The Food and Drug Administration authorized Johnson & Johnson’s coronavirus vaccine for emergency use for people 18 and older on Feb. 28. (Reuters)
By The Washington Post · Lena H. Sun
WASHINGTON – A federal advisory panel voted unanimously Sunday to recommend the nation’s third coronavirus vaccine for people 18 and older, opening the way for the one-shot, easier-to-use Johnson & Johnson vaccine to be administered starting this week.
Meeting in emergency session, advisers to the Centers for Disease Control and Prevention strongly endorsed the vaccine’s effectiveness in completely protecting against hospitalization and death. The Johnson & Johnson vaccine is the first one authorized in the United States that does not need to be kept frozen or followed by a second shot.
The clearance of a third vaccine comes at a critical time in the pandemic: After weeks of steadily declining new cases in the United States, the downward trend has stalled – “a very concerning shift in the trajectory,” CDC Director Rochelle Walensky said Friday. Experts worry that state and local officials are relaxing restrictions too quickly, and people are letting down their guard even as more contagious and possibly, deadly virus variants are on the rise. It was almost one year ago that authorities announced what was believed to be the first coronavirus death in the United States. Since then, more than 500,000 deaths of covid-19, the disease caused by the coronavirus, have occurred in the United States.
“Covid cases and deaths are decreasing,” said Beth Bell, a global health expert at the University of Washington who leads the panel’s coronavirus vaccine working group. “But the pandemic is very far from over and many challenges are before us. The need for more safe and effective vaccines remains urgent and vital to ending the pandemic.”
The action by the Advisory Committee on Immunization Practices follows the Food and Drug Administration’s action Saturday in authorizing the vaccine for emergency use for people 18 and older. Walensky is expected to approve the panel’s action shortly after the vote, making it an official CDC recommendation to health providers.
The doses are expected to start shipping as early as Monday to sites already receiving doses of the authorized vaccines made by Pfizer-BioNTech and Moderna. Those locations include state health departments, pharmacies, federally qualified health centers and community vaccination centers.
Johnson & Johnson’s initial supply will be limited – nearly 4 million doses are expected to be shipped this week, and an estimated 20 million doses by the end of March, officials have said. But state officials already know what to expect because the number of anticipated doses for all three vaccines was included in information they received last week.
The Johnson & Johnson vaccine was 85% effective at protecting against severe cases of illness in late-stage trials, and there were no deaths or hospitalizations a month after participants received the vaccine. The vaccine was slightly less effective at preventing moderate illness (72% effective in the United States) where more-transmissible variants have only recently begun to be detected. Some experts are worried that the public will fixate on that data point and pass up getting the Johnson & Johnson shot in favor of other vaccines that underwent trials at an earlier stage of the pandemic when such variants were not a factor.
Panel members said that doing so would leave people unprotected and delay an end to the pandemic.
Officials stressed that vaccines were tested at different times, against different circulating variants and in settings with different levels of transmission.
“While there are differences in efficacy of the three vaccines for moderate illness, the more severe the outcome, the more similar the efficacy,” said Saad Omer, director of the Yale Institute for Global Health who is not a member of the panel. “In other words, we now have three highly effective vaccines available in the U.S. – particularly against severe outcomes such as hospitalization and death. This one-dose vaccine, that can be stored at refrigerator temperatures, is likely to enhance the ability of health departments and health systems to conduct mass vaccination. The rate limiting step remains availability of doses.”
Members and immunization advocates expressed concern that information about the vaccine’s efficacy will be confusing for the public and make it even more difficult to get shot to hard-to-reach communities.
“We need some real plain language and clear public education on the difference between clinical trial efficacy and real world effectiveness,” Karen Ernst, who heads Voices for Vaccines, a parent advocacy group, said during the public comment period.
The second Covid-19 vaccination may cause fewer side effects compared to the first jab, Chulalongkorn University’s Centre of Excellence in Vaccine Research and Development director Kiat Rakrungtham said on Sunday.
