CDC panel recommends Pfizer, Moderna vaccines over J&J attributable to uncommon blood clot circumstances

A health care worker holds a dose of the Johnson & Johnson vaccine.

Phill Magakoe | AFP | Getty Images

An advisory board for the Centers for Disease Control and Prevention on Thursday recommended Pfizer and Modern‘s vaccines over Johnson & Johnson‘s shot for adults ages 18 and up after dozens of people found a rare blood clot after the J&J vaccination, all of whom were hospitalized and nine of them died.

The Advisory Committee on Immunization Practices has unanimously decided to recommend Pfizer and Moderna over the Johnson & Johnson vaccine. CDC director Rochelle Walensky has yet to accept the recommendation.

The CDC has confirmed 54 cases of people who develop blood clots and have low blood platelet levels, a new condition known as thrombosis with thrombocytopenia syndrome that mainly affects younger women. All patients were hospitalized, nine people died and 36 were treated in the intensive care unit.

The US has administered more than 17 million J&J doses since the Food and Drug Administration approved the emergency syringe in February.

“TTS case reporting rates after Janssen vaccines are higher in men and women in a wider age range than previous estimates,” said Dr. Keipp Talbot, chairman of the CDC’s vaccines and safety subgroup, the advisory body.

Although the panel’s recommendation was unanimous, some members struggled with the vote. The CDC experts could also have recommended giving up the shot altogether or restricting it to certain age or demographic groups.

Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University, said he was not recommending J&J admission to any of his patients, despite ultimately standing for the panel’s proposal.

“I just can’t recommend a vaccine associated with a disease that can lead to death,” Sanchez told the committee. “I don’t recommend it to any of my patients’ parents.”

Seven of the patients who died were women and two men, with a mean age of 45 years. Most of the deceased had previous health conditions such as obesity, high blood pressure and diabetes. The death reporting rate was 0.57 deaths per million doses administered, according to the CDC.

“In reviewing these cases, we noticed how quickly patient status deteriorates and leads to death,” said Dr. Isaac See of the CDC’s Vaccine Safety Team joined the advisory board.

According to the CDC, patients typically developed symptoms 9 days after vaccination and were hospitalized 5 days after symptoms appeared. The overwhelming majority of patients were women, 37 total, and the mean age was 44. Seventeen men developed TTS.

Johnson & Johnson’s director of global therapeutic vaccines Penny Heaton defended the company’s shot during the meeting, saying it “saves lives here in the US and on every continent around the world”.

“It’s easy to store and transport,” said Heaton. “In many low- and middle-income countries, our vaccine is the primary and sometimes even the only option in the US as its permanent protection may be the preferred choice for people who cannot or do not want to return for multiple vaccinations.”

Heaton said J&J recognizes the incidents of TTS related to the vaccine and that the condition can be fatal, although cases are rare. She said patient safety and wellbeing remain a top priority for J&J, and the company has several studies underway to identify risk factors related to developing TTS.

In April, the Food and Drug Administration and the CDC stopped briefly the use of the Johnson & Johnson single vaccine after six adult women developed blood clots and low platelet counts at the same time.

A week later, the FDA and the CDC did canceled the break on J&J shots after the independent advisory panel said the benefits of the shots outweigh the risks. At the time, the panel did not recommend restricting admissions based on age or gender. It suggested that the FDA put a warning label on for women under 50.

The FDA has advised health care providers not to give a J&J booster to people who have developed TTS in the past after the first injection. The FDA also said the J&J syringe should not be given to people who received the vaccine from AstraZeneca, even though AstraZeneca is not approved for use in the United States

CDC experts said Thursday that people who received J&J booster doses have not seen any cases of TTS, although the number of boosters is relatively small.

“Currently available evidence supports a causal relationship between TTS and the Janssen COVID-19 vaccine,” the FDA said in the factsheet for healthcare providers.

In October, the FDA and CDC approved authorized J&J boosters for all adults at least two months after receiving their first J&J syringe. More than 800,000 people have received J&J boosters, according to CDC data. People who received their primary vaccination with the J&J shot can also be boosted with the Pfizer or Moderna vaccines.

