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CDC recommends vacationers with excessive danger of Covid problems keep away from cruises

CDC recommends travelers with high risk of Covid complications avoid cruises

The Royal Caribbean cruise ship will be seen on the Hudson River in New York City, United States, on August 18, 2021 as the region’s first cruise ship docks back in New York Harbor.

Tayfun Coskun | Anadolu Agency | Getty Images

The Centers for Disease Control and Prevention said Friday that travelers at high risk of serious complications from Covid-19 should avoid cruises regardless of their vaccination status.

The updated guidelines also recommended that travelers who are not fully vaccinated should not cruise.

The new council follows several coronavirus outbreaks reported on board cruise lines, according to the CDC.

While the agency doesn’t introduce the same masking requirements that apply to planes, trains, and other public transportation, it suggested that face-covering be worn for cruise passengers in common areas.

“The virus that causes Covid-19 spreads easily between people in close proximity on board ships, and the likelihood of getting Covid-19 on cruise lines is high,” the CDC said in its updated guidance.

The agency advised all travelers, regardless of their vaccination status, to get tested one to three days before a cruise and three to five days after their return. Anyone taking a cruise should be in quarantine for seven days after returning, even if they tested negative for the virus.

The new policy comes just a week after the Belize Tourism Board announced that 27 people on board a Carnival cruise tested positive for Covid.

During Friday’s extended trading, Carnival Cruises shares fell more than 2%, Norwegian Cruise Line shares fell nearly 3%, and Royal Caribbean Cruises shares fell more than 2%.

After the industry closed at the beginning of the pandemic due to multiple outbreaks on board ships, the CDC has enforced strict guidelines to prevent similar events from occurring.

Of the three cruise lines, Royal Caribbean was the first to return to operations and had few cases on board ships, which was the target, according to CEO and Chairman Richard Fain.

Royal Caribbean and Carnival have allowed some unvaccinated passengers on board ships, but Norwegian has not.

Norwegian even filed a lawsuit against Florida surgeon general to halt a state ban that prevented companies from requiring customers to provide proof of Covid vaccination. The cruise company was granted a temporary stay in enforcement, but Florida has filed an appeal.

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Politics

C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

Dr. Jose U. Scher, a rheumatologist at NYU Langone Health who has studied the effect of vaccines on the immunocompromised, said that the C.D.C. vote — and the guidance from its experts — would help patients who had been agonizing over whether to seek out a third shot. Previously, he said, when people tested themselves for antibodies after vaccination and came up empty, “there were no tools for us to respond to that.”

Updated 

Aug. 13, 2021, 5:00 a.m. ET

“We now know that this population was being left behind,” he said.

Immunocompromised people will not need a doctor’s permission or a prescription to get a third shot, C.D.C. officials said. They will need only to attest that they meet the eligibility requirements for an additional dose. Anyone else, including people with chronic medical conditions, like diabetes or asthma, should not be getting third shots at this point, they said.

Dr. Scher predicted that this honor-system approach could be messy. “I don’t know if there’s any way of corroborating someone’s claim” of being immunocompromised, he said. Requiring some kind of proof, such as a doctor’s note, would be a better process, he said.

The updated F.D.A. authorizations do not apply to immunocompromised people who received the single-dose Johnson & Johnson vaccine. The C.D.C. panel did not offer recommendations on additional shots for that group, which is believed to be small. But the lack of guidance from either the F.D.A. or C.D.C. has left that group in limbo.

Understand the State of Vaccine and Mask Mandates in the U.S.

    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
    • Vaccine rules . . . and businesses. Private companies are increasingly mandating coronavirus vaccines for employees, with varying approaches. Such mandates are legally allowed and have been upheld in court challenges.
    • College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
    • Schools. On Aug. 11, California announced that it would require teachers and staff of both public and private schools to be vaccinated or face regular testing, the first state in the nation to do so. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.  
    • Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
    • New York. On Aug. 3, Mayor Bill de Blasio of New York announced that proof of vaccination would be required of workers and customers for indoor dining, gyms, performances and other indoor situations, becoming the first U.S. city to require vaccines for a broad range of activities. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
    • At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.

