.  There is still much to do to get vaccines in arms and ensure our research and development allows us to stay one step ahead of the virus. But for today we give pause and celebrate a watershed moment of political alignment and collaboration”.
  

  Peter Sands, Executive Director of The Global Fund, said: “It is encouraging to see such global collaboration and commitments. However, none of the lifesaving tools to fight COVID-19 will deliver themselves. We need to make sure that health systems are prepared and that front-line health workers are sufficiently protected to deliver these tools without risking their own lives. This can only happen if the ACT-Accelerator is fully funded.”
  
  

  Notes to Editors

  The Access to COVID-19 Tools (ACT) Accelerator is the proven, up-and-running global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by WHO, the European Commission, France and The Bill & Melinda Gates Foundation in April 2020.
  

  The ACT-Accelerator is not a decision-making body or a new organization but works to speed up collaborative efforts among existing organizations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organizations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it. 

  The ACT-Accelerator comprises four pillars: diagnostics, therapeutics, vaccines and health system strengthening. 
  

• The diagnostics pillar, co-convened by the Global Fund and FIND, is focused on ensuring equitable access to new and existing tests, supporting country uptake and deployment and strengthening the diagnostic portfolio with R&D investments in low-cost, easy-to-use and quality tests. In 2021, it is focused on procuring and distributing at least 900 million molecular and antigen rapid tests to low- and middle-income countries.
• The therapeutics pillar is led by Unitaid and Wellcome. Therapeutics can play a role in all stages of COVID-19 disease: to prevent infection; suppress symptoms and spread of infection to others; treat or prevent symptoms; as a life-saving treatment for severe symptoms; and as a treatment that can speed up recovery. The aim in the next 12 months is to develop, manufacture and distribute millions of treatment doses, helping COVID-19 sufferers to recover from the disease.
• The vaccines pillar, convened by CEPI, Gavi and WHO, is speeding up the search for an effective vaccine for all countries. At the same time, it is supporting the building of manufacturing capabilities, and buying supply, ahead of time so that at least 2 billion doses can be fairly distributed to the most high risk and highly exposed populations globally by the end of 2021.
• The health systems connector pillar, led by the World Bank, the Global Fund and WHO, is working to ensure that these tools can reach the people who need them.
• Cross-cutting all of these is the workstream on Access & Allocation, led by WHO.
  

Since April 2020, the ACT-Accelerator has supported the fastest, most coordinated, and successful global effort in history to develop and rollout tools to fight a new disease. With significant advances in research and development by academia, private sector and government initiatives, the ACT-Accelerator has advanced our understanding of what works to fight the disease. It has transformed our ability to tackle COVID-19 on a global scale: vaccines are being rolled-out worldwide, low-cost high-performing antigen rapid diagnostic tests can now detect transmission anywhere, affordable therapies for severe disease can save lives in any setting, and health systems are being strengthened to help roll out these tools.

 

• COVAX welcomes dose sharing commitments for 870 million additional doses to support equitable access to vaccines in 2021 and 2022, with the aim to deliver at least half by the end of 2021.
   
• The G7 has committed one billion doses since the February 2021 virtual G7 Early Leaders’ Summit, including pledges made at the G20 Global Health Summit hosted by Prime Minister Draghi and President von der Leyen and the Gavi COVAX AMC Summit hosted by Prime Minister Yoshihide Suga of Japan. 
  
  
• COVAX partners applaud G7 leaders’ support for global public health.

In a landmark agreement at the G7 summit, held in Cornwall, the United Kingdom of Great Britain and Northern Ireland, global leaders have pledged to share COVID-19 vaccine doses internationally, in support of global equitable access and to help end the acute phase of the pandemic.

Building on the momentum of the G20 Global Health Summit hosted by Prime Minister Draghi and President von der Leyen and the Gavi COVAX AMC Summit hosted by Prime Minister Yoshihide Suga of Japan, G7 countries committed to share at least 870 million doses of COVID-19 vaccines directly, with the aim to deliver at least half by the end of 2021, and reaffirmed their support for COVAX as “the primary route for providing vaccines to the poorest countries.”

