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What do we know so far about how the U.K. is approving and rolling out vaccines?

This article was published on
April 21, 2021

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**Approval status:** On December 2, 2020, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted an emergency-use authorization to a 2-dose mRNA vaccine developed by Pfizer and BioNTech, roughly seven months after the clinical trials started. Other vaccine candidates are currently under review by the regulator. **Approval processes:** In the United Kingdom, vaccines are approved by the regulator (the MHRA) based on criteria including safety, quality, and efficacy. The MHRA has been using a "rolling review" process since June 2020 to assess COVID-19 vaccines in an accelerated timeframe, with teams of scientists often requesting and reviewing data on various topics in parallel. The European Union (EU) requires vaccines to be authorized by the European Medicines Agency (EMA), but allows individual countries to use an emergency procedure to distribute a vaccine for temporary use in their domestic market. The MHRA chief executive stated that they used this existing EU provision to fast-track approval in the U.K. before the rest of the EU, since the U.K. is still subject to EU rules until their transition period for leaving is completed on December 31, 2020. **Distribution status:** The U.K. announced that 357 million doses of seven different vaccines have been purchased, which includes 40 million doses of the Pfizer and BioNTech vaccine. An initial delivery of 800,000 doses of the Pfizer and BioNTech vaccine (which can provide two doses to 400,000 people) was received from a manufacturing site in Belgium, and was divided between the four countries of the U.K. on the basis of population (with most going to England and Wales, 65,500 doses going to Scotland, and 25,000 doses going to Northern Ireland). The first vaccinations outside of trials in the U.K. began on December 8, 2020, prioritizing residents and caretakers in care homes for older adults (also known as aged-care). A 90-year-old woman was the first person outside of trials to receive a vaccine dose in her country. **Distribution priorities:** The U.K. Joint Committee on Vaccination and Immunisation (JCVI) identified that the first phase of vaccinations should focus on directly preventing mortality and supporting the National Health Service (NHS) as well as the social care system. This first phase includes nine priority groups, which taken together are estimated to represent 99% of preventable mortality: 1. Residents in a care home for older adults and their carers 2. All those 80 years of age and over and frontline health and social care workers 3. All those 75 years of age and over 4. All those 70 years of age and over and clinically extremely vulnerable individuals 5. All those 65 years of age and over 6. All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality 7. All those 60 years of age and over 8. All those 55 years of age and over 9. All those 50 years of age and over The next phase of vaccinations will focus on further reducing hospitalization and targeting those at high risk of exposure and/or those delivering key public services. This next phase is likely to include people at increased risk of exposure to COVID-19 due to their occupation, such as first responders, the military, those involved in the justice system, teachers, transport workers, and public servants essential to the pandemic response. **Distribution processes:** The Pfizer and BioNTech vaccine requires storage in ultra-cold temperatures of -70 degrees Celsius. A shipping box has been developed that is packed with dry ice to maintain the necessary temperature for 5,000 doses, which can be transported by airplane. Once the doses arrive in the target country, the country can store the dry ice packs in a freezer farm for up to 6 months. If unopened, the dry ice packs can keep the doses cold for up to 10 days during transport. After the vaccine is thawed, it can be stored for up to 5 days at between 2 and 8 degrees Celsius. The U.K. Security Service (MI5) and National Cyber Security Centre (NCSC) are working to provide security for the vaccine supply chain and distribution, which could be disrupted by hacking and other attacks. The U.K. Ministry of Defence has announced that it is providing 60 military planners to work with the government's vaccine task force and 56 personnel to help construct vaccination centers. The U.K. Armed Forces Minister announced that more than 2,000 military personnel have been deployed so far to help with testing and other COVID-19 response, and that 13,500 military personnel remain on "high readiness" to provide support. In England, 50 NHS hospitals are serving as initial hubs for administering the vaccine.

