The US has approved Johnson & Johnson’s emergency COVID-19 vaccine and added a third prick to its medical toolbox to tackle one of the world’s worst coronavirus outbreaks.
The Food and Drug Administration (FDA) announced Saturday that Johnson & Johnson’s single-dose vaccine offers strong protection against serious illness, hospitalization and death.
According to a study that spanned three continents, a dose was 85 percent protected from the most serious COVID-19 disease – a protection that remained strong even in countries like South Africa, where one of the most worrisome variants of coronavirus is spreading .
“The approval of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us fight this pandemic that has killed over half a million people in the US,” said the US Regulatory Acting Director Janet Woodcock.
Shipping of a few million cans to be divided among the states could begin as early as Monday.
By the end of March, Johnson & Johnson announced that it would ship 20 million cans to the US and 100 million by the middle of the year.
US President Joe Biden hailed the approval of the third vaccine but warned Americans not to celebrate too early.
“As new varieties spread, it is likely to get worse,” he said in a statement, urging people to keep washing their hands, wearing masks and maintaining social distance.
“There is light at the end of the tunnel, but we cannot let go of our watch now or assume that victory is inevitable,” he said.
“As many shots in as many arms as possible”
In large clinical trials, the effectiveness of the Johnson & Johnson vaccine against serious diseases was 85.9 percent in the US, 81.7 percent in South Africa and 87.6 percent in Brazil. Overall, effectiveness against severe COVID-19 among approximately 44,000 participants in all regions was 85.4 percent, but dropped to 66.1 percent when including moderate forms of the disease.
Crucially, analyzes of different demographic groups did not reveal significant differences between age, race, or people with underlying conditions.
Dr. Francis Collins, director of the National Institutes of Health, described the FDA’s emergency clearance to include Johnson & Johnson as “really good news.”
“The most important thing we can do now is get as many shots in the arms as possible,” he told The Associated Press.
The Johnson & Johnson vaccine is the third to glow green in the US after Pfizer / BioNTech and Moderna received preliminary approvals in December.
The company is also applying for approval for the emergency use of its vaccine in Europe and with the World Health Organization.
More than 65 million people in the US have received at least one shot of Pfizer or Moderna shots to date, both of which require two shots and have an effectiveness rate of approximately 95 percent against all forms of COVID-19 from the classic coronavirus strain.
The two vaccines use the new messenger RNA technology to generate an immune response, and both must be shipped frozen to remain effective.
The Johnson & Johnson one-shot shot involves a more conventional approach. It uses a cold virus to introduce coronavirus proteins into cells to trigger an immune response – the same technology the company used in making an Ebola vaccine and similar to the COVID-19 vaccines made by AstraZeneca in the UK and CanSino Biologics are made in China.
Although the Johnson & Johnson vaccine is slightly less protective than the Pfizer and Moderna vaccine, it remains stable for at least three months at normal refrigerator temperatures, making it easier to vaccinate larger numbers of people, even in areas with poor transportation and storage infrastructure .
Local health officials in the US are trying to use the Johnson & Johnson option in mobile vaccination clinics and homeless shelters, even with seafarers who spend months on fishing vessels – communities where it is difficult to be sure someone in three to four years comes back weeks for a second vaccination.
“We believe that people should be taking the vaccine they can access,” said Acting FDA Commissioner Dr. Janet Woodcock, on a call for approval, stating that the three vaccines had not been studied directly.
“We believe that any of these vaccines will be effective, prevent hospitalizations and deaths, and should be used,” she said.
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