COVAX partners welcome this commitment, along with continued support for exporting in significant proportions, promotion of voluntary licensing and not-for-profit global production. COVAX looks forward to seeing doses flowing to countries as soon as possible. Facing an urgent supply gap, COVAX is focused on securing as many shared doses as possible immediately, as the third quarter of this year is when the gap between deliveries and countries’ ability to absorb doses will be greatest. COVAX will work with the G7 and other countries that have stepped up to share doses as rapidly and equitably as possible. This will help address short-term supply constraints currently impacting the global response to COVID-19 and minimize the prospect of future deadly variants. 

In anticipation of the large volumes available through the COVAX Facility deals portfolio later in the year, COVAX also urges multilateral development banks to urgently release funding to help countries prepare their health systems for large-scale rollout of vaccines in the coming months.

“This is an important moment of global solidarity and a critical milestone in the push to ensure those most at risk, everywhere are protected,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance (Gavi). “As we strive towards our goal of ending the acute phase of the pandemic, we look forward to working with countries to ensure these doses pledged are quickly turned into doses delivered.”

“This is an historic moment - as leaders of some of the wealthiest counties come together to ensure that all parts of the world have access to life saving vaccines,” Dr Richard Hatchett, CEO of CEPI (the Coalition for Epidemic Preparedness Innovations), added. “This pandemic has shown us that we cannot set national against international interests. With a disease like COVID-19 we have to ensure that we get it under control everywhere. There is still much to do to get vaccines in arms and ensure our R&D allows us to stay one step ahead of the virus. But for today we give pause and celebrate a watershed moment of political alignment and collaboration.”

Henrietta Fore, Executive Director of UNICEF, said: “We have reached a grim milestone in this pandemic: There are already more dead from COVID-19 in 2021 than in all of last year. Without urgent action, this devastation will continue. Equitable access to COVID-19 vaccines represents the clearest pathway out of this pandemic for all of us — children included. UNICEF thanks G7 member states for their significant pledges and continued support. However, much work remains to continue to ramp up both the amount and the pace of supply to the rest of the world, because when it comes to ending the COVID-19 pandemic, our best interests and our best natures align. This crisis will not be over until it is over for everyone.”

WHO Director General, Dr Tedros Adhanom Ghebreyesus, stressed: "Many other countries are now facing a surge in cases – and they are facing it without vaccines. We are in the race of our lives, but it’s not a fair race, and most countries have barely left the starting line. We welcome the generous announcements about donations of vaccines and thank leaders. But we need more, and we need them faster."

“Africa’s current vaccine supply shortage risks prolonging the pandemic, not just for millions on the continent, but for the whole world,” said Dr Githinji Gitahi, Group CEO, AMREF Health Africa. “I applaud the Group of Seven's leadership in sharing doses with COVAX and urge them - and others to share doses now, not later in the year, when our need is greatest.”

Notes to editors

About COVAX

COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance Gavi) and the World Health Organization (WHO) – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

CEPI’s role in COVAX

CEPI is leading on the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.

Gavi’s role in COVAX

Gavi leads on procurement and delivery at scale for COVAX: designing and managing the COVAX Facility and the Gavi COVAX AMC and working with its traditional Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. As part of this role, Gavi hosts the Office of the COVAX Facility to coordinate the operation and governance of the mechanism as a whole, holds financial and legal relationships with 193 Facility participants, and manages the COVAX Facility deals portfolio: negotiating advance purchase agreements with manufacturers of promising vaccine candidates to secure doses on behalf of all COVAX Facility participants. Gavi also coordinates design, operationalisation and fundraising for the Gavi COVAX AMC, the mechanism that provides access to donor-funded doses of vaccine to 92 lower-income economies. As part of this work, Gavi provides funding and oversight for UNICEF procurement and delivery of vaccines to all AMC participants – operationalising the advance purchase agreements between Gavi and manufacturers – as well as support for partners’ and governments work on readiness and delivery. This includes tailored support to governments, UNICEF, WHO and other partners for cold chain equipment, technical assistance, syringes, vehicles, and other aspects of the vastly complex logistical operation for delivery. Gavi also co-designed, raises funds for and supports the operationalisation of the AMC’s no fault compensation mechanism as well as the COVAX Humanitarian Buffer.

