The United States has cleared Johnson & Johnson’s COVID-19 vaccine for emergency use, adding a third blow to its medical toolbox to tackle one of the world’s worst coronavirus outbreaks.
The Food and Drug Administration (FDA) said on Saturday that Johnson & Johnson’s single-dose vaccine offered strong protection against serious illness, hospitalization and death.
One dose protected 85% against the most serious COVID-19 disease, according to a study that spanned three continents – protection that has remained strong even in countries such as South Africa, where one of the coronavirus variants the most worrying is spreading.
“The authorization of this vaccine expands the availability of vaccines, the best method of medical prevention of COVID-19, to help us in the fight against this pandemic, which has claimed more than half a million lives in the United States », Declared the American regulator. Acting Director Janet Woodcock.
Shipments of a few million doses to be distributed among the states could begin as early as Monday.
At the end of March, Johnson & Johnson said it planned to deliver 20 million doses to the United States and 100 million by the middle of the year.
US President Joe Biden hailed the authorization of the third vaccine, but warned Americans against celebrating too soon.
“Things are likely to get even worse as new variants spread,” he said in a statement, urging people to continue to wash their hands, wear masks and maintain their social distances .
“There is light at the end of the tunnel, but we cannot let our guard down now or assume victory is inevitable,” he said.
“ As many hits in as many arms as possible ”
In large clinical trials, the effectiveness of the Johnson & Johnson vaccine against serious illness was 85.9% in the United States, 81.7% in South Africa and 87.6% in Brazil. Overall, among about 44,000 participants in all regions, the efficacy against severe COVID-19 was 85.4%, but it fell to 66.1% including moderate forms of the disease.
Importantly, analyzes of various demographic groups found no marked differences by age, race, or people with underlying illnesses.
Dr Francis Collins, director of the National Institutes of Health, called the emergency FDA approval for the Johnson & Johnson coup “very good news.”
“The most important thing we can do right now is get as many shots in as many arms as possible,” he told the Associated Press news agency.
The Johnson & Johnson vaccine is the third to be enlightened in the United States following provisional approval from Pfizer / BioNTech and Moderna in December.
The company is also seeking authorization for emergency use of its vaccine in Europe and from the World Health Organization.
More than 65 million people in the United States have so far received at least one hit from the Pfizer or Moderna jabs, both of which require injections and are approximately 95% effective against all forms of COVID -19 of the classical coronavirus strain.
Both vaccines use new messenger RNA technology to create an immune response, and both must be shipped frozen to remain effective.
Johnson & Johnson’s unique shot involves a more conventional approach. It uses a common cold virus to introduce coronavirus proteins into cells to trigger an immune response – the same technology the company used to make an Ebola vaccine, and similar to the COVID-19 vaccines made by AstraZeneca in the Kingdom -Uni and CanSino Biologics in China.
Although slightly less protective than the Pfizer and Moderna vaccine, the Johnson & Johnson vaccine remains stable for at least three months at normal refrigerator temperatures, making it easier to vaccinate more people, even in areas where transport and storage infrastructure are poor.
Local health officials in the United States are looking to use the Johnson & Johnson option in mobile vaccination clinics, homeless shelters, even with sailors spending months on fishing boats – communities where it is difficult to be sure that someone will come back in three to four weeks for a second vaccination.
“We believe people should take the vaccine they have access to,” Acting FDA Commissioner Dr. Janet Woodcock said in a post-clearance appeal, noting that the three vaccines had not been studied face to face.
“We believe that each of these vaccines will be effective, prevent hospitalization, death and should be used,” she said.