Q&A on COVID vaccines: are they safe and effective?

BAME COVID-19 Immunisation Research

HIV i-Base continue to report on COVID-19 research and treatment as a supplement to HIV treatment research and information.

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Q&A on COVID vaccines: are they safe and effective?

The following questions were for a community UK-CAB workshop on COVID vaccines. Answers by Angelina Namiba and Simon Collins.

Are vaccines against COVID-19 effective?

Yes, any approved vaccine has been very carefully studied in  a wide range of people.

These first vaccines are highly effective. Both the Pfizer and Moderna vaccines prevent COVID symptoms in 95% of people. They also prevent severe COVID-19.

These vaccines are much better than first thought possible. Early in 2020, a vaccine would have been approved if it was only 50% effective.

Which vaccines are being used in the UK?

The only vaccine that is currently approved in the UK is called BNT162b2.

It is made by Pfizer/BioNTech. It was approved in the UK on 2 December and in the US on 12 December 2020. A second similar vaccine, developed by Moderna/NIH has just been approved in the US. It will also be approved in other countries too. The EU plans to approve these two vaccines within the next few weeks.

However, other vaccines are being used in UK studies (see below). These include a vaccine from Oxford University and Astra-Zeneca called ChAdOx1. Another study using a Janssen vaccine is just starting. As new vaccines are approved we will add them to this page.

Why should I get a vaccine?

The main reason to get the vaccine is to protect yourself against COVID-19.

COVID-19 can be deadly – it is much better to be protected. Even people who recover from COVID-19 often have symptoms that last for many months. This is called long COVID and is still being studied.

If you have been offered the vaccine it is because of your personal level of risk. The vaccine may also protect your friends, family and contacts at work.

Is my risk high enough to need the vaccine?

Yes, there is only a limited supply of these vaccines. In the UK, for at least the next few months, you will only be offered the vaccine if your personal risk is high.

This will be because of your age and your health or because you work in a high risk job.

Do I have to get the vaccine?

If the vaccine is for your own health, then this is always still your choice. You do not have to have the vaccine.

Please talk to your doctor if you have any worries or concerns. Or if you’re unsure about having the vaccine.

If you are offered the vaccine because of your job, not having the vaccine might affect the work you can do.

Are vaccines against COVID-19 safe?

Yes, based on the results from large studies, any approved vaccine will also be very safe.

For example. the Pfizer vaccine was studied in more than 44,000 people without any serious side effects.

There are only a few situations when this vaccine needs to been given more carefully. This includes people who have a history of serious allergy reactions to different foods or medicines – as with other vaccines. In this case the vaccine should only be given where there is medical support in case this reaction occurs.

How do we know the vaccine is safe?

Technically, no medicine or vaccine can be proved to be safe! This is because we can’t measure safety, we can only measure risk.

So instead of saying something is safe, it is more accurate to describe the risk. With COVID vaccines we can say there is a very low risk of side effects.

Compared to the very real risks from COVID-19, using the vaccine is much safer than not using it. This is known from research studies in tens of thousands of people. The studies recorded every side effect or any potential side effect.

Additional safety data comes after the vaccines are used outside of studies. This will include from people who were not included in the main studies. This led to a caution in people with history of serious allergic reactions (see next Q).

What if I have a history of allergy reactions?

As in the question above, even people with a history of serious reactions can still use the vaccine. This includes people who have reactions to vaccines, medicines or foods.

However, if you currently need to carry an anti-allergy syringe, you need to be vaccinated in a clinic in case a reaction occurs.

Two health workers in the UK with a history of severe reactions did react to the vaccine. Both people have now recovered. More information will be collected on cases like this.

Can I develop an allergic reaction to the vaccine?

Yes, although the risk is small and relates to your history of allergies.

For the Pfizer vaccine, anyone with a history of severe allergy reactions should have the vaccines in a setting that can safely manage reactions.

What about if I have immune suppression from HIV or cancer treatment?

Yes, the vaccine is still recommended if you are HIV positive or if you have cancer. This is because of the high risk from COVID-19.

Although the leaflet that comes with the vaccine includes talking to your doctor first if you have a reduced immune system, this is not related to a safety of the vaccine. It is because the protection from the vaccine might not be as strong.

This means that even after both doses of the vaccine, it will still be important to be careful, for example by wearing a mask and social distancing.

As more people are vaccinated, researchers will look at responses in people who were not widely included in studies.