WHO’s role in COVAX

WHO has multiple roles within COVAX: It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL) / prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. WHO leads, together with UNICEF, the Country Readiness and Delivery workstream, which provides support to countries as they prepare to receive and administer vaccines. Along with Gavi and numerous other partners working at the global, regional, and country-level, the CRD workstream provides tools, guidance, monitoring, and on the ground technical assistance for the planning and roll-out of the vaccines. Along with COVAX partners, WHO has developed a no-fault compensation scheme as part of the time-limited indemnification and liability commitments

UNICEF’s role in COVAX

UNICEF is leveraging its experience as the largest single vaccine buyer in the world and working with manufacturers and partners on the procurement of COVID-19 vaccine doses, as well as freight, logistics and storage. UNICEF already procures more than 2 billion doses of vaccines annually for routine immunisation and outbreak response on behalf of nearly 100 countries. In collaboration with the PAHO Revolving Fund, UNICEF is leading efforts to procure and supply doses of COVID-19 vaccines for COVAX. In addition, UNICEF, Gavi and WHO are working with governments around the clock to ensure that countries are ready to receive the vaccines, with appropriate cold chain equipment in place and health workers trained to dispense them. UNICEF is also playing a lead role in efforts to foster trust in vaccines, delivering vaccine confidence communications and tracking and addressing misinformation around the world.

About ACT-Accelerator

The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.

The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.

The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.

Learn what you can do if you have issues with v-safe and how you can reach live v-safe support through phone or email.

Use this step-by-step guide to learn how you can complete a v-safe health check-in for yourself or a dependent.

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Use this step-by-step guide to learn how you can register for v-safe to report any side effects after your COVID-19 vaccination.

Healthcare professionals and public health authorities have a central role in discussing vaccination against COVID-19 with their patients. Vaccines play a critical role in preventing deaths, hospitalisation caused by infectious diseases. Emerging data on effectiveness indicates that licenced COVID-19vaccines are contributing to controlling the spread of the disease. Until widespread vaccination has been achieved, both vaccinated and unvaccinated people need to be aware of the additional protective behaviours required to control the pandemic locally.

The global impact of the COVID-19 pandemic has resulted in an unprecedented level of public interest in vaccines. This includes a focus on the development of vaccines and their regulatory review and safety monitoring. Much of this coverage has taken place through mass and social media.  Reports of adverse events (side effects) have led some people to express concerns about getting vaccinated, delay getting vaccinated or even be strongly opposed to vaccination.  There are also differences in individual confidence in national safety monitoring systems. Another challenge in communicating the importance of COVID-19 vaccination is that younger adults are typically less clinically affected by COVID-19 infection and so may see limited value in getting vaccinated, including until further data confirms that vaccines prevent transmission and that vaccines are effective against variants. Clear and consistent communication is therefore essential to support people in making the choice to be vaccinated.

We appreciate that you, your colleagues and your patients may have a number of questions around the development, regulatory review and ongoing safety monitoring of COVID-19 vaccines.

Purpose

This joint International Coalition of Medicines Regulatory Authorities (ICMRA)* and WHO statement aims to help healthcare professionals answer questions about the role of regulators in the oversight of COVID-19 vaccines.  It explains how vaccines undergo robust scientific evaluation to determine their safety, efficacy and quality and how safety is closely and continually monitored after approval.

