FDA approval expected soon for J&J's COVID-19 vaccine

White House plans to send up to 4 million doses of the third COVID-19 vaccine shortly

The Biden administration is planning to send states, pharmacies and community health centers 3 million to 4 million doses of Johnson & Johnson’s coronavirus vaccine as early as next week, as the vaccine is expected to be approved by the Food and Drug Administration.

The FDA on Wednesday released documents showing the one-shot vaccine to be effective and safe, and regulators said there were no identified safety issues that would prevent an emergency OK.

J&J said its vaccine showed 86 percent efficacy against severe forms of COVID-19 in the US, and 82 percent against severe disease in South Africa, where a highly contagious variant emerged in the fall and is now driving most cases.

The J&J vaccine is the first vaccine to show efficacy given as a single dose. It also doesn’t need to be kept frozen when being shipped, as do the vaccines developed by Moderna and the team of Pfizer and BioNTech. Both of those advantages could have a big impact when it comes to vaccinating as many people as possible to slow the spread of the novel coronavirus.

On Friday, the FDA will convene a panel of independent experts to debate and vote on whether to recommend J&J’s vaccine for regulatory approval. Experts expect the committee to approve the shot in the following days.

White House COVID-19 response coordinator Jeff Zients told reporters Wednesday that if the vaccine is authorized by the FDA, “we are ready to roll out this vaccine without delay.”

The 3 million to 4 million number is an increase over what officials told governors on Tuesday, and likely reflects that J&J told Congress it will have 4 million doses ready to ship immediately upon authorization.

The pharmaceutical company said it aims to deliver a total of 20 million doses by the end of March, and 100 million doses by the end of June.

Zients said the administration is working with the company to “accelerate the pace and time frame” for the full 100 million doses. The US government agreed in August to pay $1 billion for those doses, and the healthcare giant has pledged not to sell doses for a profit during the pandemic.

J&J has said it will have nearly 4 million doses ready to ship upon emergency authorization and is on track to deliver 100 million doses to the US by the end of June.

Moderna is set to launch a clinical trial of a new vaccine designed to combat a variant of the virus, the company announced Wednesday. Moderna said it has produced enough of its variant-specific candidate vaccine, called mRNA1273.351, to begin testing it in people.

Moderna said that “out of an abundance of caution”, it has begun pursuing two possible strategies against the variant: giving people a booster dose of the original vaccine to increase antibody levels, and developing two variant-specific vaccines, which could be given instead of the original one.

It will test several variations of a booster, the company said, including a single, low-dose shot of the variant-specific vaccine; a shot that includes both the original vaccine and the variant-specific one; and a third low-dose version of the original vaccine.

In a study published last week, Moderna showed that blood from people who received the current vaccine includes neutralizing antibodies against the major known variants. But only one-sixth of their antibodies were protective against the B.1.351 variant of the virus, which originated in South Africa, and which is the target of its new vaccine.

Any change to address variants, which other vaccine makers also are working on, would need to be approved by the FDA.