He said only one of 1 million people have side effects due to the Covid-19 jab.
“The vaccine’s side effects are fever, aching muscle and pain in the spot where the jab was given,” he said.
He added that the vaccine will give maximum protection to people after receiving the second dose.
“Until then people still have to undergo measures to contain the spread of Covid-19, such as wearing face mask, washing hands and maintaining social distance,” he added.
Public Health Minister Anutin Charnvirakul became the first Thai person to be vaccinated against Covid-19 at Bamrasnaradura Infectious Diseases Institute in Nonthaburi province at 7.45am on Sunday.
Anutin was followed by Public Health Deputy Minister Sathit Pitutecha, Culture Minister Itthiphol Kunplome, Public Health permanent secretary Kiattiphum Wongrajit, Department of Disease Control director-general Opas Karnkawinpong and Education Deputy Minister Kanokwan Wilawan.
Chulalongkorn University virology specialist Dr Yong Poovorawan and medical personnel administered the Sinovac Covid-19 vaccine to the Cabinet members and senior government officials on Sunday morning.
Prime Minister Prayut Chan-o-cha was present as well to oversee the vaccination drive.
By The Washington Post · Laurie McGinley, Carolyn Y. Johnson
WASHINGTON – The Food and Drug Administration late Saturday granted emergency use authorization to Johnson & Johnson’s single-dose coronavirus vaccine, providing the United States with a long-anticipated tool that adds firepower and flexibility to the nation’s accelerating inoculation effort – but also presents new challenges.
Health authorities now have three effective vaccines, a singular scientific achievement that few would have predicted a year ago, when a pandemic emerged that has killed 2.5 million people worldwide, including more than 500,000 in the United States. It comes at a particularly fraught time, as Americans are whipsawed by encouraging developments, including sharp declines in nursing home deaths, and concerning news such as the emergence of potentially menacing variants.
With demand for vaccines outracing supply and officials scrambling to get much of the population vaccinated before variants spoil an improving picture, a third vaccine is “really good news,” said Eric Toner, senior scholar with the Johns Hopkins Center for Health Security. The vaccine will not have a big effect initially on supply shortages. Only a few million doses will be shipped to states in the days immediately after authorization, though production will ramp up in coming weeks, with 20 million doses to be delivered by the end of March and 100 million total in the first half of the year, according to the company.
The new vaccine has clear practical and logistical advantages over the first two vaccines – it does not have to be kept frozen, and there is no need for a second round of appointments. That makes it a boon for rural areas and other hard-to-reach communities, and for distribution to community health centers and physician offices that might not have the freezers needed for the other vaccines, public health officials say.
But the Johnson & Johnson shot also has a lower efficacy rate, leading some public health experts and government officials to worry that it will be viewed as substandard comparedwith the other vaccines. The Johnson & Johnson efficacy rate is 66% overall and 72% in the United States in preventing moderate to severe cases of covid-19, the disease caused by the coronavirus.
The vaccines by U.S. pharmaceutical giant Pfizer and its German partner BioNTech and by the biotech company Moderna are about 95% effective following their two-shot regimens.
Nirav Shah, director of the Maine Center for Disease Control and Prevention, said he is already getting tweets and emails from people expressing reservations. “The gentle ones say, ‘Is it okay if I get J & J, or should I wait for Pfizer?’ ” he said. “The strong ones say, ‘I don’t want J & J. I want Pfizer.’ “
Shah said he responds by saying all three vaccines have been shown to be fully effective in protecting against what people fear most – hospitalizations and death. And he notes that the two earlier vaccines were tested months before the emergence of “variants of concern,” including one first detected in South Africa that appears to affect the efficacy of the vaccines, so the results are not an “apples to apples” comparison. He urges people to get whatever vaccine they can.