Vaccination has been shown to contribute to reducing deaths and severe illness from COVID-19, and to reduce the transmission of COVID-19.  Vaccinating as many people as possible and reducing the spread of disease is important.  Vaccination of a significant proportion of the population also protects vulnerable people, including those who cannot receive vaccines, or the small proportion of people who might remain at risk of infection after vaccination. Failure to vaccinate widely also enables continued circulation of the virus and the generation of variants, including some that may pose a greater risk. Widespread vaccination will help prevent people from having to go to hospital and contribute to fewer people getting sick, ultimately alleviating the burden of COVID-19 on healthcare systems. It will also help allow a return to normal societal functioning and the re-opening of economies.

Vaccines and the regulatory process

How do regulatory authorities evaluate COVID-19 vaccines?

Regulators rigorously evaluate scientific and clinical evidence provided by vaccine manufacturers. Vaccine manufactures are legally obliged to follow defined standards in the data they provide, and their clinical research and manufacturing operations are subject to regulatory oversight. Either full or summary data from clinical trials is made available following vaccine evaluation. Each vaccine is thoroughly assessed for safety, efficacy and pharmaceutical quality to determine whether it can be approved for use.  Regulators use available scientific evidence from preclinical laboratory research, human clinical trials, and manufacturing information to assess benefits and risks of candidate vaccines.

Regulators may seek additional expert advice from independent scientific advisory committees to help inform their decision on whether to approve a vaccine. These committees are made up of experts in science, medicine (including infectious diseases) and public health, and often include consumer and healthcare professional representatives.

Public health agencies have a different role than regulatory authorities.  They develop and deliver vaccination programmes, often working with their expert immunisation technical advisory committees. This includes prioritising and designating populations for vaccination with specific vaccines, issuing additional recommendations and providing information more broadly about vaccines and immunization. They also collaborate with regulators to monitor the safety of vaccines after they are approved for use.

Globally, the public can have confidence in the rigour of the process used to scientifically evaluate the safety, efficacy and quality of vaccines before they are approved for use in the wider population. 

Safety evidence prior to potential regulatory authorisation:

Safety evidence is an essential part of each regulatory submission for a COVID-19 vaccine. It is gathered during all phases of the vaccine development process. Robust assessment of safety is carried out in the clinical trials and submitted to regulators for review as part of the approval process.

All adverse events need to be examined and reported in the regulatory submission by the companies for a marketing licence. Typically, regulators will require that participants in clinical trials have been followed for at least 1-2 months after receiving their final vaccine dose.  Generally, based on previous experience with vaccines, most adverse events occur within such timeframes, though rare adverse events might not be recognised until after wide population use. There will also be longer-term (for example for 6-12 months or more) follow-up of those who participated in the earlier phases of the clinical trials of each vaccine. Many trial participants will also be followed for at least one year to assess the duration of protection and longer-term safety of individual vaccines, and safety data from these longer-term trials will be carefully reviewed by regulators as part of post-approval monitoring of safety.

Efficacy:

Apart from information on the types of immune responses induced by the vaccine, companies must submit data from well-designed clinical trials to regulators to demonstrate that the vaccine prevents COVID-19.  The data showed there were sufficient numbers of people included in the clinical trials receiving the vaccine so that the efficacy of the vaccine can be accurately measured (generally at least 10 000 and usually 15 000 or more people who receive the vaccine, in addition to those in the control arm). Populations in clinical trials should include a range of age groups and people with co-morbidities.  Given the disproportionate impact of COVID-19 on older people, COVID-19 vaccine clinical trials have included significant numbers of older participants. 

Vaccine clinical trials for a new candidate vaccine showed that vaccines very significantly reduced COVID-19 in people who were vaccinated, compared to a control group of people who did not receive the vaccine, through a reduction in numbers of laboratory confirmed SARS-CoV-2 infections. 

Quality:

Any COVID-19 vaccine that receives regulatory authorisation must be manufactured according to internationally accepted stringent regulatory standards of good manufacturing practices (GMP). Regulators review data to confirm that the manufacturing process at each production site is well-controlled and consistent. This will include data on the composition and purity of the vaccine and its potency, as well as data on every step of manufacturing and on the controls used to ensure that each batch of vaccine is consistently of a high quality. Data on vaccine stability must also be provided before a vaccine can be approved. After approval, batches may also undergo evaluation by individual national regulatory authorities to ensure they meet national requirements, before they can be supplied.