What if I have other inflammatory or autoimmune conditions?

As above, the vaccine is still recommended for people living with inflammatory or autoimmune conditions.

In this, it is very similar to getting a flu vaccine. Anyone who can use the flu vaccine can use a vaccine against COVID-19.

These include:

  • Inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus).
  • Inflammatory bowel disease (Crohn’s disease and ulcerative colitis).
  • Psoriasis.
  • Multiple sclerosis.
  • Organ transplant recipients.
  • People on chemotherapy.

This is because of the high risks from COVID-19.

Although many people with these and other complications were not directly studied in vaccine studies, there is no safety concern. As above, the caution is that the vaccine might not be quite as effective.

Ongoing research though will be looking at this.

Does the vaccine interact with other medicines?

No. There are no medicines that can not be used with these vaccines. If you are taking other treatment, there is no need to stop this to have a vaccine.

Although it is good to ask about interactions with current medicines, there are no interactions with the vaccines. If you are worried, it is easy to double-check this with your doctor.

Your doctor will also know your medical history and whether one type of vaccine might be better for you than another.

Could the vaccine interact with my HIV meds?

There are no interactions between the COVID-19 vaccines and HIV meds.

Will my HIV viral load blip when I have the vaccine?

Technically though, there is not enough results from HIV positive people in the first vaccine studies to report this yet, though this will be reported later.

However, based on other vaccines this is unlikely to happen.

Any vaccine has the potential to increase viral load for a short time. This is the same as to any active infection (including flu and colds).  As with the answer to other questions here, it is okay to approach the COVID vaccination as if it was the annual flu vaccine – which is widely recommended for people living with HIV.

If your viral load is generally undetectable any increase is likely to be very small. For example, with the flu vaccine, it might increase from less than 50 to maybe 80 or 100 copies/mL – and only for a few days or a week. This is too low to affect the risk of transmission.

Other vaccines, for example for hepatitis B, don’t cause HIV viral load to blip.

As a guide, unless you get symptoms from the vaccine, your HIV viral load is likely to stay undetectable. If you get symptoms, any small blip is likely to be undetectable again within a week.

Can the vaccine interact with estrogen and/or testosterone treatment?

There are no interactions between the COVID-19 vaccines and estrogen and testosterone.

Are the vaccines safe in pregnancy?

Great question. So far there is little data because pregnancy was an exclusion for the main studies. But if you are pregnant, the vaccine is still recommended.

Also, women will still have become pregnant during these studies – and certainly afterwards. These data will all be collected during the study.

When these data are available they will be widely publicised.

Other studies are looking at vaccine responses during pregnancy.

Are the vaccines safe in children?

So far vaccines have only been studied in people who are aged 16 and over.

Further research is planned to look at younger people.

What is in the vaccine that they are going to offer me?

None of the COVID vaccines in the UK contain any live viruses. There is no risk of catching coronavirus from the vaccine.

The active parts of a vaccine though only use a protein from the outside of the coronavirus. Or they tell your boby how to make these proteins.

This will not cause an infection though.

Vaccines also include other ingredients that help the vaccine work. For example the Pfizer vaccine contains traces of sodium and potassium. This is sufficiently low to still be called sodium-free and potassium-free.

It also contains sucrose and this, together with all other ingredients, is listed on the patient leaflet that you get before the injection. This is also online now if you want to check first (see fruther information in the final question).

How is the vaccine given?

The Pfizer vaccine is given as an injection into your upper arm. A second booster dose is given again, three weeks later. You reach the best protection seven days after the second dose.

Do I still need to social distance after the vaccine?

Yes, so far, it is still better to reduce the risk of catching coronavirus.

A few people might not be protected by the vaccine. We also don’t know how long protection will last. You might also still become infected without symptoms. You could then pass this to other people.

Even after the vaccine, please continue wearing a mask. Please continue recommendations for social distancing.

Can I get COVID-19 from the vaccine?

No. This is easy to answer.

There is zero risk of getting COVID-19 from the vaccine.

The vaccines do not contain coronavirus itself.

What are the symptoms/side effects from the vaccine?

Most side effects to the Pfizer vaccine were mild or moderate.

Very common side effects were similar to getting the flu vaccine. They generally got better within a few days. These were reported by more than 1 in 10 people.

  • Pain at injection site.
  • Tiredness.
  • Headache.
  • Muscle pain.
  • Chills.
  • Joint pain.
  • Fever.