**Approval status:** On December 2, 2020, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted an emergency-use authorization to a 2-dose mRNA vaccine developed by Pfizer and BioNTech, roughly seven months after the clinical trials started. Other vaccine candidates are currently under review by the regulator. **Approval processes:** In the United Kingdom, vaccines are approved by the regulator (the MHRA) based on criteria including safety, quality, and efficacy. The MHRA has been using a "rolling review" process since June 2020 to assess COVID-19 vaccines in an accelerated timeframe, with teams of scientists often requesting and reviewing data on various topics in parallel. The European Union (EU) requires vaccines to be authorized by the European Medicines Agency (EMA), but allows individual countries to use an emergency procedure to distribute a vaccine for temporary use in their domestic market. The MHRA chief executive stated that they used this existing EU provision to fast-track approval in the U.K. before the rest of the EU, since the U.K. is still subject to EU rules until their transition period for leaving is completed on December 31, 2020. **Distribution status:** The U.K. announced that 357 million doses of seven different vaccines have been purchased, which includes 40 million doses of the Pfizer and BioNTech vaccine. An initial delivery of 800,000 doses of the Pfizer and BioNTech vaccine (which can provide two doses to 400,000 people) was received from a manufacturing site in Belgium, and was divided between the four countries of the U.K. on the basis of population (with most going to England and Wales, 65,500 doses going to Scotland, and 25,000 doses going to Northern Ireland). The first vaccinations outside of trials in the U.K. began on December 8, 2020, prioritizing residents and caretakers in care homes for older adults (also known as aged-care). A 90-year-old woman was the first person outside of trials to receive a vaccine dose in her country. **Distribution priorities:** The U.K. Joint Committee on Vaccination and Immunisation (JCVI) identified that the first phase of vaccinations should focus on directly preventing mortality and supporting the National Health Service (NHS) as well as the social care system. This first phase includes nine priority groups, which taken together are estimated to represent 99% of preventable mortality: 1. Residents in a care home for older adults and their carers 2. All those 80 years of age and over and frontline health and social care workers 3. All those 75 years of age and over 4. All those 70 years of age and over and clinically extremely vulnerable individuals 5. All those 65 years of age and over 6. All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality 7. All those 60 years of age and over 8. All those 55 years of age and over 9. All those 50 years of age and over The next phase of vaccinations will focus on further reducing hospitalization and targeting those at high risk of exposure and/or those delivering key public services. This next phase is likely to include people at increased risk of exposure to COVID-19 due to their occupation, such as first responders, the military, those involved in the justice system, teachers, transport workers, and public servants essential to the pandemic response. **Distribution processes:** The Pfizer and BioNTech vaccine requires storage in ultra-cold temperatures of -70 degrees Celsius. A shipping box has been developed that is packed with dry ice to maintain the necessary temperature for 5,000 doses, which can be transported by airplane. Once the doses arrive in the target country, the country can store the dry ice packs in a freezer farm for up to 6 months. If unopened, the dry ice packs can keep the doses cold for up to 10 days during transport. After the vaccine is thawed, it can be stored for up to 5 days at between 2 and 8 degrees Celsius. The U.K. Security Service (MI5) and National Cyber Security Centre (NCSC) are working to provide security for the vaccine supply chain and distribution, which could be disrupted by hacking and other attacks. The U.K. Ministry of Defence has announced that it is providing 60 military planners to work with the government's vaccine task force and 56 personnel to help construct vaccination centers. The U.K. Armed Forces Minister announced that more than 2,000 military personnel have been deployed so far to help with testing and other COVID-19 response, and that 13,500 military personnel remain on "high readiness" to provide support. In England, 50 NHS hospitals are serving as initial hubs for administering the vaccine.

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Approval status: On December 2, 2020, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted an emergency-use authorization to a 2-dose mRNA vaccine developed by Pfizer and BioNTech, roughly seven months after the clinical trials started. Other vaccine candidates are currently under review by the regulator.

Approval processes: In the United Kingdom, vaccines are approved by the regulator (the MHRA) based on criteria including safety, quality, and efficacy. The MHRA has been using a "rolling review" process since June 2020 to assess COVID-19 vaccines in an accelerated timeframe, with teams of scientists often requesting and reviewing data on various topics in parallel. The European Union (EU) requires vaccines to be authorized by the European Medicines Agency (EMA), but allows individual countries to use an emergency procedure to distribute a vaccine for temporary use in their domestic market. The MHRA chief executive stated that they used this existing EU provision to fast-track approval in the U.K. before the rest of the EU, since the U.K. is still subject to EU rules until their transition period for leaving is completed on December 31, 2020.

