The first one-shot vaccine COVID-19 offers good protection against the disease, Johnson & Johnson reported in an important study released on Friday, offering the world a potentially new tool as it runs to stay ahead of the rapidly changing virus .
The pharmaceutical giant’s preliminary findings suggest that the single-dose option may not be as strong as the two-dose formula from Pfizer or Moderna and was markedly weaker against a worrying mutant version of the virus in South Africa.
But in the midst of a difficult start to vaccinations worldwide, this may be an acceptable trade-off for more people to be inoculated more quickly with an easier-to-handle injection that, unlike rival vaccines that must be kept frozen, can last for months in the refrigerator.
“Frankly, the simple is beautiful,” said Dr. Matt Hepburn, leader of the US government’s response to the COVID-19 vaccine.
J&J plans to seek authorization for emergency use in the U.S. within a week. It hopes to supply the United States with 100 million doses by June – and one billion doses globally by the end of the year – but it did not say how much could be ready if the Food and Drug Administration gives the green light.
Defeating the scourge that killed more than 2 million people worldwide will require the vaccination of billions. Vaccines that have been launched in different countries so far require two doses a few weeks apart for full protection. Nearly 23 million Americans have received the first dose of injections from Pfizer or Moderna since the vaccines began last month, but less than 5 million have received the second dose.
Also on Friday, regulators released a third option, the AstraZeneca vaccine, for use across the European Union. The decision was made amid criticism that the 27-nation bloc is not moving fast enough, as well as concerns that there is not enough data to say how well the vaccine works in older people.
J&J studied its single dose option in 44,000 people in the United States, Latin America and South Africa. Interim results showed that the injection was 66% effective overall in preventing moderate to severe COVID-19 and much more protective – 85 % – against the most serious symptoms. There were no serious side effects.
“Playing with a shot was certainly worth it,” said Dr. Mathai Mammen, head of global research at J&J Pharmaceuticals, J&J, to the Associated Press.
The vaccine worked best in the US – 72% effective against moderate to severe COVID-19 – compared to 66% in Latin America and 57% in South Africa, where a more contagious mutant virus is spreading.
The reduced protection against this mutation is “really a wake-up call,” said Dr. Anthony Fauci, the United States’ leading infectious disease specialist.
The more the virus can spread, the more opportunities it has to mutate. Vaccine manufacturers are studying how to change their vaccines, if necessary.
For now, the findings are an incentive “to vaccinate as many people as we can,” emphasized Fauci.
The data is mixed on how well other vaccines being used around the world work, but Pfizer and Moderna injections were 95% protective in large studies in the United States.
It is not fair to compare studies done before the record increase in recent months and the discovery of new mutants – they may not be the same today, warned Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
J&J’s protection is “good enough to help attack a pandemic,” said Goodman. “The advantage of having more vaccine, in a single injection, would be significant.”
The researchers tracked illnesses from 28 days after vaccination – around the time when, if participants were receiving a range of two doses, they would need another injection.
After the 28th, no one who was vaccinated needed hospitalization or died, regardless of having been exposed to the original virus or “those particularly unpleasant variants,” said Mammen. When the vaccinees were infected, they had a milder illness.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by detecting the spiny protein that surrounds it. But they are done in very different ways.
The J&J injection uses a cold virus like a Trojan horse to carry the spike gene to the body, where cells make harmless copies of the protein to prepare the immune system in case the real virus appears. It is the same technology that the company used to make a successful Ebola vaccine.
It is similar to how the two-dose AstraZeneca vaccine is made, although it is not exactly how well this vaccine works. Tests in Britain, South Africa and Brazil have suggested that two doses are about 70% effective. A study in progress in the USA may provide more information.
Yet another vaccine is in final testing: Novavax reported this week that their vaccine appears 89% effective in a British study and that it also appears to work – albeit not so well – against new mutant versions of the virus circulating in Britain and South Africa. A larger study in the US and Mexico is still recruiting volunteers.
Wall Street seemed dissatisfied with J&J’s results, with shares falling 4.2% at the start of the trading day, a rare big drop for the world’s largest manufacturer of healthcare products. Its shares fell $ 4.07, or 2.4%, to $ 165.09 in mid-morning trading.
In contrast, minuscule Novavax saw its stocks soar, jumping 71%, to $ 229.72 on mid-morning trading.
___
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.