The Food and Drug Administration approved a Johnson & Johnson shot that works with only one dose instead of two to prevent COVID-19 in the United States on Saturday.
As they race against a virus that has already killed over 510,000 people in the United States and is mutating in increasingly alarming ways, health experts are eagerly awaiting a one-and-done solution to help accelerate vaccinations.
According to the FDA, J&J’s vaccine provides good protection against the most serious infections, hospitalizations, and death. In a wide study spanning three continents, one dose was found to be 85 percent protective against the most serious COVID-19 illness — safety that remained high even in countries like South Africa, where the most troubling variants are spreading.
Dr. Francis Collins, director of the National Institutes of Health, told The Associated Press on Saturday, “This is very good news.” “Right now, the most important thing we can do is get as many shots into as many guns as possible.”
J&J would initially have a few million doses, with shipments to states starting as soon as Monday. J&J has announced that it plans to supply 20 million doses to the United States by the end of March, and 100 million by the summer.
J&J is also seeking approval from the World Health Organization and the European Commission for the emergency use of its vaccine. By the end of the year, the company expects to have produced around 1 billion doses worldwide. Bahrain, an island nation, was the first to accept its use on Thursday.
President Joe Biden said in a statement, “This is exciting news for all Americans and a promising step in our efforts to end the crisis.” “But let me be clear: this war is far from over,” he said, urging people to continue wearing masks and taking other public-health precautions.
A US advisory committee will meet on Sunday to make recommendations on how to prioritize the use of the single-dose vaccine. One major obstacle is the public’s need to know which form is superior.
Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the vaccine’s benefits outweigh its risks, said, “In this setting, whatever you can get, get.”
Data about how well all of the vaccines currently in use around the world perform is mixed, causing reports in some countries of people refusing to wait for one vaccine in favor of another.
The two-dose Pfizer and Moderna shots were 95 percent successful against symptomatic COVID-19 in the United States. When mild cases were introduced, J&J’s one-dose efficacy of 85 percent against extreme COVID-19 fell to 66 percent. However, there is no apples-to-apples comparison due to variations in when and where each company performed its studies, with Pfizer and Moderna’s studies completed before the spread of variants.
Collins of the National Institutes of Health claimed that there is no reason to choose one vaccine over another based on the facts.
“I guess the biggest question is whether or not it would protect me from being severely ill.” Collins expressed his view. “Will it prevent me from succumbing to this awful disease?” The good news is that they all say yes.”
In a separate broad trial, J&J is testing two doses of its vaccine. People who received the first dose will be given a second if a second dose were later found to be better, according to Collins.
It’s too early to say whether anyone who gets a mild or asymptomatic infection after vaccination can still spread the virus, according to the FDA.
Aside from the ease of a single shot, there are some distinct advantages. Local health authorities are considering using the J&J option in mobile vaccine clinics, homeless shelters, and even with sailors who spend months at a time on fishing vessels — areas where it’s impossible to predict if anyone would return in three to four weeks for a second vaccination.
In contrast to the Pfizer and Moderna vaccines, which must be frozen, the J&J vaccine is much simpler to treat, lasting three months in the refrigerator.
“We’re salivating at the thought of having more supply. “Right now, it is our limiting factor,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staffers were planning electronic health records, staffing, and vaccine storage in anticipation of soon providing J&J shots.
According to the FDA, no significant side effects were discovered in trials. The major side effects of the J&J shot, like other COVID-19 vaccines, are injection site discomfort, flu-like fever, weakness, and headache.
According to an FDA fact sheet for vaccine users, there is a “small risk” that people may have a serious allergic reaction to the injection, as has occurred in the past with Pfizer and Moderna vaccines. Such reactions are treatable, and vaccine recipients should be monitored for a limited period after receiving the injection.
For the time being, the vaccine has been approved for emergency use in adults 18 and older. However, J&J, like other manufacturers, is planning to explore how it works in adults before moving on to younger children later this year, as well as a study in pregnant women.
COVID-19 vaccines all teach the body to identify the new coronavirus by detecting the spikey protein that coats it. However, they are formed in very different ways.
J&J’s vaccine uses a cold virus as a Trojan horse to bring the spike gene into the body, where cells create harmless copies of the protein to brace the immune system for when the real virus arrives. It’s the same technology the company used to produce an Ebola vaccine, and it’s close to AstraZeneca’s COVID-19 vaccine and CanSino Biologics’ COVID-19 vaccine.
The mechanism of action of J&J’s vaccine
The Pfizer and Moderna vaccines use a different technology, a piece of genetic code known as messenger RNA, which encourages cells to generate those harmless spike copies.
The AstraZeneca vaccine, which is already in use in the United Kingdom and a number of other countries, is approaching the end of a major FDA-required study in the United States. Novavax, which uses a different technology based on lab-grown copies of the spike protein and has published preliminary results from a British study indicating good safety, is also in the works.
Some countries are using Sinovac and Sinopharm’s “inactivated vaccines,” which are made with killed coronavirus.