Shah said he is planning to equip public health nurses and other vaccinators with the Johnson & Johnson vaccine and send them to far-flung corners of his state. “J & J will open up a new wing in our vaccination efforts – not just more people, but harder-to-reach people,” he said.
Jeanne Marrazzo, an infectious-disease doctor at the University of Alabama at Birmingham, placed the newest coronavirus vaccine in the context of vaccines used to thwart other infectious diseases.
“In a normal world, people would be jumping up and down for a vaccine that is more than 70 percent effective,” she said, noting that the FDA’s efficacy requirement is 50%. Instead, she said, “Some people are saying, ‘I am going to wait until I get the good vaccine.’ “
She doesn’t want the residents of Alabama’s rural areas – which tend to be less affluent and have a significant percentage of African Americans – to feel they are getting shortchanged if Johnson & Johnson’s product is deployed there.
“It’s something you have to think about as you make vaccines available because people are making comparisons,” Marrazzo said.
Paul Goepfert, director of the Alabama Vaccine Research Clinic and one of the scientific leaders of the Johnson & Johnson trial, said emerging evidence in the United Kingdom shows that the protection provided by the vaccine is similar to that from a single dose of Pfizer.
“Dose for dose, this vaccine is as good as any of the other ones,” he said. “I think the messaging needs to be this vaccine is comparable to the other two vaccines, and as soon as you have the availability [to take any vaccine], you should take it.”
But some experts say it is important for people to understand there might be differences between vaccines in preventing moderate cases of covid-19, because even those infections could have long-term consequences. At the same time, some doctors say they are encountering people saying they prefer the Johnson & Johnson vaccine because they don’t want to have to get a second shot.
For now, consumers are unlikely to have a choice of vaccines because there simply isn’t enough supply. That is poised to change in coming months. Pfizer-BioNTech and Moderna have committed to delivering a total of 220 million doses by the end of March. They say they have solved manufacturing challenges and are in a position to overcome scarcity that has hampered the nation’s fight against the coronavirus.
Some experts expect the United States will reach an inflection point by late spring, with more shots available than people who want to get them. A vaccine developed jointly by the University of Oxford and AstraZeneca and another from Maryland biotechnology company Novavax are also in the late stages of testing, and the United States has contracts for 400 million doses, if the vaccines are successful.
The addition of the Johnson & Johnson shot will diversify the nation’s portfolio of vaccines, adding one that works through a different scientific technology.
The Pfizer-BioNTech and Moderna vaccines employ an approach that had never been used in people outside of clinical trials. They deliver a strip of genetic material called messenger RNA carrying the instructions to build the spiky protein found on the outside of the virus.
In contrast, the Johnson & Johnson vaccine uses a harmless cold virus to deliver a gene encoding the spike protein to cells. The approach is more established. In both cases, cells follow genetic instructions to construct the spike, and the immune system learns to recognize the real thing from these replicas – and to respond.
The latest vaccine will also add a new supply stream to help alleviate shortages or manufacturing delays. A different process and supply chain are used, which could help bolster confidence that if any of the vaccines runs into production difficulties, there will still be supply.
“It’s always better to have that – if one vaccine gets in trouble for some reason or isn’t being produced at a high enough rate. That’s the most common problem we see when a new vaccine is produced: shortages,” said Nancy Bennett, professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry. “The more the merrier.”
The advantages of each vaccine against the pathogen are still being untangled. Although a single shot of the Johnson & Johnson vaccine didn’t trigger antibody levels to soar sky high, it offered good protection against variants. Scientists think that could be because the vaccine robustly triggered another arm of the immune system, T cells, that may provide a different layer of protection.
Johnson & Johnson’s Janssen Pharmaceuticals unit applied to the FDA for emergency use authorization for the vaccine Feb. 4, submitting clinical trial data involving 44,000 participants in eight countries. On Wednesday, the agency released its analysis that the vaccine was safe and effective. On Friday, the agency’s outside vaccine advisers voted unanimously to recommend authorization.
