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Pharmaceutical Alliance to Ensure COVID-19 Vaccine Safety

ByCandice Hansen

Sep 5, 2020

Several pharmaceutical companies working on different projects to get a vaccine against COVID-19 plan to sign a joint commitment not to put any preparation on the market without having fully guaranteed that it is safe and effective, regardless of possible political pressure.

As reported this Friday by The Wall Street Journal and The New York Times, the rival companies plan to release a statement early next week in which they promise not to seek the approval of any government until they have made sure that their vaccine is completely safe and effective.

Among the pharmaceutical companies that will sign the document are the American companies Pfizer, Moderna and Johnson & Johnson, the two newspapers agree, while the New York Times adds that the British GlaxoSmithKline (GSK) and the French Sanofi will also share the commitment.

“We believe that this commitment will help ensure public confidence in COVID-19 vaccines that may end up being approved, and in adherence to the rigorous scientific and regulatory process by which they are evaluated,” says the draft of the joint statement, from according to the Journal.

The initiative seeks to appease those who view with skepticism the rapid advance of clinical trials to develop a vaccine, a process that normally takes years, and those who fear that these projects could be accelerated for political reasons, to the detriment of the possible safety or efficacy of the product .

In the United States, the government’s Centers for Disease Control and Prevention (CDC) last week asked all states in the country to be prepared to begin distributing a possible vaccine against the disease in late October or early November. COVID-19, if it is approved.

Those dates, just before the November 3 presidential election, sparked fears among some public health experts that the White House may be pushing to skip steps in the vaccine approval process, in order to boost options for re-election of President Donald Trump.

“It really is possible that (the vaccine) could be distributed before the end of October, and that would be fine. It would be good not because of the elections, but because we want to save people, “Trump said Thursday during a rally in Latrobe (Pennsylvania).

Two of the pharmaceutical companies that will sign the statement, Pfizer and Moderna, have phase 3 trials active in the US and are already inoculating thousands of people to test the effectiveness of their preparation.

Meanwhile, the Johnson & Johnson project is in phase 2, and GSK has two candidates in phase 1, one of them shared with Sanofi, which has another vaccine project in the preclinical stage.

Pfizer CEO Albert Bourla said this week that he hopes his company will have enough data in October to request an authorization for emergency use if the results of its study are positive.

According to the New York Times, senior officials of the US Food and Drug Administration (FDA), on which the approval of a vaccine in this country will depend, are also considering issuing another joint statement to make clear the need to look at science, and not other criteria, when giving the green light to the vaccine.

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