New FDA Rules Could Seriously Delay COVID-19 Vaccine

( After President Donald Trump’s “Operation Warp Speed” gave medical experts and scientists the ability to go about producing a COVID-19 vaccine without being slowed down by unnecessary red tape, new regulations from the Food and Drug Administration (FDA) could slow the process down at the last hurdle.

A new regulation, now accepted by the White House, will delay the production and delivery of the vaccine. It means that, unlike originally expected, the vaccine may not be approved before the election.

According to the Wall Street Journal, the White House has “case aside” its objections to the plans put forward by the FDA to assess whether the vaccine should be given to the public. Trump’s administration has endorsed the new regulations, meaning that the vaccine will likely only be available at the end of the year or into the next year.

A senior administration official said that the White House was holding the guidelines for review, and after weeks of expressing opposition to the plan, has conceded. The regulations will involve a two-month observation period to see if people who receive the shot suffer negative effects, despite evidence already showing the vaccines to be safe.

After receiving approval from the White House, the FDA published the new plans on its website on Tuesday. The rules explain how drug makers will need to take part in trials that last at least two months.

It’s a blow to President Trump, who has so far successfully overseen the production and testing of a vaccine in a way that was not rushed but was not plagued with red tape that slowed the process down. FDA Commissioner Stephen Hahn even said just last month that he believed the FDA could give the green light to a vaccine after it has completed the final phase of clinical trials, which are nearly over.

Trump also said that the FDA plan “sounds like a political move,” and told the press last month that he “may or may not approve” the guidelines.

The Associated Press reported that a senior official from the Trump administration said that while the White House has endorsed the decision, they believed there was “no clinical or medical reason for the additional hurdle.”

No doubt Kamala Harris, the Democratic VP candidate who recklessly said that she would not support a vaccine developed under Trump’s administration, will be jumping for joy at the news.