Monitoring safety and effectiveness after vaccine approval:

After a vaccine is approved for use, regulators conduct robust effectiveness monitoring as well as monitoring of safety and risk minimisation activities (pharmacovigilance). They need to continuously monitor vaccine safety to ensure that the benefits of the vaccine continue to outweigh the risks. Regulators do this by:

• Reviewing and analysing adverse events reported by healthcare professionals and consumers and requiring industry vaccine companies (sometimes called “sponsors”) to report to regulators on adverse events received both within the regulator’s home country and globally;
• Many regulators will implement enhanced passive surveillance systems. These include systems to rapidly compare numbers of suspected side effects reported with vaccines to the numbers of events expected to occur by chance, and include access to near real-time data on vaccine usage in different settings. Several regulators also implemented traceability systems for different vaccine brands and batches;
• Taking rapid action to mitigate risks, also considering the information about emerging safety issues shared among regulators and researchers through international collaboration;
• Reviewing medical literature and other sources of new safety information;
• Requiring vaccine manufacturers to continue safety surveillance from the ongoing clinical trials of their products; and
• Many regulators also require vaccine manufacturers to have risk management plans describing how they will monitor and minimise risks, including further epidemiological studies, associated with their vaccines.

It is very important that healthcare professionals not only diligently report any adverse events they see in their patients, but also encourage people who are vaccinated to immediately report adverse events to their healthcare professionals or to the medicines regulator in countries where direct reports from members of the public are accepted by the regulator.  Reporting all relevant events helps regulators assess the possible role of the vaccine in causing the adverse event and assists in identifying safety issues relating to newly introduced vaccines.

As part of the safety monitoring and review of all suspected side effects reporting for vaccines, regulators have developed lists of “Adverse Events of Special Interest”. These lists include some events that have been associated with other vaccines (for example anaphylaxis). Others are included on these lists because they are serious events that are important to monitor extremely closely, even though there is no evidence that they are causally associated with specific vaccines. Having information on the background rates of these events that would be expected in people who have not received a vaccine will help ensure that any increased reporting of these events can be quickly detected and thoroughly investigated by regulators.

The widespread use of COVID-19 vaccines, including in the elderly and in patients with underlying health conditions, will unfortunately mean that there will be deaths and serious illnesses that are purely coincidental and unrelated to vaccinations.  The job of each regulator, together with the relevant medical experts  and vaccine manufacturers is to determine causality. There will be a special focus on monitoring safety in some groups of people, such as pregnant women, persons with severe pre-existing illness, older people, children, and in people also receiving vaccines for prevention of other diseases.

Regulators, often in collaboration with public health authorities, are able to take decisive action if a safety issue is identified. These actions might include: issuing safety communications for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine; preventing the release of a particular batch of vaccine; and, taking other regulatory actions such as restriction of vaccine authorisation to a particular subgroup of the community or revocation of authorisation.

Commonly reported adverse events

The most commonly-reported events with COVID-19 vaccines are expected vaccine side effects, such as headache, fatigue, muscle and joint pain, fever and chills and pain at the site of injection. The occurrence of these adverse events is consistent with what is already known about the vaccines from clinical trials. 

Adverse events of special interest

Regulators approve and maintain an approval of a vaccine only if they determine that the known and potential benefits of the vaccine outweigh its known and potential risks.

Anaphylaxis is a very rare side effect that may occur with any vaccine. There have been some other reported adverse events which include facial weakness, seizures, loss of sense of taste or small and cardiac events, but none are confirmed to be causally related to the vaccines.

mRNA vaccines

The major adverse event of special interest reported for these vaccines, which include the Pfizer and Moderna vaccines is anaphylaxis. Regulators carefully review the reports of possible anaphylaxis to determine whether they are consistent with true anaphylaxis and whether they may have been caused by the vaccine. Anaphylaxis reports remains very rare (in the order of 10 cases per million vaccinated).

