Health experts are anxiously awaiting a one-to-one option to speed up vaccinations, as they fight a virus that is already killing more than 510,000 people in the US and mutating in increasingly worrying ways.
The FDA said that J & J’s vaccine provides strong protection against the most important aspects: serious illnesses, hospitalizations and deaths. One dose was 85% protective against the most serious COVID-19 disease, in a massive study spanning three continents – protection that has remained strong even in countries like South Africa, where the varieties of most concern are spreading.
“This is really good news,” said Dr. Francis Collins, director of the National Institutes of Health, told The Associated Press on Saturday. “The most important thing we can do now is get as many shots in as many arms as we can.”
Shipments of single doses to be divided between states can start as early as Monday. By the end of March, J&J said it was expected to deliver 20 million doses to the US, and 100 million by the summer.
J&J is also seeking permission for the emergency use of the vaccine in Europe and at the World Health Organization. Worldwide, the company aims to produce approximately 1 billion doses worldwide by the end of the year. On Thursday, the island state of Bahrain became the first to use it.
On Sunday, a U.S. advisory committee will meet to recommend how to prioritize the use of the single-dose vaccine. And one big challenge is what the public wants to know: what kind of vaccine is better?
“In this environment, whatever you can get – get,” says dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the benefits of the vaccine outweigh its risks.
The data is diverse on how well all the vaccines are used around the world, leading in some countries to people refusing to wait for another.
In the US, the two doses of Pfizer and Moderna shots were 95% protective against symptomatic COVID-19. The efficiency of J & J from 85% versus severe COVID-19 dropped to 66% when moderate cases were turned in. But there is no apple-to-apple comparison due to the differences in when and where each company conducted its studies, with the Pfizer and Moderna research being completed before variants began to spread.
NIH’s Collins said the evidence of efficacy shows no reason to favor one vaccine over another.
“What people I think most interested in is that it keeps me from getting really sick?” said Collins of NIH. “Will it stop me from dying of this terrible disease? The good news is that all these things say yes to it.”
J&J is also testing two doses of its vaccine in a separate large study. Collins said if a second dose is eventually deemed better, people who received one earlier will be offered another.
The FDA has warned that it is too early to know if anyone who gets a mild or asymptomatic infection despite being vaccinated can still spread the virus.
There are clear benefits besides the convenience of one shot. Local health officials want to use the J&J option in mobile vaccination clinics, shelters for the homeless, even with sailors spending months on fishing boats – communities where it is difficult to be sure that someone will return for a second vaccination in three to four weeks .
The J&J vaccine is also easier to handle and lasts three months in the fridge compared to the Pfizer and Moderna options, which need to be frozen.
“We are very busy getting more stock. This is the limiting factor for us at the moment,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, said, where staff members prepared electronic health records, staff and vaccine storage in anticipation. to offer J&J shots soon.
The FDA said studies did not detect any serious side effects. Like the other COVID-19 vaccines, the main side effects of the J&J shot are injection site pain and flu-like fever, fatigue and headache.
The FDA said there was a “high chance” people could experience a severe allergic reaction to the shot, which is a rare risk with the Pfizer and Moderna vaccinations.
The vaccine has been provisionally approved for emergency use in adults 18 and older. But like other vaccine manufacturers, J&J is about to start a study of the vaccine in teens before moving on to younger children later in the year, and is also planning a study among pregnant women.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by noticing the stimulating protein it covers. But they are made in different ways.
J & J’s shot uses a cold virus like a Trojan horse to carry the pike genes into the body, where cells make harmful copies of the protein to replenish the immune system should the actual virus occur. This is the same technology that the company used to make an Ebola vaccine, and similar to COVID-19 vaccines manufactured by AstraZeneca and the CanSino Biologics in China.
The Pfizer and Moderna vaccines are manufactured using a different technology, a piece of genetic code called messenger RNA that stimulates cells to make those harmless copies.
The AstraZeneca vaccine, which has already been used in Britain and many other countries, is undergoing a major US study that requires FDA approval. Also in the pipeline, Novavax uses an ever-changing technology, made with laboratory-grown copies of the ear protein, and reported preliminary findings from a UK study suggesting strong protection.
Still other countries use ‘inactivated vaccines’, made with killed coronavirus by Chinese companies Sinovac and Sinopharm.
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Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to this report.
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