Freedom of Information request on COVID-19 vaccinations and human immunodeficiency virus medication (FOI 21-843)
Published 20 January 2022
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26th August 2021
FOI 21/843
Dear
Thank you for your email dated 23 July 2021, in which you requested the following under the Freedom of Information Act:
-
The total number of adverse reactions following COVID-19 vaccination for individuals living with human immunodeficiency virus (HIV) who are taking a combination of drugs consisting of “Rezolsta” (darunavir/cobicistat), emtricitabine and tenofovir disoproxil.
- The nature of the adverse reactions experienced by these individuals, and the brands of COVID-19 vaccination that these individuals received.
- The date the first COVID-19 vaccine was administered to individuals taking the aforementioned combination of HIV medicines in the United Kingdom.
- The length of time, in normal licensing circumstances, that the MHRA would require trial data to prove the safety of vaccines for people taking the aforementioned combination of HIV medicines.
It may first be helpful if we provide you with some background information relating to the Medicines and Healthcare products Regulatory Agency (‘the agency’), the Yellow Card scheme and the work we carry out. We are an executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment are used safely and meet appropriate standards of safety, quality, performance and effectiveness. The MHRA assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM). The reporting of suspected adverse drug reactions (ADRs) by both healthcare professionals and members of the public through the Yellow Card scheme enables the continued monitoring of the benefit/risk balance for medicines following the granting of their licence. More information on our surveillance strategy can be found at the following link:
Regarding questions 1 and 2, we have received a total of 10 reports detailing suspected adverse reactions following COVID-19 vaccination for individuals where it was specified that the individual was taking a combination of drugs consisting of ‘Rezolsta’ (darunavir/cobicistat), emtricitabine and tenofovir disoproxil. It is important to be aware that whilst we ask reporters to provide details of medicines taken in the previous three months this is not mandatory and so will not always be provided. The majority of reactions in these reports are common side-effects of COVID-19 vaccines, such as headache, nausea, joint pain, muscle ache, injection site pain, fatigue, malaise, and pyrexia which are listed in the product information. The limited reports received are indicative of an equivalent safety profile in this population to those who are not receiving ‘Rezolsta’, emtricitabine and tenofovir disoproxil. More information about each of the COVID-19 vaccines approved for use in the United Kingdom can be found on the link provided here: https://coronavirus-yellowcard.mhra.gov.uk/productinformation. A breakdown of the brand of COVID-19 vaccination received in the 10 reports is tabulated below (Table 1).
Table 1. A breakdown of the brand of COVID-19 vaccination received in reports detailing suspected adverse reactions following COVID-19 vaccination for individuals taking a combination of drugs consisting of “Rezolsta” (darunavir/cobicistat), emtricitabine and tenofovir disoproxil.
| Brand of COVID-19 vaccination received | Number of reports | Number of doses administered (first and second) (in millions) |
|---|---|---|
| Pfizer/ BioNTech | 3 | 36.5 |
| Oxford/ AstraZeneca | 7 | 48.6 |
| Total | 10 | 85.1 |
Question 3 does not fall within the MHRA’s remit. I would advise you to contact Public Health England (PHE, enquiries@phe.gov.uk) which may hold the relevant data.
In response to question 4, no clinical trials have been conducted to specifically study the effects of COVID-19 vaccines on individuals receiving HIV medication or combination of medications. However, HIV patients with stable/well-controlled infection were not excluded from COVID-19 vaccine clinical trials and no safety issues have been raised during these trials for anyone taking a combination of drugs consisting of “Rezolsta” (darunavir/cobicistat), emtricitabine and tenofovir disoproxil for HIV treatment. Likewise, no safety issues have been raised during the national vaccination programme and there are no current safety concerns specific to recipients of COVID-19 vaccines who are taking HIV medication.
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division