Albuquerque Journal

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.

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