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The urgent approval of an effective vaccine in the treatment of Covid-19 has been one of the main points of contention between the United States Government and pharmaceutical companies, given the pressure from the White House for a vaccine to be available even before the elections of November 3.
The conflict escalated when the Food and Drug Administration submitted the new vaccine approval protocol to the White House Office of Management and Budget on September 21. The document has since been withheld and approval is now considered highly unlikely.
At the heart of the disagreement is a clause recommending that, before granting any authorization, All volunteers participating in clinical trials are followed for two months after receiving the final dose of the vaccine., to control possible side effects. This follow-up period for volunteers leaves any chance that the vaccine will be available before Election Day.
Mark Meadows, the White House chief of staff, voiced a number of concerns about this new report, questioning the need for a two-month follow-up and arguing that these stricter recommendations will change the rules at a time when clinical trials are already underway. on going. The new report also states that the group of volunteers must include at least five cases of severe Covid-19 infection to show that the vaccine is effective not only in preventing mild to moderate illnesses.
Two days after the report was sent for White House approval, US President Donald Trump also raised questions about its approval. “We can approve it or not,” Trump said, after suggesting that the FDA plan is a “political gesture.” Trump has insisted on the promise that a vaccine will be available later this month, despite the fact that no clinical trials in the United States are at an advanced enough stage to guarantee the safety and efficacy of any vaccine. Trump’s goal is to use the vaccine as an electoral asset, given his disadvantage in the polls against his Democratic opponent, Joe Biden.
Subsequently, FDA officials justified their guidelines, explaining that a two-month follow-up is necessary to identify possible side effects and ensure that the protection acquired against Covid-19 is not short-term. However, the justification was not enough to break the deadlock with the White House.
The Food and Drug Administration is now looking at other ways to ensure compliance with the new guidelines, namely by sharing the protocol with an external committee of experts that must meet publicly before the green light is given for emergency use of a vaccine.
The White House undermines security and efficiency efforts
Health experts believe the White House is undermining efforts to ensure that any vaccine for Covid-19 is safe and effective., to the extent that the new FDA protocol sought to ensure that vaccines comply with a common standard and, in this way, transmit confidence to the population.
“The public must have full confidence in the scientific process and the rigor of FDA regulatory oversight if we want to end the pandemic.”, defended the trade association of the biotechnology industry on Thursday, in a letter sent to President Trump’s health secretary, Alex M. Azar II.
Several studies have shown that Americans are increasingly concerned about the Covid-19 vaccine. A survey of Pew Research Center concluded that 51 percent of Americans were willing to accept the vaccine, a drop from 72 percent in May.
For these reasons, Pharmaceutical companies signed a public pledge in early September that they will not rush the approval process for a vaccine, even if that is the intention of the Trump executive.
“In this commitment, all companies say that we will only request authorization to market the vaccine when we have evidence of safety and efficacy from a well-designed three-phase study,” said Albert Bourla, CEO of pharmaceutical company Pfizer, who is in the final stages of testing for a possible vaccine and expect results soon.
Bourla also made it clear that even in the best of scenarios, there will be no vaccination in early November.. “There is a 60 percent chance, in our best case scenario, that we will have a response by the end of October,” announced the Pfizer CEO, noting that this will be “just one response” in terms of safety and effectiveness and does not imply the beginning. vaccination.
This Tuesday, The World Health Organization (WHO) has announced that a vaccine against Covid-19 could be available by the end of the year. “We will need vaccines and there is hope that by the end of this year we can have a vaccine,” said WHO Director General Tedros Adhanom Ghebreyesus, at a time when nine experimental vaccines are already in advanced testing.
