top of page
Search

COVID-19 VACCINE & PEOPLE LIVING WITH HIV

Updated: May 21, 2021

Since the beginning of the pandemic of COVID-19, the world has been scrambling around trying to understand more about COVID-19. Recommendations from the CDC, national policies have been turned upside down and even revised multiple times. The only unchanged and unfazed constant is that vaccines were being rushed into production. Rushing into production is it a bad or a good thing?


The development of vaccines produced against the COVID-19 virus has never seen a vaccine produced at such a speed. Ex-president Donald J. Trump coined the word "Operation Warp-Speed". As always Donald was good at giving names to his campaigns and name-calling people but the terms he used this time was very "Sci-fi" and appropriate. Pharmaceutical companies were driving themselves to be the first company to be the fastest producer of the COVID-19 vaccine. Some companies had significant gains and some lost the race. So far major companies like Moderna, Pfizer, and J&J (Johnson & Johnson) made the cut with good evidence. What about other vaccines like the UK Astrazeneca, Novavax, Russian Sputnik-V or the China Sinovac? How do they fair?


So how do we compare these vaccines? You need to be aware that most of these vaccines' efficacy is good on clinical trials and looks good on paper, however in reality they may fair differently when the vaccines reach the arms of the general public. Meaning a vaccine can show the efficacy of 95% on clinical trial but when it reaches the general public's arms, the efficacy may be lower or higher than the clinical trial.


Currently, 3 vaccines are approved by the FDA (Food and Drug Association) is Pfizer, Moderna, and Johnson & Johnson vaccines.



What are the phases of a clinical study?

The phases of the clinical study are to determine the efficiency, mechanism, metabolism, excretion, and safety of a drug or vaccine. Each phase is used to determine different objectives. In short, a clinical study which studies experimented drug on a population to evaluate the efficacy, mechanism, metabolism, excretion, and safety of a drug.



Can PLHIV or People Living with HIV take the COVID-19 Vaccine?

Since this vaccine is still new and is approved for emergency use. There is still limited data about people living with HIV taking the vaccines. However, there is a small HIV population included in the study for the Pfizer and Moderna vaccine.



Is the Pfizer COVID-19 vaccine safe for people living with HIV?

In order to know the safety profile of the Pfizer vaccine, you will have to understand the process of the Pfizer COVID-19 vaccine clinical study and the steps to approve the vaccine for use.


How was the Pfizer trial conducted?

The Pfizer trial included 120 people with HIV. The Pfizer study design for HIV patients was not initially included in Phase 1 but they entered the study later at Phase 2 and 3. The chart below shows the inclusion of participants living with HIV in Phase 2.


What are the criteria of the Pfizer COVID study to include people living with HIV?

The participants were people living with HIV with stable HIV disease defined as:

  1. Viral load <50 copies/mL (within 6 months)

  2. CD4 count >200cell/mm3 (within 6 months)

  3. On treatment (> 6 months)



Why did people living with HIV not included in the Phase 1 study but recruited later in Phase 2 and 3 study?

We have no clear picture of the reason why Pfizer did not include HIV-positive participants in the phase 1 trials.


Pfizer then amended their study to include PLHIV with chronic stable HIV into phases 2 and 3 to establish efficacy and safety. This is a bold and inclusive move of Pfizer for this special group because people living with HIV are also considered as a high-risk population of acquiring COVID-19.



How did Pfizer monitor people living with HIV after they were vaccinated?

The participants who were HIV positive were asked to keep an electronic diary about any local or systemic or reactivity to the vaccine. This information is directly transferred to the investigator and recorded. The participants were on follow-up at an interval for their HIV viral load and CD4 count. The intervals are:

  1. Day 1 (1st dose)

  2. D19-23 (2nd dose)

  3. D175-189 (from 2nd dose)

  4. D359-378 (from 2nd dose)

  5. D714-742 (from 2nd dose)

This process ensures the safety and early reporting of reactivity of the vaccine to those participants who are HIV-positive.



Is the Pfizer vaccine safe and effective for people living with HIV?

Yes. The Pfizer vaccine has been proven to be safe and effective. In the HIV-positive group, there were no reported life-threatening events or serious adverse reactions. Local swelling and redness were reported in their participants but nothing severe in the HIV-positive population. I will surely support the use of the Pfizer vaccine in people living with HIV if their disease is stable:

  1. Viral load <50 copies/mL (within 6 months)

  2. CD4 count >200cell/mm3 (within 6 months)

  3. On treatment (> 6 months)




Is the Moderna COVID-19 vaccine safe for people living with HIV?

In order to know the safety profile of the Moderna vaccine, you will have to understand the process of the Moderna COVID-19 vaccine clinical study and the steps to approve the vaccine for use.


How was the Moderna trial conducted?

The Moderna trial included 176 people with HIV. In that study, one HIV-positive person in the placebo group and none in the vaccine group developed symptomatic COVID-19. No unusual safety concerns were reported for people with HIV.


This Chart is Moderna's clinical study on the inclusion of people living with HIV. They included 176 participants who were living with HIV out of the total 30350 participants.


What is the efficacy of the Moderna vaccine for people living with HIV?

</