How these vaccines were developed and came to market so fast.

In less than a year since the start of the world wide infectious disease caused by the SARS-cov-2 virus, four different vaccines were approved to reach the public arms. They were all from a brand new technology of vaccines. There are three main reasons why these vaccines candidate from the new technology came to market so fast.

1- The antigen production time is greatly reduced

In order to have a vaccine candidate, the selected antigen must be available for every stages of the process; from R&D to marketing. Usually with the traditional vaccines, the production is carried out in host cells (mammalian cells, chickens eggs) prior to purification to obtain the necessary antigen material for all the stage. The production of the selected antigen (live attenuated virus, protein, etc.) is very time consuming and requires a lot of resources such, money and expertise for production, purification and characterization.

On the other hand, the mRNA or DNA sequence can be easily synthetized and produced in a laboratory setting in large enough quantity. The human body will then be used as producing factory for the antigen, upon injection of the mRNA, providing substantial savings in terms of time, money and resources (for the manufacturers).

2- Overlapping the trials

The clinical trials are the safety net for the public against of any harm that could be caused by drugs or vaccines. Due to the pandemic and the resulting negative impacts, the public felt exhausted and was hungry for a solution. The lingering fear caused strong pressures sending caution to the wind. These vaccine candidates theoretically were very promising. The regulatory agencies authorized breaches on the safety net by allowing the overlapping of the different clinical trials, saving an enormous amount of time in development. In less than six months the vaccine candidates reached marketing, even when for some of them the phase III clinical trials are scheduled to end in 2023.

3- Emergency used authorization

The new generation  of cov vaccines and their technology

Many Covid 19 vaccine candidates are currently part of the global efforts to control the pandemic and are at in different stages of development. So far four of them have received a conditional commercial authorization from different countries. Such approval are granted in specific emergency situation:

  1. Mortal disease
  2. Orphan disease
  3. High risk to public health

U.S. Emergency Use Authorization (EUA) is an option in pandemic response.

After a declaration of emergency by the Department of Health and Human Services secretary, this program allows for use of an unapproved medical product (or a product that has been approved but not for the specific use applicable to the situation at hand) that is the best available treatment or prevention for the threat in question. EUAs were issued for antiviral treatments, a respirator, and a PCR diagnostic test during the 2009 A/H1N1 pandemic.

In the European Union,   EMA’s CHMP may grant a conditional marketing authorization for a medicine if it finds that all of the following criteria are met:

  1. The benefit-risk balance of the medicine is positive;
  2. It is likely that the applicant will be able to provide comprehensive data post-authorization;
  3. The medicine fulfils an unmet medical need;
  4. The benefit of the medicine’s immediate availability to patients is greater than the risk inherent in the fact that additional data are still required.
  5. Conditional marketing authorizations are valid for one year and can be renewed annually.

These approvals come with specific terms and conditions that have to be met in order to maintain and renew the approval. The different authorization letters, from Canada and the European Union can be accessed in the table below.

The vaccine candidates, due to the conditional market authorizations, found their ways into peoples arms , with mere preliminary safety and efficacy results, prior to the completion of the required clinical trials, without IND submission or registration & licensing… In warps speed.

Explore the table below to learn more about each immunization products
CanadaEU
Pfizer-BioNTech Undetermined CAComirnaty
ModernaUndetermined CASpikevax
AstraZenecaUndetermined CAVaxeria
J&JUndetermined CAJanssen
pediatric
Interim orders from Canada and the European Union

Read this forum report analyzing the concept of an EU