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FDA panel unanimously recommends Moderna Covid booster pictures for at-risk adults

A key advisory committee to the Food and Drug Administration unanimously recommended Thursday that booster shots be taken from ModernCovid-19 vaccine for people 65 and older and other Americans at risk. The vote was a critical step before the US can begin giving third vaccinations to some of the more than 69 million people who originally received this vaccine.

The non-binding decision of the Advisory Committee on Vaccines and Allied Biological Products of the FDA would extend the guidelines for Moderna with the third recordings of the FDA PfizerBioNTech Vaccination. These recordings were authorized less than a month ago to a wide range of Americans, including the elderly, adults with pre-existing medical conditions, and those who work or live in high-risk environments such as healthcare and grocery stores.

Although the agency has not always followed the advice of its committee, it often does. A final FDA decision on Moderna boosters could be made within days. A CDC Vaccines Advisory Committee is then expected to vote on the FDA’s proposal next week. If it recommends approval and the CDC endorses it, eligible Americans who completed their vaccinations at least six months ago could begin booster vaccinations immediately.

Booster vaccination has been a controversial issue for scientists – inside and outside of government – especially since many people in the US and other parts of the world have not yet received a single dose of a vaccine. The World Health Organization is urging wealthy countries to wait before distributing boosters, and some scientists say they are not convinced that most Americans need boosters right now.

When the FDA committee met last month, they opposed a proposal to distribute booster vaccines from Pfizer and BioNTech to the general public. Some committee members said at the time they were concerned that there wasn’t enough data to make a recommendation, while others argued that third shots should be restricted to specific groups.

After Moderna’s unanimous vote on Thursday, committee member Dr. Patrick Moore said the data the company submitted for approval of a booster was “not well explained,” adding that he was more on “gut instinct”.

“The data itself is not strong, but it is certainly going in a direction that supports this vote,” he said.

Some members said the boosters should prevent what they call breakthrough infections, which they believe are critical to protecting healthcare facilities from being overloaded, while other members said the third vaccinations should ensure high-risk patients don’t have serious illnesses. Some committee members also suggested that young people might not need boosters as the first few shots in these groups still persist.

Dr. Another member, Paul Offit, stressed that most people who received the first two doses of Moderna’s vaccine are still well protected and hopes the recommendation doesn’t send the “wrong message” to the public.

“If we’re trying to prevent the inevitable, which is a decline in neutralizing antibodies and an erosion of protection against mild or asymptomatic infections, that’s a high bar that we don’t hold any other vaccine by,” he told his colleagues.

The Biden government hopes the extra dose will provide long-term and permanent protection for the US population from serious illness, hospitalization, and death as the fast-paced Delta variant continues to spread.

Dr. Peter Marks, the FDA’s chief vaccine regulator, reached the committee Thursday before the vote, telling the panel of experts that the agency is promoting “all the different viewpoints” on the “complex and evolving” data.

“However, I would ask you, as we move forward, to do our best to focus our reflections on the science related to the proposal under consideration today and not on operational issues related to a booster campaign or related issues global vaccine justice. ”he added.

Moderna filed for FDA approval of a booster dose on September 1. The company said the results are based on a clinical study of about 170 adults, fewer than the 318 people screened for Pfizer’s booster vaccination. Moderna said a third half-dose shot – 50 micrograms – was safe for the first two injections and produced a strong immune response.

Once approved, the company plans to send a letter to health care providers explaining the dose difference for the third injection, said Dr. Jacqueline Miller, the company’s director of infection research, during a presentation Thursday.

The side effects of Moderna boosters were similar to those after the second dose, the company wrote in a document released Tuesday by the FDA. Most of the side effects were of minor severity and Moderna reported no cases of rare heart inflammation, myocarditis, or pericarditis in subjects for up to 29 days after receiving the booster.

Before recommending the third shots, the panel listened to several presentations, including from Israeli health officials, who began to offer boosters to their populations before many other countries. The country has mainly used Pfizer’s vaccine, but some Moderna boosters have been given.

Israel has given 3.7 million third vaccinations since its booster campaign began in late July, with about a third of the extra vaccinations going to people aged 60 and over, Sharon Alroy Price, director of public health at Israel’s Ministry of Health, told the panel.

