Johnson & Johnson COVID-19 vaccine, which requires just one shot, is on track to become third allowed for use in US
A government advisory board is likely to give a third COVID-19 vaccine a thumbs up on Friday, paving the way for increased supply of the coveted vaccines.
Drug maker Johnson & Johnson's new vaccine offers several advantages over the two that have been given to 45 million Americans since mid-December, although it may be a little less effective.
The J&J vaccine only requires one shot. The others from Pfizer-BioNTech and Moderna need two. It can be kept refrigerated longer than frozen, making it easier to distribute across doctor's offices and rural outposts. And it can cause fewer side effects.
The advisory panel, known as the Advisory Committee on Vaccines and Related Biological Products, is expected to recommend the shot for use in adults at the end of a full-day meeting. Emergency approval from the acting representative of the Food and Drug Administration is expected to follow within a few days.
Most people will not have a say in what vaccine they will receive. Allocation decisions are made by individual states, which generally have only provided one type of vaccine to each vaccination center.
Public health officials say it doesn't matter what vaccine someone gets.
A third vaccine is "nothing but good news," America's best infectious disease doctor Anthony Fauci told NBC's "Today" show early Thursday. "Having two is fine. Having three is absolutely better."
This December 2, 2020 photo by Johnson & Johnson shows vials containing the COVID-19 vaccine from Janssen in the United States.
Johnson & Johnson said it will provide 20 million doses of the vaccine in March and another 80 million by the end of June to meet a contractual agreement with the government. Taxpayers paid nearly $ 500 million to develop the vaccine and $ 1 billion to make and dispense those 100 million doses.
The government prepaid the vaccines, and the insurance companies or the government will likely cover the cost of administering shots so no one has to pay out of pocket for protection.
With new variants floating around that could affect the effectiveness of vaccines, it is important, according to Fauci and others, to get as many people as possible vaccinated as soon as possible to reduce transmission before more dangerous viral variants can spread or develop.
Moderna and Pfizer-BioNTech vaccines were shown to be more than 94% effective in large clinical trials last fall. This has been confirmed by a real study in Israel.
The J&J vaccine was found to be 72% effective in its large study in the US, but less effective in South Africa and Latin America, where variants were in circulation.
Some people will be more comfortable with the J&J vaccine because it is based on technology with a longer track record or just requires one dreaded shot. others will oppose a vaccine that may be less effective - but they shouldn't, public health experts told USA TODAY.
All COVID-19 vaccines have been shown to prevent serious illness and death.
"People should get vaccinated with any vaccine they can get from FDA-cleared vaccines," said Dr. Jesse Goodman, Professor of Medicine and Infectious Diseases at Georgetown University Medical Center.
The J&J vaccine is more effective than the annual flu shot and will help contain the pandemic, said Dr. Eric Schneider, senior vice president of policy and research for the Commonwealth Fund, a private philanthropy dedicated to health policy and practice.
"Anything that slows down transmission even for part of the population will be a great addition," said Schneider.
The less restrictive storage requirements will allow the J&J vaccine to be distributed from primary care doctor's offices, although it's not clear whether those offices were able to get vaccinations after the disastrous year they financially had in 2020 when the patients did stayed away and the bills essentially fell.
The fact that Moderna and Pfizer-BioNTech's vaccines are "historically effective" should not detract from the somewhat inferior, but still excellent, effectiveness of the J&J vaccine.
"If we didn't have Moderna and Pfizer already at 95% effectiveness, we'd be jumping up and down with J&J," said Dr. Thomas Balcezak, clinical director of Yale New Haven Health. "Somehow, now that we have a 95% effective vaccine, we've cooled this vaccine that we would have liked a year ago."
J&J uses different vaccine technologies
All vaccines are equally effective where it matters, said Anna Legreid Dopp, senior director of clinical guidelines and quality improvement for the American Society of Health System Pharmacists.
"They reduce symptomatic serious illnesses that lead to hospitalization and death," she said. "It is these two things that reduce the overall burden on society and the burden on our health system as a whole."
She said pharmacists will be ready to deal with any vaccine, but J & J's is based on technology that pharmacists have used, so they are likely to be more familiar with it than the Pfizer-BioNTech and Moderna vaccines.
The first two vaccines are based on what is known as mRNA technology and, with similar safety and efficacy profiles, are practically indistinguishable. They use the body's own natural protein manufacturing system to instruct the cells to make the spike protein on the outside of the SARS-CoV-2 virus particles.
As soon as the immune system has learned to recognize this spike protein, it attacks when infected with SARS-CoV-2.
Los Angeles health workers administer COVID-19 vaccinations on Feb.24.
The J&J vaccine instead uses a harmless virus called adenovirus 26 to deliver the spike protein to cells and train the immune system.
No one in the study had an allergic reaction severe enough to require adrenaline, although one man endured extensive hives and discomfort.
Although all of the vaccines seem very safe, the side effects of the J&J vaccine appeared to be milder and less common than the other two, said Dr. Colleen Kraft, associate chief medical officer of Emory University Hospital, in a call with reporters Thursday.
"The J&J vaccine is believed to be a little less reactive or stimulatory to the immune system, which may be related to protection," she said.
Pfizer-BioNTech and Moderna vaccines have caused serious allergic reactions in two to six vaccine recipients per million doses dispensed. These reactions occurred when the vaccines were being given to millions of people, not during their large clinical trials.
All vaccines can cause aching arms, muscle aches, headaches, fever, chills, and other symptoms that usually go away within a day or two.
The COVID-19 vaccines, unlike many flu vaccines, are not made with eggs. They are therefore considered safe for people with egg allergies, although other ingredients can cause allergic reactions.
Will the vaccine distribution change?
Some have wondered whether the new vaccine, with its different properties, should be used more strategically rather than just adding it to the pool of available vaccines.
Since it doesn't need to be stored at freezing temperature like the other two, it may make sense to ship the J&J vaccine to rural communities and small practices that may not have pharmaceutical-grade freezers, said Julie Morita, executive vice president of the Robert Wood Johnson Foundation and member of President Joe Biden's transition team.
An advisory committee of the Centers for Disease Control and Prevention, due to meet on Sunday and Monday, could take up the idea of targeting distribution to specific population groups, she noted.
Morita hopes that increasing the overall range of vaccines will allow the shots to be distributed more fairly.
Balcezak of Yale New Haven Health said he viewed a third vaccine as "another variable that will create further potential for inequality".
In some ways, it makes sense to assign the J&J vaccine to inner-city neighborhoods that are finding it particularly difficult to fire one shot, no less than two.
"The challenge with this is that they naturally tend to get this less effective vaccine," he said. The country needs to "figure out how not to let this become another health inequality impact on our black and brown communities or our inner cities."
Goodman, co-chair of the COVID-19 vaccine analysis team, an expert group, said there wasn't much information on how the J&J vaccine will work in the elderly. Some have suggested that it might make sense to target the J&J vaccine at younger people who are less likely to have serious illnesses or die from COVID-19.
"It's early days to compare one vaccine with another," Goodman said on a call with reporters on Wednesday.
He would like to see major national studies on the performance of approved vaccines in the real world to better understand whether some vaccines are better suited to specific populations.
"This is how we will find out if these differences are real," he said.
Contact Karen Weintraub at kweintraub @ usatoday.
U.S. TODAY health and patient safety coverage is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide any editorial contributions.
This article originally appeared in the US TODAY: COVID Vaccine: Johnson & Johnson One-Shot Dose Turns 3rd in the US
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