UK Kicks Off Accelerated Covid-19 Vaccine Review by AstraZeneca and Oxford University | Vaccine

“We confirm the ongoing review of the MHRA [sigla original da agência] of our possible Covid-19 vaccine, “said an AstraZeneca spokesperson.

In this review, regulators can view clinical data in real time and dialogue with pharmaceutical companies on production and testing processes to speed up the approval process. The goal is to expedite evaluations of promising drugs or vaccines during a public health emergency.

When testing a vaccine, usually divided into phases 1, 2 and 3, scientists try to identify serious adverse effects and whether the immunization was able to induce an immune response, that is, a response from the body’s defense system. (read more at the end of this article).

Before testing in humans, vaccines are tested in animals, usually mice and then monkeys.

According to the World Health Organization (WHO), There are currently ten vaccines in the third and final stage of human testing..

On September 8, phase 3 testing of the AstraZeneca vaccine and the University of Oxford had to be temporarily halted. One volunteer experienced adverse reactions, but the studies were resumed four days later.

The continuation of the investigation was released after the Medicines Health Regulatory Authority (MHRA) confirmed that it was safe to continue the investigation.

In Brazil, the vaccine is in phase 3

The British vaccine is considered one of the main bets for immunization against Covid-19 in Brazil. In the country, it is one of the four that are in phase 3 of the tests – this is the last step before it can be released for general use. In the country, the immunizer will be prepared by the Oswaldo Cruz Foundation (Fiocruz).

A Brazilian volunteer who participated in the vaccine tests died of Covid-19; death was revealed on October 21. The volunteer, however, did not receive the vaccine that was being tested, but a placebo (an inactive substance).

The Brazilian government, through the Ministry of Health and Fiocruz, signed a memorandum of understanding with AstraZeneca that provides for the purchase of 30 million doses, with delivery in December of this year and January of next. There is also the possibility of acquiring an additional 70 million if the vaccine has proven efficacy and safety.

In addition, the initial agreement provides for the transfer of technology developed by the University of Oxford and the AstraZeneca laboratory for local production at Fiocruz, with a start date, according to the ministry, still in the first half of 2021.

Before being released to the population, a vaccine must go through three stages of clinical trials that prove its safety and effectiveness. At each stage, more volunteers are recruited, and the researchers review the test results to make sure the immunizer can be licensed.

See below what these three phases are:

• Phase 1 – this is a preliminary evaluation of the safety of the immunizer and involves a small number of healthy adult volunteers, who are closely monitored. It is at that moment that the type of response that the immunizer produces in the body is understood. It applies to dozens of participants.
• Phase 2 – At this stage, the study has hundreds of volunteers. The vaccine is administered to people with characteristics similar to those for which it is intended. In this phase the safety of the vaccine, immunogenicity (or protective capacity), dosage and how it should be administered are evaluated.
• Phase 3– Large-scale trial (with thousands of people) that should provide a definitive evaluation of its efficacy and safety in larger populations. In addition, it prevents adverse events and ensures the durability of the protection. Only after this phase can a medical history be taken.

Phase 1 trials generally involve dozens of volunteers; those of phase 2, hundreds; and phase 3, thousands. These phases are generally carried out separately, but due to the urgency of finding a Covid-19 vaccine, several companies have taken more than one step at the same time.

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