She presented data suggesting that people receiving a booster dose are less likely to get infected with Covid or become seriously ill. She said officials have so far identified 17 cases of myocarditis or pericarditis after third doses.

“I think we can say, if we look at all of the data in Israel so far, that the use of booster doses has helped Israel reduce the infections and the severe cases,” she said.

– CNBC’s Robert Towey contributed to this report.

FDA panel recommends Pfizer’s Covid booster doses for individuals 65 and older

An influential advisory committee to the Food and Drug Administration on Friday rejected a proposal to distribute booster vaccinations from Pfizer and BioNTech Covid-19 Vaccine to the general public and scaled back those plans, unanimously recommending the third vaccination to people 65 and older and other at-risk Americans.

“In my opinion it is likely to be beneficial for the elderly and eventually could be indicated for the general population. I just think we’re not there yet in terms of the data, ”said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

The panel voted 16-2 against distributing the vaccines to Americans 16 and older before unanimously adopting an alternative plan to give boosters to older Americans and those at high risk of developing serious illness if they got the virus receive. This previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

Pfizer stock closed 1.3% while BioNTech’s shares fell 3.6%.

The non-binding decision of the FDA’s Advisory Committee on Vaccines and Related Biological Products comes as the Biden government announced that it would begin offering booster vaccinations to the general public as early as next week pending approval from US health regulators . Although the agency has not always followed the advice of its committee, it often does. A final FDA decision could be made in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third syringes in the United States

“We’re not tied to your voice at the FDA just for you to understand. We can adjust this as needed,” recalled Dr. Peter Marks, the agency’s top vaccine regulator, joined the panel after the votes. He asked the group for suggestions on what other populations the FDA should consider for boosters, such as frontline health workers and other professions exposed to higher levels of exposure to Covid.

It was expected that the committee vote would be controversial, as some scientists included two senior FDA Officials involved in Friday’s meeting said they were not entirely convinced that every American who received the Pfizer vaccine now needs extra doses.

White House senior medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t recommend the shots for anyone 16 and older. Fauci, who publicly supported Booster, hesitated in an interview on Friday “Closing bell“To guess what the committee would ultimately decide.

“I don’t want to pre-empt the advisory committee at the time they are deliberating,” he said.

Liesl Eibschutz, a Dartmouth University medical student, loads a syringe of Pfizer COVID-19 vaccine before giving the vaccine on the first day people 16 and older get the vaccine at Kedren Health on Thursday, Angeles, California.

Allen J. Cockroaches | Los Angeles Times | Getty Images

In published a paper Days before the advisory committee meeting, a leading group of scientists said the available data showed that vaccine protection against serious illnesses persists, even as efficacy against mild illness wears off over time. The authors, including two senior FDA officials and several World Health Organization scientists, argued Monday in the medical journal The Lancet that widespread use of booster syringes to the general public is currently inappropriate.

In the outlines of the plans for last month’s launch Distribute booster next week, Biden administration officials cited three CDC studies showing that vaccine protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illnesses, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

Before the vote, some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third shot should be limited to specific groups, e.g. illness. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.

Dr. Hayley Gans, a voting member, said she was “concerned” that the FDA asked the committee to review the entirety of the evidence presented Friday because some data, including on safety, were still inadequate.

Another member, Dr. Paul Offit said he would support boosters for people over 60 but struggled to support a third vaccination for younger groups due to a higher risk of myocarditis.

Ahead of Friday’s vote, the committee listened to several presentations on data supporting the widespread use of booster vaccinations, including by health officials in Israel, where officials began vaccinating the country’s population before many other countries and their citizens later July.

Phil Krause, an FDA vaccine regulator and co-author of The Lancet, criticized the results presented Friday, saying that much of the data had not been federally vetted or peer-reviewed. He said the models used are complex and scientists need to make sure they are “getting the right results.”

“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.

In documents released by the FDA on Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30, when the rapidly expanding delta variant emerged across the country.

In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. Health officials began to see a trend that people in their 40s and 50s who were fully vaccinated became seriously ill with Covid.

“We didn’t want to wait for these results and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”

She also said the booster was well tolerated by many people, citing data showing that out of approximately 2.9 million people who received the additional doses, there was only one case of myocarditis, a rare inflammation of the heart that occurred with mRNA vaccines.

