15-minute observation period after temporary vaccine suspension to speed up the deployment of the booster

• Temporary suspension of the short observation period for Pfizer and Moderna vaccines
• The advice of four UK chief medical officers includes the first, second and second injections and will be kept under review.
• The risk of a serious allergic reaction after vaccination with mRNA vaccines is low – approximately 1 ratio per 100,000 vaccine doses

The 15-minute observation period following a vaccination with Pfizer or Moderna will be temporarily suspended as part of new measures to accelerate the deployment of the booster as part of our emergency response to the rapid spread of the Omicron variant.

Following advice from the UK’s four chief medical officers and the Medicines and Health Products Regulatory Agency’s Human Medicines Commission, the government agreed to implement the temporary measure to help speed up the rollout vaccinations as soon as possible.

The temporary suspension is carried out on the basis of clinical advice that maintaining the 15-minute rule would cause more damage than it can avoid, as its removal will significantly increase the number of people who can be vaccinated in a short period of time. of time.

Each decentralized administration will determine how operationally the notice recommending the suspension will be implemented when it is safe and appropriate to do so.

The risk of a serious allergic reaction after vaccination with mRNA vaccines is low – about 1 ratio per 100,000 vaccine doses – and we now have much more experience administering these vaccines to millions of people. People are normally not seen for 15 minutes after other vaccinations.

MHRA CEO Dr June Raine said:

In light of the rapid spread of the new Omicron variant and the proven effectiveness of booster doses against Omicron, the 15-minute observation period following mRNA vaccines (Pfizer and Moderna) may be waived during the response. emergency to the Omicron variant. This advice includes the first and second doses of vaccine as well as boosters.

The 15-minute post-vaccination observation period will remain in place for the small number of people who may have previously suffered from anaphylaxis or other allergic reactions to a food, insect bite and most medications or vaccines. .

Anaphylaxis and other serious allergic reactions are very rare side effects with COVID-19 vaccines. During this time when the Omicron variant is spreading rapidly, the benefits of vaccinating as many people as possible, which will flow from eliminating the 15-minute wait, far outweigh the very low risks of anaphylaxis.

We continue to closely monitor UK and international data and ask anyone who suspects they have experienced a side effect from their COVID-19 vaccine to report it on the Coronavirus Yellow Card website. Anyone who has symptoms of an allergic reaction such as difficulty breathing, fast heartbeat, or fainting should see an emergency doctor.

Chairman of the Commission on Human Medicines, Professor Sir Munir Pirmohamed said:

The decision to temporarily waive the post-mRNA observation period in specific circumstances comes after the Commission for Medicinal Products for Human Use (CHM) reviewed and reviewed the available yellow card data on anaphylaxis after primary treatment and after the reminders. Data shows that anaphylaxis and other serious allergic reactions are an extremely rare side effect with the COVID-19 vaccine.

Swift action is needed to address the rapid rise in cases of the Omicron variant of COVID-19 and the growing risk to the public and healthcare services.

This temporary measure will contribute to the major task of immunizing the nation before the end of the year.

We encourage everyone who has not yet received their first, second or third dose of a COVID-19 vaccine to come forward as soon as they can.

Dr Mary Ramsay, UKHSA Immunization Officer, said:

With Omicron growing at such a rapid rate, and early data suggesting that two doses of the vaccine are not enough to protect against symptomatic infections, it is vital that we do everything we can to get more hits in more of the arms. as quickly as possible.

Eliminating the 15 minute wait, as agreed by the CHM, will help streamline the process at vaccination centers, and we have updated our guidelines to facilitate this.

Nikki Kanani, GP and NHS Immunization Program Assistant, said:

The updated CMO advisory to temporarily suspend the 15-minute wait – where safe and appropriate – will be especially helpful for small vaccination sites, helping to protect more people as quickly as possible.

As part of the national mission to protect the public against the new Omicron variant, the NHS has put in place measures to speed up its COVID-19 recall program with more contextual vaccination centers planned and extended hours of operation.

Those with a history of allergies, especially to other vaccines, or who had an immediate reaction after a previous dose may be advised to stay for 15 minutes. People are advised to inform the vaccination center if this is the case and to let them know if they have ever fainted after the vaccination.

UK Health Safety Agency updated Green Paper to reflect today’s change [Tuesday December 14]. The updated patient group orientation and protocol will be released shortly.

The change can be implemented after the Green Paper update at sites such as hospitals and GP surgeries and for home visits and the NHS will implement the guidelines as soon as possible at vaccination sites broader once the necessary clinical guidelines are in place.

NOTES TO EDITORS:

• Link to the statement of four UK marketing directors
• The need for the suspension will be considered by the Commission of Human Medicines, MHRA and JCVI depending on the urgency of the vaccination and booster program and monitoring reports of anaphylaxis.
• Instead of waiting 15 minutes after their vaccine, anyone presenting for the vaccine is now asked to adhere to the following guidelines:
  • Avoid leaving the center if you are not feeling well
  • Inform the center if you have a history of allergies
  • Do not drive for 15 minutes after receiving the vaccine
  • If you are vaccinated at home, you may need to make arrangements to have someone with you
  • Make sure the person you are with has a ‘phone available’
  • If you experience a tingling or a tight throat, ask the person you are with to dial 999 or call for help if you are near the vaccination center.