The Centers for Disease Control and Prevention is scheduled to have an emergency meeting Sunday to review the safety and efficacy data and to recommend who should get the vaccine.
Meanwhile, vaccine makers in recent days announced progress on work designed to counter viral variants.
Moderna said it has made a new version of its vaccine targeting the variant first identified in South Africa. A small amount of vaccine has been sent to the National Institutes of Health for a trial to determine whether boosting humans with the modified vaccine will stimulate a strong immune response, the company said.
Pfizer and its partner BioNTech said they have started testing a third dose of their original coronavirus vaccine to see how well it protects against variants. They are also doing work aimed at variants of concern.
For scientists who have long worked on vaccines, the scale and velocity of the coronavirus research has been stunning. Goepfert, an HIV researcher who worked on the Johnson & Johnson trials, said the HIV vaccine trials he has worked on might have had as many as 5,000 participants, but the Johnson & Johnson study recruited 44,000 people in about 2½ months.
“What’s fascinating about covid vaccine studies is at first we were worried about enrolling the right kind of people at risk. But everybody’s at risk. You just needed to enroll people,” Goepfert said. “I think that’s sadly what helped us get these vaccine end points.”
The Johnson & Johnson study also might help elucidate some questions that are beginning to arise from real-world use of the vaccines. Goepfert said there were health-care workers in the trial who received the Johnson & Johnson vaccine but then became eligible for an authorized vaccine midway through and received one of the messenger RNA vaccines. Scientists have continued to collect safety data on those people, which should help show whether there are obvious risks from the mixing and matching that may begin to occur in the future, particularly as companies begin testing additional booster doses as a way to protect against variants.
For Helen Boucher, an infectious-disease doctor at Tufts Medical Center in Boston, the events of the past several weeks have been both devastating and exhilarating.
“We have hit this unfathomable number of people who have died and just thinking about it is overwhelming,” she said. At the same, she noted, hospitalizations and deaths are declining and vaccinations are increasing.
“I feel like there is light ahead,” she said. “I think the data supports it.”
Dermatology experts at the Department of Medical Services said on Wednesday that cats may transmit fungal disease to humans.
Dr Somsak Akksilp, the department’s director-general, said fungal disease usually causes a red rash that may leave black marks on the skin, which takes a long time to fade.
“Other furry animals like dogs and hamsters may also transmit fungal disease,” he said.
Dr Mingkwan Wichaidit, director of the Institute of Dermatology, said the fungus commonly found in cats is Microsporum canis, which can give humans an itchy rash.
“The most vulnerable to fungal disease are children, the elderly and those with low immunity,” she said, adding that people with fungal disease should see the doctor immediately.
“To prevent transmission, people should wash their hands after touching their pets, have them vaccinated and take good care of their pet’s fur,” she said. “Pets should also immediately be taken to the veterinarian if they develop a rash or start losing fur.”
FDA review confirms safety, efficacy of single-shot Johnson & Johnson coronavirus vaccine, especially against severe cases
Health & BeautyFeb 25. 2021Sean Kirk, executive vice president of manufacturing and technical operation, visits employees in a lab at Emergent Biosolutions, which is manufacturing vaccines for AstraZeneca and Johnson & Johnson, on Feb. 8, 2021 in Baltimore. MUST CREDIT: Washington Post photo by Michael Robinson Chavez
By The Washington Post · Carolyn Y. Johnson, Laurie McGinley
WASHINGTON – A third coronavirus vaccine could soon be available in the United States, a one-shot regimen made by pharmaceutical giant Johnson & Johnson that proved safe and effective in a clinical trial and completely protective against hospitalizations and deaths, according to a Food and Drug Administration review released Wednesday.