Pfizer’s booster side effects are also similar to those seen after receiving the second dose of vaccine, said Dr. Joohee Lee, an officer with the FDA’s Office of Vaccines Research and Review, during the meeting.

Of the 289 booster recipients, ages 18 to 55 years old, observed in Pfizer’s Phase 3 study, 63.8% developed fatigue, 48.4% headache, and 39.1% muscle pain. The FDA examined side effects in 2,682 recipients of Pfizer’s second dose of Covid aged 16 to 55 years and reported fatigue in 61.5% of patients, headache in 54%, and muscle pain in 39.3%. One adverse event – swelling of the lymph nodes – occurred in 5.2% of booster recipients but only 0.4% of those who received their first two doses.

“The majority were mild to moderate and they resolved,” Lee said of the lymphadenopathy cases. “Though one is reported to be underway right now.”

School Gamers Could Make Cash Off Their Fame, Highly effective N.C.A.A. Panel Recommends

Leader of the NCAA, the most influential umbrella organization in university sports, existed for months that they are keen to move forward with new guidelines to provide players with greater economic opportunities. And while many athletics leaders pushed the 115-year-old federation to relax its long-standing restrictions, the college sports industry now acts largely because it had little choice.

In Alabama, Florida, Georgia, Kentucky, Mississippi, New Mexico, Ohio, and Texas, laws or executive orders will go into effect Thursday that will allow college athletes to make money using their names, pictures, and likeness. More than a dozen other states have adopted similar measures with later entry into force. But Congress got in a setback to the NCAA no agreement reached to override state laws and write a standard in federal law.

While many administrators still hope that the federal government will act at some point, the plethora of state laws – often denounced as “patchwork” by athletics officials – threatened to create an immediate imbalance in college sports. Schools in states with legal guarantees that students could potentially make money, the argument goes, would be better positioned to recruit potential players and would draw the greatest future talent to a handful of schools. The NCAA’s decision to intervene, executives hope, will avert the worst possible inequalities, at least for a short time.

Still, the road to Monday’s recommendation was speckled with internal fighting, caution, threats and last-minute maneuvers. No recent development has been more momentous than the Supreme Court ruling last week, which undermined the NCAA’s approach to antitrust law and urged the industry to give athletes more rights than top executives once expected.

The NCAA v Alston case was closely focused on educational benefits such as academic awards and paid internships, but the court’s unanimous ruling removed some of the legal precedents that the association and its members had relied on for decades for protection. The decision unnerved college sports officials, many of whom were already drained by seemingly endless legal battles, and heightened concerns that a string of tough NCAA name, image, and likeness rules would create more legal challenges and perhaps even more pronounced defeats .

Excessive Peaks group recommends hiker permits, more cash for Adirondacks

Cars in a trailhead parking lot along State Route 73 can be seen here on Labor Day weekend in 2020. (Photo – Elizabeth Izzo, Adirondack Daily Enterprise)

The State Department of Environmental Conservation has published recommendations from a committee on how to address the ever-increasing migratory traffic in the high peaks.

The 55-page report, which was in the works for over a year, contains mostly suggestions familiar to longtime Adirondack residents. The report suggests that the DEC investigate a walking permit system to limit usage – something that DEC Commissioner Basil Seggos has called a “last resort” to alleviate usage problems. It is also suggested that the state allocate more resources to address the effects of overuse, develop a strategic plan for visitor usage management, implement management plans already in the books, and put together an online system that will give visitors real-time information on the conditions of the trails and provides parking, starting a pilot shuttle service on State Route 73 and pilot visitor management plan on private land, and increasing the number of rangers and stewards in wilderness areas.

The report also called on the DEC to set up another committee to “lead the development of the Strategic Plan,” establish a new outdoor recreation unit under the umbrella of the DEC, and adopt some of the US National Park Service guidelines for visitor management.

These recommendations come at a time when the state is grappling with a multi-billion dollar budget gap. Although the federal US rescue plan – the latest coronavirus aid package – will provide the state with unrestricted aid worth $ 12.6 billion, Governor Andrew Cuomo has stated that the state needs $ 15 billion. Representatives of the Empire Center for Public Policy, a fiscal conservative think tank in Albany, have claimed Cuomo’s estimate is exaggerated.