Guidance on the management of possible anaphylaxis is included in the Product Information/Label for these vaccines. Routine vaccination procedures include keeping people under observation for at least 15 minutes after vaccination and having appropriate medical treatment on hand so that anaphylaxis can be rapidly managed. These vaccines should not be given to people with a known history of a severe allergic reaction to any of the vaccine components. A second dose of mRNA vaccine should not be given to those who have experienced anaphylaxis to the first dose.

There have been some other reported adverse events, which include unusual bleeding and blood clotting disorders, facial weakness, seizures, loss of sense of taste or smell and cardiac events. Regulators monitor and carefully review if there is a causal relationship between the vaccines with those adverse events, and, if appropriate, they will be included in Product Information / Product Label of vaccines of concern.

Adenovirus vector vaccines

These include the AstraZeneca, Janssen, Gamaleya and CanSino Biologics vaccines. Internationally, the AstraZeneca and Janssen COVID-19 vaccines have been associated with a very rare and unusual clotting syndrome involving thromboembolic events (blood clots) with thrombocytopenia (low blood platelet count). This condition has been termed Thrombosis with Thrombocytopenia Syndrome (TTS). Medicines regulators are meeting regularly to share information about cases to better characterise this risk and understand this syndrome. Less information is available internationally about adverse events following the Gamaleya and CanSino Biologics vaccines.

The overall number of reports received of blood clots in the veins or arteries (including venous thrombosis or venous thromboembolism) occurring without thrombocytopenia is no higher than the expected background population rate for the more common type of blood clots in most countries.

The spontaneous reporting rates of thromboembolic events with thrombocytopenia vary by country and the precise incidences are difficult to estimate, but for the AstraZeneca vaccine, based on substantial use in Europe and the UK, the frequency of such events is very rare. Available estimates are of the order of 10-15 per million people vaccinated (note that for some countries this statistic is based on the numbers of reports of suspected cases of TTS rather than numbers of confirmed cases). Thromboembolic events with thrombocytopenia have also been reported in the United States for the Janssen vaccine, at a rate of about 2-3 per million doses administered. National regulators are continuing to monitor the issue closely and to publish up to date information on the numbers of cases reported and the latest estimates of the incidence.

The cases of thromboembolic events with thrombocytopenia after vaccination were mainly reported for younger rather than older individuals. This, together with the risk of serious illness or death associated with COVID-19 being much higher in middle-aged and older people, has led public health authorities in some countries to recommend that vaccination with the Astra Zeneca vaccine not be initiated in younger individuals.

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia as well as coagulopathies after vaccination as TTS requires specific management. Vaccinated individuals should be instructed to seek immediate medical attention if they develop symptoms such as a severe or persistent headache, blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain or unusual skin bruising and/or petechiae (tiny purple, red, or brown spots on the skin) mostly occurring within around 4-20 days after vaccination, although some cases have been reported later than 20 days post vaccination.  This information is in the Product Information / Product Label of the vaccines as approved by regulators.

 Questions and Answers on COVID-19 vaccines

Q: How have the vaccines been developed so quickly? Does this mean that their safety and efficacy has been compromised?

A: The speed of development of COVID-19 vaccines has been unprecedented for several reasons, but the safety and efficacy requirements for vaccines have not been compromised, Vaccine development was facilitated by:

