The Food and Drug Administration released new guidelines on Tuesday for coronavirus vaccine developers — a step that had been held up for two weeks by top White House officials. The guidelines make it highly unlikely that a vaccine could be authorized by Election Day.

The move, which was cleared by the White House’s Office of Management and Budget, appeared to be an abrupt reversal a day after The New York Times reported that White House officials, including Mark Meadows, the chief of staff, were blocking the guidelines. Top F.D.A. officials were caught by surprise when they learned midafternoon that the new guidelines had been cleared.

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The vaccine maker Novavax said Thursday that it would begin the final stages of testing its coronavirus vaccine in the United Kingdom and that another large trial was scheduled to begin next month in the United States.

It is the fifth late-stage trial from a company supported by Operation Warp Speed, the federal effort to speed a coronavirus vaccine to market, and one of 11 worldwide to reach this pivotal stage. Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials.

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The feverish race for a coronavirus vaccine got an infusion of energy on Wednesday as Johnson & Johnson announced that it has begun the final stage of its clinical trials, the fourth company to do so in the United States as the country hits a grim milestone of 200,000 deaths from the pandemic.

Johnson & Johnson is a couple of months behind the leaders, but its advanced vaccine trial will be by far the largest, enrolling 60,000 participants. The company said it could know by the end of this year if its vaccine works.

Continue reading “Johnson & Johnson’s Vaccine Advances, Sparking Optimism in Race” →

The pharmaceutical company AstraZeneca said Saturday that it had resumed its coronavirus vaccine trial in Britain after suspending it six days ago over potential safety issues but that its trials in the United States and other countries were still on hold.

The news came the same day that a competitor, Pfizer, said it was expanding the trial of its coronavirus vaccine to 44,000 people — a big increase from its previous goal of 30,000 — in an effort to recruit a more diverse group of participants and potentially cut down the time needed to get results from the trial.

Continue reading “AstraZeneca Partly Resumes Coronavirus Vaccine Trial After Halting It for Safety” →