After receiving the approval for the use of the national Active Pharmaceutical Ingredient (IFA) in the manufacture of the vaccine against Covid-19, the Oswaldo Cruz Foundation (Fiocruz) awaits the results of scientific experiments carried out in the United Kingdom to find out if it will be able to use the formula for immunize children and adolescents and also whether the vaccine will have any kind of adaptation to the Ômicron variant of the coronavirus.
So far, developers of the immunizer have not received any negative signs: neither that the vaccine would be ineffective against Ômicron nor that it could not protect children and adolescents.
For now, studies have shown that, given the advance of variants, more doses were needed. For the original genetic formation of the coronavirus, one dose was highly effective. In the delta variant, this same level of effectiveness required a greater amount of response than was given by the second dose. At this time, data indicate that the third dose of the same vaccine produces efficacy against the Ômicron variant. Fiocruz’s vice president for Production and Innovation, Marco Kriger, however, says that this does not mean that an adaptation cannot yield important results.
In Brazil there are already clinical studies with new formulations of the AstraZeneca vaccine – the one produced in Brazil by Fiocruz. It is possible that the answers will come in the near future. Krieger estimates that, if a new formula is more potent, this signal should come in February. In March, therefore, it would already be possible to produce a vaccine adjusted with a national IFA. Until then, clinical, safety and immune response equivalence studies are being conducted with the current formulation and new formats of the vaccine.
children and teenagers
Fiocruz still awaits the response of scientific tests in Oxford to understand the impact of the vaccine on children and adolescents. In an interview with CNN, the president of the foundation, Nísia Trindade, confirmed the expectation. “AstraZeneca in the UK has been conducting clinical trials for the pediatric vaccine so we are awaiting that conclusion. It’s a possibility,” she said.
Thus, the expansion of vaccine delivery to the Ministry of Health is on Fiocruz’s radar if the signal from Europe is positive. Today the commitment is 120 million doses in the first half delivered to the folder.
Krieger claims that the foundation has the capacity to reach 300 million doses delivered in the year 2022. This would mean doubling production, since throughout 2021, 153.2 million doses were sent to the federal government.
Timeline
With the Brazilian API, Fiocruz is no longer dependent on raw material imports. The effective production of the vaccine with national input starts on Monday (10). The pace will be accelerated. Initially 20 million doses will be delivered to the ministry. The factory is prepared to produce one million doses a day.
The process begins with the thawing of the raw material, which was preserved awaiting approval – this takes 3 days. In all, the production and quality control must be carried out in 20 days. This means that the process must be completed in the month of January, so that the first deliveries are made between February 1st and 4th.
Reference: CNN Brasil