• The massive financial investment by governments, industry and philanthropic organisations in vaccine development and the re-direction of much of the global research and commercial infrastructure for the development and manufacture of vaccines. Governments also enabled companies to take the commercial risk of manufacturing some vaccine stocks ahead of regulatory approvals.
• New technologies adapted from the development of other vaccines – mRNA vaccines were developed for COVID-19 very rapidly after the sequence of the COVID-19 virus was determined, but the underlying technology had been under development since much longer and production could be scaled up very quickly. The adenovirus technology used for adenovirus vector vaccines was first tested with SARS, MERS and Ebola virus over the last 20 years, and so was able to be adapted quickly to COVID-19, which has several similarities to these viruses.
• Clinical trial successes - it has been possible to rapidly recruit large numbers of volunteers into clinical trials and, with unfortunately high rates of infection in several countries, to complete trials with 10,000-50,000 people in a short period of time. Under normal circumstances, it may take many months or even a few years to carry out trials of this size to determine whether a vaccine is effective.
• Very close collaboration - between regulators, industry and clinical researchers enabled clear indications of regulatory requirements and early access to results. 
• Intensive and insightful research - researchers predicted that the “spike protein” on the virus would be a good target for vaccine development, and almost all vaccines have been designed to induce a response to this protein.  So far, the spike protein has produced a strong immune response in those vaccinated, and for those vaccines that have reported clinical results are highly protective from COVID-19 disease.

Q: Will mRNA vaccines affect the DNA of vaccine recipients?

A: No. The mRNA in the vaccine has not been shown to incorporate itself into the genes of vaccine recipients and breaks down in the weeks after vaccination. mRNA vaccines contain genetic instructions for our cells, which only read them and provide copies of the SARS-CoV2 spike protein. This enables the body’s natural immune systems to cause a response in vaccine recipients if they are later exposed to the virus.

Q:  How long will COVID-19 vaccination provide protection for immunised people?

A:  We do not yet know how long protection from any of these vaccines lasts.  We will get better insights over the next 12 months.

• The duration of protection provided by vaccines can vary. For example, the seasonal influenza vaccine is given annually, because the influenza virus mutates, and protection wanes over a number of months. Other vaccines, such as those for rubella or measles provide multi-year or even life-long protection from disease. Mutations in key viral proteins can mean that virus variants emerge. The SARS-CoV-2-coronavirus is prone to mutations that creates variants, some of which have become established in a number of regions of the world. The scientific community and regulators are very actively monitoring whether the current vaccines can continue protecting people from infection with new variants.
• A number of vaccine developers are currently developing vaccines against the range of variants, and it is likely that booster shots with these vaccines will increase protection against known variants. Regulators have agreed that review of data on vaccines against variants will be facilitated based on assessment of immune response to the variant, in the same way that new seasonal influenza vaccines are evaluated each year.

Q: Why are there so many vaccine candidates?

A: As the global seriousness of the pandemic became rapidly apparent, development of effective vaccines for COVID-19 became the top priority of many pharmaceutical companies and medical research institutes. There was also unprecedented government and private sector investment in vaccine development.  There is now a wide range of technologies for developing new vaccines - and many of the organisations developing COVID-19 vaccines have particular experience in one or more of these technologies. This has ensured that there would still be vaccines available if some were not approved for reasons of efficacy, safety or manufacturing challenges.

Q: What if many people start getting a reaction from a particular COVID-19 vaccine?

A: Short-term reactions, such as soreness at the injection site, fatigue or headache are common following any vaccination with COVID-19 vaccines. These reactions usually pass in a day or two. If new evidence becomes available that suggests that a specific serious adverse event may be linked to a particular COVID-19 vaccine then regulators will take action, working collaboratively on a global basis and liaise with public health authorities. The type of actions that can be taken depend on the nature of the adverse event, and could range from issuing safety warnings for patients, healthcare professionals and the community; updating the product information or consumer information for the vaccine to show contraindications for the use in particular patients (e.g. those with certain co-morbidities); to closely monitoring adverse events in certain groups of patients; preventing the release of a particular batch of vaccine through to temporary suspension of the use of the vaccine until more is known.

Q: How are regulators speeding up the time it takes to authorise a COVID-19 vaccine?

A: Many regulators globally have implemented faster access pathways for COVID-19 vaccines, without compromising on strict standards of safety, quality and efficacy.

