From side-effects to insufficient clinical data: What those getting Moderna, Pfizer vaccines must know

From side-effects to insufficient clinical data: What those getting Moderna, Pfizer vaccines must know

Fact sheets for recipients of Moderna and Pfizer-BioNTech vaccines in US and UK clarify that the vaccines are yet to be fully approved; recipients have been asked to get help if they experience severe side effects or allergic reactions

Debates continue in India whether the two COVID-19 vaccines that got emergency use authorisation from the country's drug regulator recently are safe and efficacious. Meanwhile, the United States and the United Kingdom, where COVID-19 vaccine rollout for its citizens is underway, have told the vaccines' recipients that those inoculations are not yet ready for a full fledged marketing approval.

The fact sheets for vaccine recipients in US and UK for Moderna and Pfizer-BioNTech vaccines say the vaccines are yet to be fully approved. Moderna's fact sheet for recipients say its vaccine is unapproved and 'may prevent COVID-19'. The UK government says it has only given an approval for 'temporary supply' and not a marketing authorisation for Pfizer vaccine.

US on Moderna COVID-19 vaccine

The Moderna fact sheet tells the recipient about the risks and benefits of the Moderna COVID-19 vaccine, and says it is being administered only due to the pandemic situation. It states upfront that it may not protect everyone.

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"Read this Fact Sheet for information about the Moderna COVID-19 vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19 vaccine" it says.

The fact sheet goes on to disclose that Moderna COVID-19 vaccine is an unapproved vaccine. "In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna COVID-19 Vaccine. In an ongoing clinical trial, the Moderna COVID-19 vaccine has been shown to prevent COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19 is currently unknown," it explains.

The fact sheet lists out a host of possible side effects. It also cautions that these may not be all the possible side effects. "Serious and unexpected side effects may occur. The Moderna COVID-19 vaccine is still being studied in clinical trials," it says.

The fact sheet also states that United States Food and Drug Administration (USFDA) has made the Moderna COVID-19 vaccine available under an emergency access and it has not undergone the same type of review as an FDA approved or cleared product.

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"FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product," it states.

UK on Pfizer COVID-19 vaccine

The information for UK recipients on Pfizer/BioNTech COVID-19 vaccine states that the vaccine "has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency". It clarifies that the vaccine "does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over".

It asks the recipient to talk to the healthcare worker if the person ever had a severe allergic reaction or breathing problems after any other vaccine injection, any severe illness with high fever, or a weakened immune system due to medication or illness. It also cautions that the vaccine may not fully protect all those who receive it and no data are currently available (about the effect of vaccine) in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. The information also lists out over a dozen common side effects.

ALSO READ: COVID-19 vaccine: WHO recommends two doses of Pfizer-BioNTech's jab in 21-28 days

The information leaflet shared with the recipient contains the following:

  • What the vaccine is and what it is used for
  • What you need to know before you receive vaccine
  • How vaccine is given
  • Possible side effects
  • How to store vaccine
  • Contents of the pack and other information

As India proceeds with its vaccination plans for high priority group of population, the debate should be on how to dessiminate more information to the recipients. Perhaps US and UK examples will show the way.