“We do understand the challenges here, and because of that we will continue to work very diligently to try to have a solution,” Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said at the panel’s meeting. The F.D.A. is waiting on more data that it expects to receive this month, including Johnson & Johnson’s clinical trial data on the safety and efficacy of two doses.

Dr. Kathleen Dooling, a C.D.C. official, said that patients who qualify for a third dose should ideally seek out the vaccine they already received, but that they could take the other two-dose vaccine if necessary.

Presenting studies that supported giving third doses, Dr. Dooling emphasized that immunocompromised people who receive a third dose should still wear a mask, maintain social distancing with people they do not live with, and avoid crowds and poorly ventilated indoor spaces. She said that people with weakened immune systems had also been shown to be at greater risk of breakthrough infection.

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Health

C.D.C. Recommends Covid Vaccines Throughout Being pregnant

C.D.C. Recommends Covid Vaccines During Pregnancy

Still, many pregnant patients who are reluctant to introduce foreign substances into their bodies want more long-term data and scientific evidence that the vaccines have no effect on the development of the fetus, said Dr. Adam Urato, a Framingham, Massachusetts maternal-fetal medical specialist providing advice to patients about the vaccine.

“The only question my patients ask me all the time is, ‘Are we absolutely sure that these vaccines won’t harm my baby?'” He said.

Tista Banerjee, 32, who gave birth to twins in late June, said she chose not to get vaccinated until after she was pregnant.

“During pregnancy, they say that if you don’t need to take external medication, then you shouldn’t and that you should be extra careful with what you put into your body,” said Ms. Banerjee. The vaccine was still fairly new in April when she was considering vaccinating, she said, and she was lucky enough to be able to work remotely and avoid unnecessary exposure to the virus.

She was fully vaccinated in July, shortly after giving birth, she said.

Pregnant women, who were often excluded from medical trials, were not included in the clinical trials of the Covid vaccines, and the World Health Organization was ambiguous in its guidelines on vaccines, both for breastfeeding women for whom safety data are not available, and for and for pregnant women.

In interim recommendations issued in June, the global health organization said it recommends vaccination “when the benefits of vaccination to the pregnant woman outweigh the potential risks.” Examples were women who are at high risk of exposure to Covid and those with chronic health conditions such as obesity or diabetes who are at higher risk for serious illness.

Sabrina Imbler contributed the reporting.

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Health

Pediatricians Affiliation Recommends Common Masking in Faculties

Pediatricians Association Recommends Universal Masking in Schools

The American Academy of Pediatrics issued new Covid-19 guidelines for schools on Monday recommending that everyone over the age of 2 wear masks in the fall, even if they have been vaccinated. Exceptions can be made for those with medical or developmental conditions that make it difficult to wear masks, the group said.

The universal masking recommendation is a departure from the guidelines issued earlier this month by the Centers for Disease Control and Prevention that only recommend masking in schools for unvaccinated people over the age of 2. These guidelines strongly imply that fully vaccinated children and adults are not required to wear masks in the classroom – although they also said individual schools are free to implement universal masking requirements.

However, in many ways the two directives are similar. The AAP, like the CDC, stressed the importance of returning to personal learning.

“Our priority must be getting children back to school with their friends and teachers – and we are all helping to ensure that it happens safely,” said Dr. Sonja O’Leary, the chair of the AAP Council on School Health, in a statement.

Like the CDC, the AAP recommended a “layered” approach that combines a variety of measures to reduce the risk of coronavirus transmission. In addition to universal masking, these measures include vaccinations, improved ventilation, virus testing, quarantines, and cleaning and disinfection, the group said.

The AAP gave several reasons for its universal masking recommendation.

Many students are too young to be eligible for the vaccines, which are only approved for those aged 12 and over, the group found. And universal masking could reduce overall transmission of the virus and help protect those who are not vaccinated.