• Some countries have Emergency Use Authorisation pathways which assess the available data at the time of authorisation.  Exercising these provisions is a matter for those countries, taking into account the benefits versus risks in the context of the prevailing domestic pandemic situation. Different countries may coin this pathway or authorisation routes differently but essentially, they follow the same principles.
• Other countries have implemented accelerated/priority, conditional or provisional approval schemes.
• Under normal circumstances, regulatory assessment begins once all information to support registration is available. For COVID-19 vaccines, many regulators have agreed to accept data on a rolling basis to enable early evaluation of data as it becomes available. Regulators will only be in a position to make a provisional approval decision for a vaccine once there is sufficient data to support adequately the safety, quality and effectiveness of the vaccine for its intended use. If a decision is made to grant provisional or conditional approval, it will be based on the requirement for the sponsor to submit more comprehensive, longer term clinical data, stability data and other information with agreed timelines.

Q: Did our country approve this COVID-19 vaccine, or are we relying on another country’s approval?

A: Most countries are carrying out independent regulatory evaluations on the submitted data for each vaccine. However, to ensure a more efficient use of resources and expertise, regulators in different countries are communicating closely on safety, efficacy and quality data and discussing technical issues as they may arise. In many cases principles of WHO Good Reliance Practices and collaborative mechanisms leverage the output of other regulators. 

Q: Why weren’t very rare blood clots with low platelets with the AstraZeneca or Janssen vaccines picked up during clinical trials?

A: Thromboembolic events with concurrent thrombocytopenia are very rare – with estimates based on the number of spontaneous reports suggesting an overall incidence on the order of 10-15 cases per million doses. The clinical trials of these vaccines included large numbers of people, often with 10,000 to 20,000 individuals in the active vaccine arms, but even in trials of this size it was statistically unlikely that such very rare events would be detected.  This shows the importance of continual safety monitoring during the use of these vaccines, to allow very rare events to be detected and investigated further.  

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About ICMRA

ICMRA brings together the heads of 30 medicines regulatory authorities* from every region in the world, with the WHO as an observer.  Medicines regulators recognise their role in facilitating access to safe and effective high-quality medicinal products essential to human health and well-being.  This includes ensuring that benefits of vaccines outweigh their risks.

ICMRA is an international executive-level coalition of key regulators from every region in the world. It provides a global strategic focus for medicines regulators and gives strategic leadership on shared regulatory issues and challenges. Priorities include coordinated response to crisis situations.

Members of ICMRA include: Therapeutic Goods Administration (TGA), Australia; National Health Surveillance (ANVISA), Brazil; Health Products and Food Branch, Health Canada (HPFB-HC), Canada; China National Medical Products Administration (NMPA), China; European Medicines Agency (EMA) and European Commission - Directorate General for Health and Food Safety (DG - SANTE), European Union; French National Agency for Medicines and Health Products Safety (ANSM), France; Paul-Ehrlich-Institute (PEI), Germany; Health Product Regulatory Authority (HPRA), Ireland; Italian Medicines Agency (AIFA), Italy; Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Ministry of Food and Drug Safety (MFDS), Korea; Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Mexico; Medicines Evaluation Board (MEB), Netherlands; Medsafe, Clinical Leadership, Protection & Regulation, Ministry of Health, New Zealand; National Agency for Food Drug Administration and Control (NAFDAC), Nigeria; Health Sciences Authority (HSA) Singapore; Medicines Control Council (MCC), South Africa; Medical Products Agency, Sweden; Swissmedic, Switzerland; Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom; Food and Drug Administration (FDA), United States.

Associate members include: Argentina national Administration of Drugs, Foods and Medical Devices (ANMAT); Austrian Medicines and Medical Devices Agency (AGES), Colombia National Food and Drug Surveillance Institute (INVIMA); Cuba Center for State Control of Medicines, Equipment and Medical Devices (CECMED); Danish Medicines Agency (DKMA); Israel Ministry of Health (MOH); Poland Office of Registration of Medicinal Products and Biocidal Products (URPLWMiPB); Portugal National Authority of Medicines and Health Products (INFARMED); Russia Federal Service for Surveillance in Healthcare (Roszdravnadzor); Saudi Food and Drug Authority (SFDA); Spanish Agency of Medicines and Medical Devices (AEMPS).

About the World Health Organization

The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from 149 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing. 

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