The document, posted in advance of an all-day meeting of FDA advisers Friday, sets the stage for a vaccine to be authorized as soon as this weekend. As the threat of virus variants continues to swirl, the prospect of another vaccine that could accelerate immunization efforts and prevent more variants from emerging offers hope in the middle of a pandemic that has killed more than a half-million people in the United States.
Public health officials have eagerly awaited the arrival of the Johnson & Johnson vaccine because it is easier to store and administer and could streamline the logistics of a complicated mass vaccination campaign. But supply will continue to limit the nation’s vaccination efforts in the near term, with the full impact of the Johnson & Johnson vaccine not expected until April as manufacturing scales up. If the vaccine is authorized this weekend, federal officials predicted that 3 million to 4 million doses could be allocated next week, with an additional 20 million expected in March.
But the FDA review also hinted that a formidable messaging challenge may lie ahead. After the spectacular and relatively straightforward 90-plus percent effectiveness of the first two coronavirus vaccines that were authorized, the Johnson & Johnson results are more nuanced.
Johnson & Johnson’s one-shot vaccine was tested during a more complicated phase of the pandemic, when a variant capable of slipping by some immunity had emerged. It was more than 80% effective at preventing severe illness, including in areas of the world where concerning variants are circulating, but only 66% protective overall when moderate cases were included.
Experts say people should not insist on getting vaccines with higher efficacy rates, considering that a joint vaccine from pharmaceutical giant Pfizer and German biotech firm BioNTech, and one from biotech company Moderna went through clinical trials earlier, before certain variants emerged. They fear the logistical advantages of Johnson & Johnson’s vaccine could be lost if people decide to defer vaccination until they can access a particular shot. Vaccines that transform the virus from a potentially fatal disease into a nuisance illness could end the pandemic, unless they aren’t widely adopted.
“We know this vaccine prevents 85 percent of the severe disease. . . . It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important,” said Nancy Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry. “Those facts are the most important thing to recognize.”
The FDA scientists found that the “known benefits” of the vaccine included reducing the risk of symptomatic and severe cases of the disease caused by the virus, covid-19, at least two weeks after vaccination. The review found vaccine efficacy against severe covid-19 “was similarly high across the United States, South Africa, and Brazil.”
People working on the logistics of vaccination see clear benefits from the Johnson & Johnson vaccine because it can be stored in a refrigerator for at least three months, making it simpler to use than other vaccines that must be kept frozen. And because it is a single shot, it does not require a follow-up visit for a booster shot.
The vaccine’s efficacy rate was lower – 42% – in preventing moderate to severe illness in a subgroup of adults older than 60 who had medical risk factors. But regulators noted that the statistical significance of that finding was uncertain, and no deaths or cases requiring medical intervention were reported a month after those older adults received vaccines. Overall, there were seven deaths in the trial, all in the group that received a placebo.
David Benkeser, a biostatistician at Emory University’s Rollins School of Public Health, said that the lower efficacy in some older study participants warranted additional study but wasn’t yet a huge concern. He noted that the lower efficacy seemed to be driven by older adults with diabetes, and it would be important to check whether their immune responses to the vaccine were lower.
“There’s a chance that this is a bit of bad luck – if you cut the data up many ways, you are bound to find some puzzling results,” Benkeser said in an email. “For now, the news is overall very positive.”
Still, the lower efficacy among higher-risk older adults could be a topic of discussion when outside experts meet Friday to recommend whether the FDA should authorize the shot. If the regulatory deliberations follow the path of the previous two authorized coronavirus vaccines a decision could come this weekend.
The FDA advisory committee will consider the Johnson & Johnson vaccine at a “very tenuous time,” said Nahid Bhadelia, an infectious-disease doctor at Boston Medical Center. “Nobody knows how to feel.” While hospitalizations and deaths related to covid-19 are declining, there are concerns that variants could spoil the improving picture.