This report completes the work of the High Peaks Strategic Planning Advisory Group, a committee established by the DEC in November 2019. Its formation followed the summer and fall seasons, when the waves of hiking traffic overwhelmed local resources on days with good weather. The impact of the busy seasons was compounded by a roadside parking ban along Route 73, which was introduced in May 2019. The ban was designed to address public safety concerns, but ultimately caused confusion and frustration as visitors were nowhere to park or park illegally despite no parking signs.

Despite the closure of the US-Canada border, these pre-existing problems worsened last summer. Rather than discouraging visitors outside the city from getting to the Adirondacks, the coronavirus pandemic brought even more visitors to the High Peaks region as people searched for places to escape after months inside. An influx of first-time visitors also brought more cases of litter and abuse of public land. The DEC set up pop-up hikers’ booths in Keene, Lake Placid and North Hudson last summer to keep visitors informed.

The High Peaks Advisory Group was asked to formulate a “strategic planning framework” that included policy recommendations to achieve five main goals: ensuring public safety, protecting hiking trails and natural resources, providing a good outdoor experience for visitors, and providing assistance local people’s economy and decisions based on science and data.

The group includes former Adirondack Council Director of Conservation Rocci Aguirre; Lawyer Sandra Allen; Teresa Cheetham-Palen, Keene Councilor and co-owner of the Adirondack Rock and River Guide Service and the Lodge; Essex County Chairman Shaun Gillilland, R-Willsboro; Seth Jones, director of education, Adirondack Mountain Club; Jim McKenna, CEO of the Regional Sustainable Tourism Office; Pete Nelson, co-founder of the Adirondack Wilderness Advocates; SUNY ESF professor Jill Weiss; Keene City Supervisor Joe Pete Wilson Jr .; and Charlie Wise, owner of the Mountaineer equipment store in Keene Valley.

The group submitted this report to DEC late last year, but the department waited until last week to publish it. A smaller interim report was presented to Seggos last summer. The department also waited weeks to release this report.

Some of the recommendations in this report are more than two decades old – they were set out in the High Peaks Wilderness Unit’s 1999 Management Plan and never materialized. Others have already been included in subsequent amendments to this plan, but have not yet happened. Some of the recommendations the DEC is already implementing, such as enforcing parking regulations along Route 73, partnering with Essex County to launch a pilot walker shuttle system, and posting information about parking availability and closings on social Media and government websites.

In a press release, Adirondack Wilderness Advocates said that “the high peaks need better protection than wilderness”.

“We are concerned that others will shout ‘overuse’ and lead with solutions before the problems and challenges of visitor usage are understood and measured,” the press release said. “We believe that science, data and planning must come first, even when trying out short-term strategies.”

In a statement, Adirondack Council Executive Director Willie Janeway praised the report. Prior to becoming head of the Environmental Advocacy Group, he was DEC regional director for the Catskills and the Hudson Valley.

“If adopted, these measures would be a significant leap towards first class management of this world class resource,” he said. “That means both a healthier wilderness and a happier visitor.”

Janeway highlighted a three-year pilot program that first tested the use restrictions for private land. The DEC passed the National Park Service guidelines and called for a new outdoor recreational unit. He also reiterated the recommendation for more funding.

“The Adirondack Council and its partners have requested an investment of $ 500 million over the next five years in these efforts and other measures to protect the park, maintain clean water and support the community,” a council press release said .

Seggos did not say which of the DEC committee’s new recommendations would ultimately implement.

“I am absolutely 100% convinced that the DEC … their heart is in the right place,” said Wilson, the committee member and Keene Town supervisor. “They were committed to the process and gave us all the tools we needed to have these discussions and make these decisions. You stand behind the recommendations that we made for the report.

