Significant disappointment for the American pharmaceutical company
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(NYSE: NVAX) After the Food and Drug Administration (FDA) announced that it needs to test changes in the manufacturing process of the vaccine it has launched to deal with the corona virus. This is after the Advisory Committee on Food and Drug Administration signed the recommendation to approve the vaccine.
Earlier this week (Tuesday), the FDA’s Independent Vaccine Experts Committee voted unanimously on Tuesday in favor of the company’s vaccine recommendation for use in the US, following a meeting in which it reviewed data on vaccine safety and efficacy in preventing coronary heart disease. With the other companies, the director decided to postpone the decision in order to examine the data in depth.
During the epidemic, the FDA acted quickly to approve the corona vaccines after the commission gave its approval. Thus, Pfizer, Moderna and Johnson & Johnson vaccines received FDA approval a day after the commission recommended their use. Which did not happen in the case of NovoWax where the FDA announced that the process might take longer.
In a press release, an FDA spokesman said the company notified the administration of changes in its production process on June 3, just days before the commission was due to review the safety and efficacy data of its vaccine. “The FDA will carefully review this and any additional information submitted by the company as part of its ongoing evaluation and prior to the approval of the vaccine for emergency use,” they said. On the other hand, the company claimed that the updated information they shared with the FDA concerned improvements in its production process, but the biotech company refused to expand beyond that.
The company was one of the many participants in the U.S. government’s vaccine development campaign against Corona in 2020, and even received $ 1.8 billion as part of the effort. Reaching approvals at record speed. While the vaccine is still awaiting approval in the US, the company has begun distributing it worldwide, having been approved in more than 40 countries, including Australia, Canada and the European Union.
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