Enough vaccine doses are on their way to inoculate the whole population by the start of summer. Here are answers to some of the most pressing questions, compiled from top health sources by Jessica Arena.

Why should I get vaccinated?

Vaccination is a safe and effective way to prevent disease and save lives. A vaccine trains your immune system to make antibodies without giving you the disease or putting you at risk of its complications.

People who are seriously ill or suffer from certain conditions are sometimes advised not to take certain vaccines, so they rely on the rest of us to do so and help reduce the spread of diseases.

Who made the COVID-19 vaccine?

Several companies are making COVID-19 vaccines. Most of those vaccines are still being tested for efficacy and safety.

A vaccine developed jointly by Pfizer and BioNTech has already gone through testing and has been approved for use by the European Medicines Agency.

Pfizer is an American multinational pharmaceutical company that produces a wide range of medicinal products and vaccines. BioNTech is a German biotechnology company that develops and manufactures immunotherapies to cure specific diseases.

How does the Pfizer/BioNTech vaccine work?

Together, these two companies have developed a new type of vaccine called a messenger RNA vaccine or mRNA.

To trigger an immune response, vaccines typically contain a weakened or inactive form of the virus. The mRNA vaccine does not contain COVID-19. Instead, it contains information that teaches cells how to make a harmless piece of what is called a ‘spike’ protein, something that is found on the surface of the virus that causes COVID-19.

Next, the cell breaks down the spike protein and begins to display it on its surface. This will cause the body to trigger an immune response and begin making antibodies, similar to how it might act if it had been infected with COVID-19.

So the same response is achieved without having to expose a person to the virus.

How has it been tested?

Like any other medicinal product made for humans, the first step in evaluating a vaccine is animal testing.

Animals are given different doses of a vaccine to check for adverse events and an immune response.

Once that stage has been cleared, a vaccine undergoes three phases of clinical trials.

The first is a human pharmacology study (phase one) which involves between 20 to 100 volunteers on whom the behavior of the vaccine is studied. These determine whether the vaccine triggers the expected immune response, if it is safe to move on to a larger study and what doses will be enough.

Phase two is an exploratory study which examines the best doses to use and common side effects. Carried out on a few hundred people, it gives an indication of what a broad response to the vaccine might look like and a good indication of how good it is going to be at prevention.

In phase three, clinical efficacy and safety studies are carried out on thousands of participants. This stage will show how effective the vaccine is at protecting from infection when compared to a placebo. It will also detail what the less common side effects may be.

Is the vaccine safe?

While mRNA vaccines such as that made by Pfizer/BioNTech are new, the technology is not unknown. Scientists have used a variation of the method in research for decades.

The Pfizer-BioNTech vaccine has been proven to be safe in wide (phase 3) clinical trials, with a reported 90% efficacy rate.

The EMA approved the vaccine last week.

The vaccine has also been authorised for use by the UK’s Medicines and Healthcare products Regulatory Agency as well as the Food and Drug Administration in the US.

Who assesses vaccine safety and how do they do it?

To gain vaccine approval in Europe, vaccine makers must submit all their research and testing results to European Medicines Authority.

Assesors at the EMA have been combing through data provided by vaccine manufacturers as it is provided, in what is described as a rolling review process.

A pandemic task force created by the EMA then evaluates the science behind the vaccine and provides a scientific opinion on it.

That opinion is then reviewed by the European Commission, which decides whether to allow EU-wide marketing authorisation of the product.

It is then up to member states to decide on the details of their vaccination policies.

Why did the EU take longer to approve the vaccine?

Regulators in the US and UK have granted the Pfizer/BioNTech an emergency authorisation, meaning the vaccine is essentially unlicenced but permitted for use due to the urgency of the pandemic.

In the EU, regulators have subjected the vaccine to the same review process any other vaccine would be subjected to, only on an accelerated schedule, granting it what is known as a conditional marketing authorisation.

Are manufacturers legally liable if something goes wrong?

Yes. Under the terms of its EU licence, Pfizer/BioNTech are legally responsible for the vaccine they manufacture.

Can everyone take it?

No. Malta’s Superintendent of Public Health has advised children under 16, pregnant women, breastfeeding mothers and women who are planning pregnancy within the next two months not to take the vaccine, as currently there is little data on how these groups have reacted to the vaccine.

Also, a small number of healthcare workers in the UK and US have reported an allergic reaction shortly after taking the vaccine, such as skin rash and difficulty breathing.

Because of this, people who have previously had an allergic reaction to a vaccine have been warned to hold off from taking it until the ingredient causing the allergic reaction is identified.

In Malta, the following people have been advised to consult their doctor first:

  • those who have had severe allergic reactions or breathing problems after any other vaccine injection
  • anyone who has fainted following a needle injection
  • anyone who has a severe illness or infection with high fever
  • anyone with a bleeding problem
  • anyone who uses medicine to prevent blood clots
  • anyone taking medication that might weaken the immune system

This does not apply to people who only experience food or dust allergies. The Pfizer-BioNTech vaccine does not contain eggs, latex or penicillin.

What about the side-effects?

Like any other vaccine or medicine, taking the COVID-19 vaccine can have side effects. After being injected, you may feel discomfort or experience discomfort at the site of injection.

Health authorities say that mild fevers, tiredness and headaches may be experienced after receiving the vaccine.

Can we be confident there won’t be long-term effects?

Like any treatment, there are benefits and risks and no vaccine is 100 per cent effective in preventing disease nor is it 100% safe in all vaccinated people.

Certain rare side-effects may only emerge after millions of people have gotten the jab and time has actually elapsed.

Bodies like the European Medicines Authority continue to monitor vaccine safety while the makers are also required to carry out safety studies.

How long will immunity last?

There is not yet enough information about long-term protection against COVID-19. More research is needed to determine whether or not further booster shots may be necessary in the future.

What’s the risk if I just wait and see?

The longer it takes to vaccinate a population, the harder it gets to choke out the virus.

The World Health Organisation estimates that around 70% of a population must be vaccinated in order to ahieve what is known as ‘herd immunity’ – a situation when so many people are immune to a virus, that it has nowhere to spread to.

New, more contagious strains of the COVID-19 virus, such as that linked to the UK, may mean a higher percentage of a population must be vaccinated to achieve herd immunity, as the more easily a virus is transmitted, the more people must be immune to it for it to stop being spread.

COVID-19 containment measures can only be relaxed once herd immunity has been achieved.

I’m still skeptical. What should I do?

You should talk to your doctor to make the right decision for yourself. Or call the designated vaccine helpline on 145.

You can also call this number if you are given an appointment for vaccination which you do not intend to keep, or if you need to reschedule your appointment for any reason.

Independent journalism costs money. Support Times of Malta for the price of a coffee.

Support Us