FDA: Johnson & Johnson’s 1-shot vaccine safe and effective

WHAT YOU NEED TO KNOW:

• A favorable review released by the Food and Drug Administration on Wednesday confirmed that Johnson & Johnson’s vaccine for COVID-19 is safe and very effective against the most severe forms of the disease.
• The document comes two days before FDA’s panel of advisors, the Vaccine and Related Biological Products Advisory Committee (VRBPAC), is set out to vote for the authorization of the vaccine.
• When approved, Johnson & Johnson says they intend to provide 20 million shots by late March with 100 million more over the summer.  

The Food and Drug Administration Wednesday released documents suggesting the Johnson & Johnson’s COVID-19 vaccine is generally safe, and effective in preventing even the most severe diseases.

The favorable safety review comes two days prior a scheduled discussion with the Vaccine and Related Biological Products Advisory Committee (VRBPAC), an independent group of advisors to the FDA, regarding the company’s application for emergency use. Many believe that the VRBPAC will vote to recommend authorization of the vaccine.

Five COVID-19 vaccine makers including Johnson & Johnson told Congress on Tuesday that they’re putting all efforts to accelerate the rollout of vaccine doses in the coming weeks and months.

If and when the FDA will approve their vaccine for emergency use, Johnson & Johnson planned to ship 20 million shots by the end of next month, with an additional 100 million doses over the summer.

In late January, the company announced that the results of its phase 3 clinical trials showed the vaccine candidate’s level of protection against moderate to severe COVID-19 infection was 72% in the United States, which would significantly reduce COVID-19-related hospitalization and death.

The J & J vaccine, made in partnership with Janssen Pharmaceuticals, also demonstrated an 85% efficacy in preventing severe diseases in all geographies studied.

However, the vaccine had shown a 66% lower protection against moderate to severe forms of Covid in a global Phase 3 trial. The drop may be caused by a decrease in the vaccine’s effectiveness against the South African variant, where its efficacy fell to 57 percent.

Furthermore, no reports of death were reported among participants who received the shot, as well as hospitalization, 28 days post-vaccination. Reported side effects included arm pain, headache and fatigue.

The Johnson & Johnson vaccine, which can be stored in normal refrigerator temperatures, is given in a single shot. It uses a weakened common cold virus, called an adenovirus, to carry genetic instructions into the body and prompt the immune system to recognize and fight off SARS-CoV-2, the virus that causes Covid-19.

Whereas, Pfizer and Moderna, both of which require two doses, three to four weeks apart, use genetic technology called messenger RNA, or mRNA technology.

Source: Today