The Johnson & Johnson results highlight the challenge variants pose to all of the vaccines: The large, international trial found the vaccine was 72% effective at preventing cases of moderate to severe covid-19 in the United States, where variants of concern have only recently begun to be detected. In South Africa, where a variant capable of evading some parts of immunity became dominant late last year, it was 64% effective against moderate to severe illness.
That drop-off is smaller than has been seen for some other vaccines. The vaccine developed by Novavax was nearly 90% effective in a British trial, but that protection fell to about 50% in South Africa. The vaccine developed by AstraZeneca and the University of Oxford, which was estimated to be 76% effective in preventing symptomatic infections in trials before variants emerged, was suspended in South Africa after a small study suggested it did not appear to protect against the variant there.
Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, whose laboratory helped design the vaccine, said protection against the variant was “quite good,” although he said that all vaccine developers are preparing for the possibility they will need to redesign vaccines for the variants.
Barouch’s work in monkeys provides a clue as to why the vaccine’s protection may have remained robust against the variant. Studies have shown that antibodies triggered by various vaccines are less effective against the variant first detected in South Africa, leading to fear that vaccines would no longer be protective. But those antibody tests don’t capture the full immune response, and his work showed that the response from another prong of the immune system, T cells, is triggered strongly by the Johnson & Johnson vaccine in animals.
“The J & J vaccine, if it is approved by the FDA, is going to increase vaccine supply for the country and the world,” Barouch said. “That’s incredibly important, because we need to immunize our country and our world as quickly as possible to end this pandemic and to prevent the emergence of new variants in the future that might be even more concerning than the current ones.”
The results suggest that the protection generated by the vaccine will prevent people from the worst outcomes, even if it allows some cases of coughs and fevers to slip by. The vaccine was more than 80% effective at preventing severe illness in South Africa.
There was also preliminary evidence that the vaccine may protect against asymptomatic infections, a key question about vaccines throughout the pandemic.
Blood tests from 2,650 study participants showed that two months after being vaccinated, 37 trial participants who received the placebo had evidence of asymptomatic infection. But only 10 of the participants who received the vaccine had similar markers in their blood. That suggested the vaccine reduced by 74% the threat of asymptomatic infection.
The FDA, which on Monday issued new guidance to manufacturers on how to deal with variants, has emphasized being ready to possibly update vaccines. To streamline the process for getting clearance for modified vaccines, the FDA said, companies will be able to submit smaller studies testing immune responses in people’s bodies rather than lengthy, large trials in which researchers give half the participants a placebo and wait to see if people get sick or not.
Several manufacturers, including Johnson & Johnson, are studying potential modifications to their vaccines to counter variants such as those first detected in the United Kingdom and South Africa.
The FDA described the vaccine as having a “favorable safety profile,” with the most common side effects including pain at the injection site, headache and fatigue. It said one patient had a “serious event of a hypersensitivity reaction” – an allergic reaction that was not classified as anaphylaxis – two days following vaccination.
If an emergency use authorization is granted, about 2 million doses are expected to be shipped to states next week, while another 1 million to 2 million doses could be sent directly to pharmacies and other sites, federal officials said. That will make only a slight dent in the vaccine shortage affecting the nation. But supply will ramp up quickly in April.
In Europe, where the vaccine from AstraZeneca and the University of Oxford is available in addition to Pfizer-BioNTech and Moderna, societal debate has flared over whether people should be able to choose which vaccine they get.
“We have a really important job to do on how we message this,” said E. John Wherry, an immunologist at the University of Pennsylvania. “The day that an individual has a choice on which vaccine to get – that’s a great day, but probably won’t be until summer.” Until then, he said, people should take the vaccine they can get, because all are robustly effective.
Sean Kirk, executive vice president of manufacturing and technical operation, visits employees in a lab at Emergent Biosolutions, which is manufacturing vaccines for AstraZeneca and Johnson & Johnson, on Feb. 8, 2021 in Baltimore. MUST CREDIT: Washington Post photo by Michael Robinson Chavez
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