The Oswaldo Cruz Foundation (Fiocruz) handed over on Friday (8) to the National Health Service (Anvisa) the application for emergency use of the Covid-19 vaccine developed by the AstraZeneca Laboratory and the University of Oxford (see more in the video above). The order is valid for 2 million doses, which must be imported from the Serum laboratory, based in India.
- See Fiocruz production schedule
According to Anvisa, the deadline for the analysis of the emergency request it is ten days. The evaluation of the application for final registration done inside up to 60 days.
Earlier on Friday, Anvisa had already received a request for emergency use of CoronaVac, a vaccine against Covid-19 produced by the Chinese laboratory Sinovac in collaboration with the Butantan Institute. The analysis deadline is the same: ten days.
In mid-December, the organisation’s board of trustees approved the rules for the provisional approval of emergency use of coronavirus vaccines on an experimental basis.
Fiocruz asks Anvisa for urgent use of the Oxford vaccine
Emergency use of vaccines
The main points regarding the urgent use of vaccines are the following:
- each order must be placed by the developing company and will be analyzed independently.
- the decision will be taken by the Anvisa collective council;
- Non-clinical and clinical studies (in humans) will be considered.
- the items evaluated are quality, good manufacturing practices, monitoring and control strategies, and provisional results from clinical trials;
- the company concerned must demonstrate that the manufacture and stability of the product guarantee the quality of the vaccine;
- the clinical trial in phase 3 (the final stage of testing) should be ongoing and also conducted in Brazil;
- the emergency release vaccine cannot be commercialized – it can only be distributed to the public health system;
- and the emergency release can be revoked by Anvisa at any time.
The concession introduced by Anvisa follows the model of emergency permits approved in other countries, such as the United Kingdom, the United States and Canada, and is valid only for the pandemic period and until the immunizer receives the final registration.
Anvisa approved the introduction of vaccines
On Saturday (2), Anvisa approved an order from Fiocruz for the excellent introduction of 2 million doses of the Oxford / AstraZeneca vaccine. The foundation expects to pay Rs 59.4 million for imports.
In the request submitted by Fiocruz, the indication is that the vaccines arrive in the country in January. According to the agency, the introduction is considered excellent because the immune factor has not yet been submitted for emergency approval or health registration.
On October 23, Anvisa approved the introduction of 6 million doses of CoronaVac.
3 ways to register the vaccine
Covid-19 vaccine license in Brazil can be achieved, basically, in three ways.
The the first two are directly linked to the two types of registration that can be granted by Anvisa – traditional or emergency. Me and third possibility based on the call “Lei Covid”, which releases the use if the immunizer has been approved by an outside organization, regardless of Anvisa registration.
See below for details on the three ways to obtain a registration:
- Anvisa – final record: Developers apply to Anvisa only after completing the 3 phases of the vaccine test. To speed up the process, the company created the process of continuous data submission.
- Anvisa – emergency use: allows developers to submit data demonstrating efficacy and safety prior to completion of phase 3 of the vaccine.
- Lei Covid: predicts that Anvisa will have 72 hours to grant a license if the immunizer is registered in Japan, the USA, Europe or China. If the deadline is not met and Anvisa does not respond, the authorization is granted automatically.
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