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EMA and FDA: Covid Vaccine is cleared but not approved. What is the difference?

The FDA has authorised the distribution of the vaccines created by Pfizer Inc. and BioNTech in the United States, but has not approved them.

“There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.”

All drugs administered and marketed in a particular country are pre-approved by the local regulator. In this particular case, none of the Covid-19 vaccines have been approved by the FDA, only authorized. What is the difference?

During a pandemic the rules can take on new contours due to the concept of Emergency Use Authorisation – their use is authorised quickly if it is “determined that a public health emergency with the potential to significantly affect the health and safety of citizens exists” and under a number of criteria, including:

  • Based on the totality of the available scientific evidence, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective in preventing, diagnosing or treating such a serious or life-threatening disease or condition that could be caused by SARS-CoV-2.
  • The known and potential benefits of the product outweigh the known and potential risks.
  • There is no suitable alternative to the product, approved and available, for the diagnosis, prevention or treatment of the disease or condition.

The FDA, Centers for Disease Control and Prevention, and other government agencies are responsible for safety oversight. If they determine that the benefits of the vaccine no longer outweigh the harms, emergency use authorization may be revoked.

The US agency uses an alternative assessment process specifically designed to speed up the FDA’s usual approval process. Still, this green light implies several rounds of clinical trials – 3 in the case of the US and Europe – and subsequent approval by internal and independent teams of doctors and scientists.

In Europe

This scenario is repeated on the old continent. In Europe, the European Medicines Agency explains that Pfizer’s vaccine has been granted conditional marketing authorisation.

“This medicine has been granted a conditional marketing authorisation. This has been granted in the interests of public health because the medicine responds to an unmet medical need and the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.”

In the EU, a conditional marketing authorisation is different from an emergency use authorisation. In the latter, “the temporary use of a product is allowed under specific conditions, provided that there are emergency circumstances. However, the medicine does not obtain an authorisation and cannot be placed on the market, unlike in the (conditional) marketing authorisation“.

Like the FDA, the EMA confirms that “the EMA’s Committee for Human Medicinal Products (CHMP) has conducted a rigorous assessment of Comirnaty (the name of the 1st vaccine), and concluded by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation“, and assures that surveillance will be maintained.

The safety and efficacy of the vaccine will continue to be monitored as it is used in Member States, through the EU pharmacovigilance system and additional studies conducted by the company and European authorities.

Pfizer-Biotech’s own website reports that:

“The approval status of the Pfizer-BioNTech Covid-19 vaccine varies worldwide. In countries where the vaccine has not been approved by the relevant regulatory authority, it is an investigational drug, and its safety and efficacy have not been established.”

Why were they not approved?

For a vaccine to be approved, manufacturers must “continue to collect placebo-controlled data in trials for as long as feasible” before they can apply for regular approval.

Companies applying for approval of a vaccine in the EU must ensure that clinical studies meet the strict EU requirements, regardless of where in the world they took place,” says the EMA.

Full approval comes when the vaccine meets all safety and efficacy standards, and is no longer experimental. There is still a lot of unknown information, such as the effect on specific groups like children (up to 16 years old), pregnant women, people with other associated diseases (HIV, Hepatitis B and C, autoimmune diseases, …), among other examples. Although there are several tests and studies in progress, the available information is still limited or not known.

For example, information on the effectiveness in immunocompromised people (people with a weakened immune system) is still limited, but the vaccine is not advised against. In the case of children, the NHS explains that:

“Clinical trials with children are still scarce and it is not yet possible to say whether the vaccine is safe and effective, or what dose should be given to this group. Children can trigger a natural, rapid and effective response against the virus, and this disease is less severe in children.”

Besides the EU, Japan, Canada and Australia are also running their regulatory processes for fast track approval.

And if something goes wrong whose responsibility is it?

Under the terms of an emergency clearance, companies like Pfizer or Moderna are exempt from social liability if something goes wrong with vaccines. In the US, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act, a law that grants legal protection to companies that make or distribute critical medical products, such as vaccines and treatments, barring “willful misconduct” on the part of the company. The protection lasts until 2024.

This means that for the next four years, these companies “cannot be sued for monetary damages in court” for injuries related to the administration or use of products to treat or protect against Covid. This immunity also extends to the FDA, for distribution authorization, and to employers who mandate vaccination as a condition of employment.

In Europe, in August, a memo from Vaccines Europe cited by the Finantial Times called for a “comprehensive blame-free, non-compensatory compensation system” and a “civil liability exemption” for problems that may arise and that are “unavoidable due to the speed and scale of development and implementation” of an eventual covid-19 vaccine.

The speed and scale of development and implementation mean that it is impossible to generate the same amount of underlying evidence that would normally be available through extensive clinical trials and the experience built up by healthcare providers building experience,” the memo says.

When the UK government placed the BioNTech/Pfizer vaccine on the market, it granted the company statutory civil damages to protect the company (and healthcare professionals) from civil claims for damages related to any unforeseen complications arising from the administration of the vaccine.

Europe has granted a conditional marketing authorisation, not emergency use authorisation as issued by other countries.

“A conditional marketing authorisation respects a controlled and robust framework that provides guarantees that emergency use authorisations may not provide. In reality, an emergency use authorisation is not an authorisation of the vaccine but an authorisation for temporary use of the unauthorised vaccine.”

This difference is visible in the legal field. Under an EU conditional marketing authorisation, the responsibility lies with the marketing authorisation holder, who will be responsible for the medicine and its safe use.

“A conditional marketing authorisation shall be valid for a period of one year, renewable, and shall entail for the holder the same rights and responsibilities which apply to a normal marketing authorisation. In addition, the holder of a conditional marketing authorisation has specific obligations, such as completing or conducting new studies within a defined period of time in order to confirm that the benefit/risk balance remains positive.”

In the case of an emergency use authorisation to temporarily authorise the distribution of an unauthorised medicinal product (Article 5(2) of Directive 2001/83), EU law requires Member States to remove administrative and civil liability from the manufacturer and the marketing authorisation holder where such emergency use is recommended or required by the Member State.

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