Common side effects included injection site swelling, redness at injection site, and nausea. These were reported in less than 1 in 10 people.

Uncommon side effects, in less than 1 in 100 people included enlarged lymph glands or just generally feeling unwell.

Am I going to get sick with the COVID-19 vaccine like the flu jab?

No necessarily, but maybe. So far the COVID vaccine is similar to getting a flu vaccine. And just like the flu vaccine, the response will vary for different people.

The question above shows that symptoms are similar to the flu vaccine and are nearly always mild.

Should I wait to see how people similar to me react first?

This is a good question – and sounds very reasonable. But within a week or two another 500,000 people will have used the vaccine in the UK.

Any serious concerns will be reported long before you are likely to be offered the vaccine.

However, if you are okay leading a very isolated life, then waiting is a choice. But if you still want to interact with people, then waiting will be more risky than having the vaccine now.

How long will protection last?

This will only be known with more time. Protection should last for at least a year and hopefully a lot longer. Some vaccines, for example hepatitis B and tetanus only need a boost every ten years.

Which vaccine is best?

So far, all the leading vaccines look very good. Getting access to any vaccine now is more important than which vaccine you use.

What if I already had COVID-19? Does it matter where this was severe or mild?

People who already had COVID-19 are still recommended to use the vaccine. It doesn’t matter how severe or mild this was.

Will my GP or HIV doctor give me the vaccine? Can I choose?

Who gives you the vaccine will depend on which vaccine is being used.

The Pfizer vaccine will generally be given at health centres or hospitals. This is because of limits in how it can be stored.

If you are offered a different vaccine in the next month or two, this might be given by your GP. This is early stage for the vaccines but it is unlikely to be your HIV doctor. You are not likely to be able to choose.

Why should I get the vaccine if the person giving me the vaccines hasn’t had it yet?

The decision on who gets the vaccine first are decided by an expert advisory group.

If this group recommends you get the vaccine, then this is because your individual risk makes this important.

Will the vaccine stop me catching COVID-19? Or just from getting ill? Or maybe both?

The vaccine will definitely reduce risk of getting ill, but the answer is “probably both”.

The vaccines are approved because they reduce symptoms of COVID-19.

The first studies didn’t measure whether people caught coronavirus, just whether they had symptoms of COVID-19.

Most mild symptoms later confirmed as COVID-19 were in people who didn’t get the vaccine. Importantly, nearly all the most serious cases of COVID-19 were also in people who got the placebo (inactive) injections.

Technically, some people might still catch coronavirus and be infectious but without symptoms. This is still an ongoing research question.

Studies with the Moderna and Oxford vaccines include some results showing that the risk of catching coronavirus is also reduced.

Is the vaccine safe if I have other health problems as well as HIV?

Yes, vaccines are recommended in people living with HIV and other health problems.

The more serious your other health problems, the more important it will be to be protected from COVID-19.

Can I get the vaccine if I have or have had hepatitis C?

Yes, vaccines are recommended in people living with hepatitis C or who previously had hepC.

Is the vaccine safe if I use chems like crystal meth, GHB or mephedrone?

Yes, the vaccines do not interact with drugs used for chemsex.

However, taking a break from the chems for the week of the vaccine will make it easier to know whether you get any side effects.

If the social context for using chems means you are having more partners, the protection from the vaccine will be especially important.

Is the vaccine affected by ethnicity? Will it affect me differently because I’m black/brown?

No, vaccines studies include people of different ethnicities. They are created for everyone.

Ethnicity does not affect immune responses or risk of side effects.

Are black and brown people more at risk of getting side effects?

No, as with the question above, ethnicity has not been linked to any better or worse outcomes.

Have vaccine trials included black and brown men and women living with HIV? Or do the findings just relate to the experiences of HIV positive white gay men?

Unfortunately, most vaccine studies only included very small numbers of people living with HIV. So far, the ethnicity breakdown of the HIV positive group has not been presented. All the HIV positive participants might be black and brown women.

For example, the Pfizer study with more than 44,000 people only included about 120 people living with HIV. The results did not show that HIV as any impact on how the vaccines work.

However, there is a lot more data about ethnicity.

About 10% of the people in the US sites were black or African American. There were no differences in how well the vaccine worked or in side effects compared to the rest of the study population.

Who approved these vaccines? Were the interests of my community represented?

Vaccine are approved by the same organisations that approve medicines. They were approved for all people.

