A race that began in March is about to end with the approval of anti-COVID-19 vaccines by the various Regulatory Authorities. Many people, insiders and not, are wondering how it’s possible to arrive at this result so soon, and, what’s more, what the real effectiveness of the vaccines is.

Usually the marketing of a vaccine takes many years, but in the case of anti-COVID-19 vaccines, after only 9 months some pharmaceutical companies have announced the data of Phase III Clinical Trials and then the inevitable marketing.

How was it possible to arrive at the commercialization of an effective vaccine so early?

The answer lies in the exceptional deployment of resources and massive investments made by many governments. The U.S. government launched “Operation Warp Speed” with more than USD $10 billion in funding to develop vaccines, therapies, and diagnostics for SARS-CoV-2. In addition, the new strategy applied was to work in parallel, instead of greatly accelerating vaccine development.

The European Union did not stand idly by, launching the Coronavirus Global Response (CGR) that raised €15.9 billion. As part of the CGR, the European Commission has signed bilateral agreements with several pharmaceutical companies, including AstraZeneca with pre-orders for hundreds of millions of doses of vaccines for use by European citizens.

The United States and other states have funded the research of pharmaceutical companies and have signed pre-order agreements that have guaranteed sales, and have thus reduced the risk of investment by private companies. For example, Moderna received about USD $2.5 billion from the U.S. government; Johnson & Johnson also received a large amount of funding (USD $456 million). Pfizer-BioNTech received no funding from the U.S. but did receive a pre-order worth USD $2 billion.

Is all this acceleration dangerous?

One of the most important (and expensive) issues surrounding the research and production of vaccines is the recruitment and monitoring of Clinical Phase III volunteers.

The funding received has allowed pharmaceutical companies to enroll a huge number of volunteers (from 20,000 to 90,000 — and the number will continue to grow). This means being able to test the efficacy of the vaccine and its possible contraindications on a significant number of people who have been randomly selected, to ensure that everyone is representative in terms of gender, age and ethnicity. Volunteers are divided into two groups: one group is given the vaccine and the other group is given a placebo, and they are followed for a certain period.

People who participate in a Phase III Clinical Trial are left free to live their own lives (within the limits of the safety measures adopted in the places in which they live) and are subject to periodic checks. Of the tens of thousands of volunteers enrolled in the Phase III Trial by Pfizer-BioNTech (43,000) and Moderna Pharmaceutical (30,000), only a fraction have actually contracted the virus. The data released by both pharmaceutical firms say that more than 90% of those vaccinated have not contracted the disease. A very comforting fact that has been confirmed by the recent publication of the Pfizer-BioNTech data in the New England Journal of Medicine!

What is the role of the various regulatory bodies?

Regulatory bodies always have the final say. To name just two: the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) for Europe. Regulatory bodies don’t simply put their stamp on a package but verify the tests carried out and, if necessary, request more information or perform other tests, in order to verify the reliability of the documentation submitted. The FDA on December 11th granted the Emergency Use Authorization for the Pfizer-BioNTech vaccine (EUA: Emergency Use Authorization) which opens the option of administering the anti-COVID-19 vaccine to Americans aged 16 years and older. This authorization follows those already granted for the use of the vaccine in Canada, the United Kingdom, Bahrain, and Mexico.

Let’s clarify the concept of vaccine efficacy

We mentioned that over 90% of people vaccinated with Moderna or Pfizer-BioNTech vaccines have not contracted the COVID-19 disease. The comparison was made with a control group that was given a placebo, and the groups had similar characteristics and were exposed to the risk of infection in the same manner.

However, there are different types of efficacy:

  1. The vaccine prevents infection altogether and is the absolute best efficacy, because it also prevents contagion in addition to the onset of symptoms.
  2. The vaccine prevents the disease and its symptoms (but not necessarily the contagion) and is the status of all vaccines in Clinical Phase III, including those from Moderna and Pfizer-BioNTech.
  3. The vaccine prevents severe forms of infection and therefore hospitalization.

The vaccine’s duration of immunity provides another important parameter still unknown to date. Information that we will receive only by monitoring the levels of neutralizing antibodies present in those subjected to the vaccination. Therefore, as of today (i.e. the date of this post), it’s impossible to say for how long the vaccine will provide protection against infection. It’s realistic to think that we could find ourselves in a situation similar to that of the flu vaccination that must be done every year because of virus mutations.

As we’ve stated, vaccines currently in the final stages of licensing (or down-licensed for emergency use) certainly only prevent disease and symptoms. It is not yet known if they also prevent contagions; that is, if the virus can still replicate in the upper respiratory tract and then be transmitted via a sneeze or saliva. In this case, you should still maintain physical distance, and in situations of “assembly” in any number, continue to wear a mask.

Producing vaccines is not enough

Having an effective vaccine is not enough to vaccinate millions of people in a single nation. This requires very precise and timely logistics; especially knowing how to handle the transport of vaccines at very low temperatures, in the case of the Pfizer-BioNTech vaccine at -80°C.

Millions of special glass vials are needed to ensure vaccine stability, as well as special syringes. This is a new challenge that will engage not only pharmaceutical companies but also hospitals, pharmacies and all health-care professionals involved.

Finally, let’s not forget that we’ll need a vaccination plan that clearly states who to vaccinate first and who comes later. These are important decisions to be made, based on epidemiological information and the properties of the vaccines that will be available.

This post is also available in: Italiano


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