Third virus vaccine nears FDA approval

Johnson & Johnson shot safe, review says

WASHINGTON — A third coronavirus vaccine could soon be available in the United States, a one-shot regimen made by pharmaceutical giant Johnson & Johnson that proved safe and effective in a clinical trial and completely protective against hospitalizations and deaths, according to a Food and Drug Administration review released Wednesday.

The document, posted in advance of an all-day meeting of FDA advisers Friday, sets the stage for a vaccine to be authorized as soon as this weekend. As the threat of virus variants continues to swirl, the prospect of another vaccine that could accelerate immunization efforts and prevent more variants from emerging offers hope in the middle of the pandemic.

Public health officials have eagerly awaited the arrival of the Johnson & Johnson vaccine because it is easier to store and administer and could streamline the logistics of a complicated mass vaccination campaign. But supply will continue to limit the nation’s vaccination efforts in the near term, with the full impact of the Johnson & Johnson vaccine not expected until April as manufacturing scales up. If the vaccine is authorized this weekend, federal officials predicted that 3 million to 4 million doses could be allocated next week, with an additional 20 million expected in March.

But the FDA review also hinted that a formidable messaging challenge may lie ahead. After the spectacular and relatively straightforward 90%-plus effectiveness of the first two coronavirus vaccines that were authorized, the Johnson & Johnson results are more nuanced.

Johnson & Johnson’s one-shot vaccine was tested during a more complicated phase of the pandemic, when a variant capable of slipping by some immunity had emerged. It was more than 80% effective at preventing severe illness, including in areas of the world where concerning variants are circulating, but only 66% protective overall when moderate cases were included.