  • This is the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
  • In Europe it is  the European Medicine Agency (EMA)
  • In the US it is the Food and Drug Administration (FDA).
  • Other countries and regions have similar organisations.

Each of these groups is made up of expert advisors who are mainly scientists and doctors but that sometime include community voices.

The panels are responsible for representing interests of all people who are going to be using these products.

The FDA is especially open as it publishes the detailed study results online for everyone to read. It also webcasts the meeting that decide on where a vaccine or medicine is approved.

How do I know I’m being treated equally? How do I know this isn’t experimentation in black people?

These concerns are very real. Nearly all countries still have structures that are not equal. Many have a history where people were treated differently.

In the UK, this still affects access to important services that include education and medical care. This is even when there are policies to make access fair.

However, ethnicity has been linked to higher risk of COVID-19 in black, Asian and minority ethnic (BAME) communities. This actually makes access to the vaccines even more important.

As all the studies included people from all ethnicities. There is good data to show they are at least as safe and effective.

COVID vaccines will be offered to people of all ethnicities. As has been seen in the news all ethnicities have the choice to use the vaccine.

If the government didn’t protect me from coronavirus, why should I trust them with the vaccine?

Perhaps luckily, the government are not directly involved in either producing the vaccines or in running the studies that look at how well they work.

The government is also not directly involved in deciding which vaccines are approved.

Whether or not you use any medicine or vaccine is a decision that you make with your doctor as an individual.

I’ve experienced racism in the health system and receiving HIV care. How can you tell me this won’t be the same?

I am sorry for any previous experiences within the NHS. I am also sorry if you have not been treated fairly in the past.

Although I can not guarantee this will not happen again, there is a lot of information about how to deal with this.

I can however provide information on COVID-19 and the vaccines. This shows that the benefits of the vaccine so far are much greater than the risks from not getting the vaccine.

Why did we get a COVID-19 vaccine so quickly, but there is still no vaccine for HIV?

There are two answers here.

The practical answer is that the threat from COVID-19 were so serious that many more resources became available. The urgency of COVID-19 led to a larger budget – and luckily, this has been more effective than anyone first hoped.

A more technical scientific answer is coronavirus is relatively stable. Unlike HIV the structure of the proteins doesn’t change and so a vaccine based on these proteins with continue to work.

HIV is still a more difficult virus to overcome because it makes small changes every day. So HIV vaccines that might work very well on Monday will be out-of-date on Friday because of these small changes.

HIV does have at least 30 approved treatments. These enable to lead long and health lives.

There are many other infections where we also need new vaccines. Hopefully the advances for COVID-19 will help for other vaccines.

If vaccines are now available, should I still join a study?

This is an important question because other vaccines are still being studied.

In the UK this includes a vaccine from Oxford University and Astra-Zeneca called ChAdOx1.

Another study is due to start using a vaccine from Janssen.

Joining one of these studies might let you get a vaccine before you are offered on from the NHS.

If you do get offered an NHS vaccine after joining a study, you can still use the approved one. The study will tell you whether or not you got the active vaccine. The researchers can also study your response to the second vaccine.

In practice, new studies will hopefully look at switching between different vaccines.

If the vaccine is lifesaving, why is not available to everyone in the world?

You are right, for a vaccine to be really effective, everyone will need to use it. This includes in all countries.

Many organisations, including the World Health Organization (WHO), have been working all year to also make access fair.

For example, the international COVAX programme is aiming to vaccinate two billion people during 2021. This includes more than 100 low and middle income countries including across Africa, Asia and South America.

So optimistically, at some point, everyone will have access.

In practice, high income countries that could afford the first commercial vaccines have bought most of the first stock.

But some of the next stock during 2021 – and more importantly newer vaccines – will be available for the COVAX programme. This might not be until later in 2021 and 2022 though.

Where can I get more information?

The following links are to different sources for more information.

i-Base run an information service if you have individual questions that you would like answered.

i-Base report news about COVID-19 treatment and vaccines in a monthly bulletin.

British HIV Association (for information about HIV and COVID-19).

UK patient information leaflet for the Pfizer/BioNTech vaccine

FDA 50-page document with detailed results on Pfizer vaccine.

YouTube website to watch the US CDC hearings for COVID vaccines

Article on why vaccine is recommended for people with immune suppression and autoimmune conditions.

Website for WHO COVAX programme for global access.

The People’s Vaccine – a collaboration of large charities including Oxfam.