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Tuesday, December 7, 2021
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How much a dose of coronavirus vaccines will cost?

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How is a coronavirus vaccines marketed?

Before being given the green light to be made available to the public, a vaccine goes through a long and rigorous clinical trial procedure. During these tests, it is verified that the vaccine provides the expected protection and that it does not cause major side effects.

The tests are done first in the laboratory on computer models, then on animals and finally on humans, recruiting increasingly large groups of volunteers. We go from a minimum of twenty participants to thousands.

Once the vaccine is judged to be effective and safe, the health authorities grant its producer a “marketing authorization” (MA).

Clinical trials are extended after marketing with continuous monitoring: we always watch for potential side effects, this time across an entire population.

The authorities regularly inspect vaccine manufacturing facilities. These are produced in batches. Producers should test each batch to ensure product purity, potency and safety. Each dose of vaccine delivered must be of the same quality. The lots are identified precisely, to facilitate their traceability.

Vaccines are required to meet excessively strict standards of pharmaceutical quality, efficacy and safety, especially as the general public is greatly concerned about their possible drawbacks.

National and international health authorities are responsible for verifying that vaccines meet these criteria.

The marketing authorization of coronavirus vaccines :

At the end of clinical trials, the vaccine manufacturer must apply for a “marketing authorization” (AMM) from a national or international (European) body. This body decides on the benefit-risk balance of the product. The risk of side effects associated with a vaccine is compared with the expected health benefits of those vaccinated.

At European Union level, the competent body is the European Medicines Agency (EMA). The authorization it issues is valid throughout the European Union.

At European country level: there are so-called decentralized or mutual recognition procedures. A reference Member State gives a favourable assessment to an authorization request, this positive opinion is “recognized” by the other countries.

More and more often, companies that produce vaccines are opting for a European procedure rather than a national one. They must necessarily have obtained a marketing authorization in order to submit a request for reimbursement of their vaccine to the Member States.

Here is how much a dose of the different vaccines against Covid-19 will cost

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