Distribution status: The U.K. announced that 357 million doses of seven different vaccines have been purchased, which includes 40 million doses of the Pfizer and BioNTech vaccine. An initial delivery of 800,000 doses of the Pfizer and BioNTech vaccine (which can provide two doses to 400,000 people) was received from a manufacturing site in Belgium, and was divided between the four countries of the U.K. on the basis of population (with most going to England and Wales, 65,500 doses going to Scotland, and 25,000 doses going to Northern Ireland). The first vaccinations outside of trials in the U.K. began on December 8, 2020, prioritizing residents and caretakers in care homes for older adults (also known as aged-care). A 90-year-old woman was the first person outside of trials to receive a vaccine dose in her country.

Distribution priorities: The U.K. Joint Committee on Vaccination and Immunisation (JCVI) identified that the first phase of vaccinations should focus on directly preventing mortality and supporting the National Health Service (NHS) as well as the social care system. This first phase includes nine priority groups, which taken together are estimated to represent 99% of preventable mortality: 1. Residents in a care home for older adults and their carers 2. All those 80 years of age and over and frontline health and social care workers 3. All those 75 years of age and over 4. All those 70 years of age and over and clinically extremely vulnerable individuals 5. All those 65 years of age and over 6. All individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality 7. All those 60 years of age and over 8. All those 55 years of age and over 9. All those 50 years of age and over

The next phase of vaccinations will focus on further reducing hospitalization and targeting those at high risk of exposure and/or those delivering key public services. This next phase is likely to include people at increased risk of exposure to COVID-19 due to their occupation, such as first responders, the military, those involved in the justice system, teachers, transport workers, and public servants essential to the pandemic response.

Distribution processes: The Pfizer and BioNTech vaccine requires storage in ultra-cold temperatures of -70 degrees Celsius. A shipping box has been developed that is packed with dry ice to maintain the necessary temperature for 5,000 doses, which can be transported by airplane. Once the doses arrive in the target country, the country can store the dry ice packs in a freezer farm for up to 6 months. If unopened, the dry ice packs can keep the doses cold for up to 10 days during transport. After the vaccine is thawed, it can be stored for up to 5 days at between 2 and 8 degrees Celsius.

The U.K. Security Service (MI5) and National Cyber Security Centre (NCSC) are working to provide security for the vaccine supply chain and distribution, which could be disrupted by hacking and other attacks.

The U.K. Ministry of Defence has announced that it is providing 60 military planners to work with the government's vaccine task force and 56 personnel to help construct vaccination centers. The U.K. Armed Forces Minister announced that more than 2,000 military personnel have been deployed so far to help with testing and other COVID-19 response, and that 13,500 military personnel remain on "high readiness" to provide support. In England, 50 NHS hospitals are serving as initial hubs for administering the vaccine.

Context and background

In early December 2020, the U.K. became the first Western country to approve and begin publicly distributing a COVID-19 vaccine that has been tested in large-scale clinical trials. Many nations are watching how the U.K. vaccine rollout develops, as they look to issue their own approvals and implement their own vaccine distribution plans. For example, regulatory agencies in the U.S. and the European Union (EU) are also expected to make decisions about vaccine approvals in December 2020. China and Russia are considered exceptions in having approved and started vaccinating people months earlier, without waiting for results from large-scale clinical trials.

The U.K.'s vaccine distribution plans are happening in the context of a country that has been struggling to control the spread of COVID-19 thus far. According to the World Health Organization, as of December 8, 2020, there have been 1,737,964 confirmed COVID-19 cases with 61,434 deaths in the U.K.

Resources

  1. The UK has approved a COVID vaccine — here’s what scientists now want to know (Nature)
  2. How the U.K. Approved Pfizer's COVID-19 Vaccine Faster Than the U.S. and Europe (Time)
  3. Priority groups for coronavirus (COVID-19) vaccination: advice from the JCVI, 2 December 2020 (JCVI)
  4. How the U.K. Plans to Lead the World in Covid Vaccination (Bloomberg)
  5. Coronavirus: Hackers targeted Covid vaccine supply 'cold chain' (BBC)
  6. Covid: Military could be used to transport Covid vaccine (BBC)
  7. The United Kingdom Situation (WHO)

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