“There’s a lot more going on in the world than just managing the high usage in the Adirondacks and the High Peaks,” he added. “I think these larger forces will really determine how much the state can address right now. From an optimistic point of view, we are having discussions about how the administration in Keene, the transport, more toilets, a stronger contact with education and visitors can be promoted. I really feel like the DEC worked right on doing this as we prepare for summer. With that in mind, it’s a big problem that needs to be addressed. It will take a lot of work and a lot of requirements to face and recover from the ongoing public health crisis. I am ready to continue our work and be patient. “

A full copy of the committee’s report is available at www.dec.ny.gov/images/lands_forests_images/hpacfinalreport.pdf.

FDA panel unanimously recommends emergency use

A key advisory body to the Food and Drug Administration was unanimously supported on Friday Johnson & Johnsonis single shot Coronavirus Emergency vaccine, a crucial step paving the way for a third preventive treatment to be distributed in the US next week.

The non-binding decision, made 22-0 by the FDA’s Advisory Committee on Vaccines and Related Biological Products, comes because the Biden government is working to increase the supply of vaccine doses and get Americans vaccinated as soon as possible. US health officials are increasingly concerned about new emerging variants of the virus, particularly South African strain B.1.351, which has been shown to reduce the effectiveness of vaccines on the market and under development.

The head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, warned earlier Friday that the decreases in Covid-19 cases reported in the US since the beginning of January could flatten as the variants continue to spread.

“In the past few weeks, cases and hospital admissions in the US have decreased since early January, and deaths have decreased over the past week,” Walensky said during a press conference at the White House. “However, the latest data suggests that these declines may stall and possibly weaken if a number is still very high.”

Scaling-up vaccinations could help mitigate the effects of the highly contagious variants, Adam MacNeil, epidemiologist at the CDC, said during a presentation the Friday before the vote. He added that The US “is not close to herd immunity”But vaccinations could help “bring us closer to closing the herd immunity gap”.

The FDA advisory panel plays a key role in approving flu and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not have to follow the advisory board’s recommendation, it often does. For similar inquiries from Pfizer and ModernThe FDA approved these companies’ vaccinations the day after the committee endorsed the emergency use approval. If J&J follows the pattern, a third vaccine could be approved on Saturday.

After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there is insufficient supply Pfizer and Moderna gives vaccinations.

“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.

Initially the doses would be limited. The U.S. plans to ship 3 to 4 million doses of J & J’s vaccine to states, pharmacies and community health centers next week pending FDA approval, President Joe Biden’s Covid czar Jeff Zients told reporters on Wednesday . The company expects to drop 20 million cans by the end of March. Dr. Richard Nettles, Vice President of Medical Affairs, J&J, said House Legislators on Tuesday. J&J has signed a contract with the US government to deliver 100 million doses of its vaccine by the end of June.

Federal and state health officials have been eagerly awaiting approval of J & J’s vaccine. Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J&J only requires one dose, which makes logistics easier for healthcare providers. J & J’s vaccine, unlike the other two vaccines, which must be stored at subzero temperatures, can also be stored at refrigerator temperatures for months.

J & J’s single-dose vaccine “is easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

An EUA means that the FDA allows some people to receive the vaccine while the agency continues to analyze data. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. The company is asking the FDA to approve use of the vaccine in people 18 years and older.

NOT A WORD submitted his Covid vaccine data J&J said the level of protection the vaccine provided varies by region. The shot shows an overall effectiveness of 66%, 72% in the USA, 66% in Latin America and 57% in South Africa. Variant B.1.351 spreads quickly. However, FDA staff records indicate that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospital stays and deaths.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

FDA staff approved J & J’s vaccine on WednesdayDocuments state that the clinical trial results and safety data “are in line with recommendations in FDA guidelines on approving the emergency use of vaccines to prevent COVID-19.”

The FDA report found no specific safety concerns for the vaccine when analyzed by age, race, and comorbidity. Were headache, fatigue and muscle pain some of the most common side effects among the people who received the vaccination, the report said. There have also been reports of nausea, fever, and pain at the injection site.

Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The FDA report says there have been some cases of Bell’s palsy, a condition in which half of your face falls off but was “balanced” with the number in the general population. The FDA previously announced that the condition would be monitored in vaccine recipients after flagging it as a potential problem with Pfizer’s shots, and noted that this isn’t necessarily a side effect, but it is worth looking out for.

– CNBCs Hannah Miao contributed to this report.