The group also cited concerns about more communicable virus variants and the possibility that vaccination rates could be low in the surrounding community, which could increase the risk of an outbreak at a particular school. The AAP also recommended universal masking because it can be difficult to verify that individual students or employees have been vaccinated.

Some state and local officials have already announced that they will not be calling for universal masking this fall, and at least eight states have banned such mandates.

The AAP guideline didn’t stop recommending vaccine mandates, but it said they might ultimately be needed. “It may be necessary for schools to collect Covid-19 vaccine information from staff and students and for schools to require Covid-19 vaccination for personal learning,” the guidelines say.

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Business

CDC recommends pregnant ladies get Covid vaccine after examine reveals it is secure

CDC recommends pregnant women get Covid vaccine after study shows it's safe

A health worker doses the Pfizer-BioNtech COVID-19 coronavirus vaccine to a pregnant woman on January 23, 2021 at Clalit Health Services in the Israeli Mediterranean coastal city of Tel Aviv.

Jack Guez | AFP | Getty Images

The Centers for Disease Control and Prevention recommend Covid-19 shots for pregnant women after preliminary data from the largest study of coronavirus vaccine use in expectant mothers showed that Pfizer and Moderna shocks were effective for both women and men are safe for their babies.

The researchers did not find “obvious safety signals” in any of the 35,691 women followed in the peer-reviewed study published Wednesday by the New England Journal of Medicine. The data used in the study were self-reported and the ages of the participants ranged from 16 to 54 years.

“No safety concerns for third trimester vaccinees or safety concerns for their babies were observed,” said CDC Director Dr. Rochelle Walensky on Friday. “Therefore, CDC recommends pregnant people to receive Covid-19 vaccines.”

Researchers used the V-Safe Post-Vaccination Health Checker monitoring system, the V-Safe Pregnancy Register, and the Vaccine Adverse Event Reporting System to characterize the initial safety of mRNA Covid-19 vaccines in pregnant women.

Pregnant women were more likely to report injection site pain than those who weren’t, but fewer other side effects such as headache, myalgia, chills, and fever. Of the 827 participants who completed their pregnancies, the miscarriage rates were the same as before the pandemic.

The results are preliminary and only cover the first 11 weeks of the US vaccine rollout from December 14th to February 28th.

Pregnant women are more likely to be hospitalized and have a higher risk of death if they become infected with Covid-19. According to CDC data, vaccination is particularly important for this population group. Pharmaceutical companies have not included pregnant women in early efficacy and safety studies, but recent studies suggest that the vaccines are safe for them.

The researchers said “more longitudinal research, including tracking large numbers of women who were vaccinated earlier in pregnancy, is needed to inform mother, pregnancy and child results.”

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Health

CDC panel recommends resuming use

CDC panel recommends resuming use

An advisory panel to the Centers for Disease Control and Prevention on Friday recommended the US resume vaccine from Johnson and Johnson Covid-19, with the benefits outweighing the risk.

Panel members did not recommend U.S. regulators limit use of the vaccine based on age or gender, but suggested that the FDA consider adding a warning to women under the age of 50.

The recommendation, accepted 10: 4 with one abstention by the CDC Advisory Committee on Immunization Practices, will pave the way for US regulators to end their recommended break in the use of the J&J shot earlier this weekend.

The single shot is an important tool for delivering life-saving vaccines to hard-to-reach places where reliable cooling may not be available, e.g. A second dose is given in tribal, poorer areas, and rural communities, and for people who may not be able to return, US health officials say.

The committee, an external panel of experts advising the CDC, decided last week to postpone a decision on the vaccine while officials continued to study cases of six women aged 18 to 48 who had combined cerebral venous sinus thrombosis (CVST ) developed with low platelets within about two weeks of receiving the shot.

The Food and Drug Administration and CDC on April 13 urged states to temporarily suspend use of J & J’s vaccine “out of caution” following reports of the rare blood clots. Within hours of the alert, more than a dozen states, as well as a few national pharmacies, suspended vaccinations with J & J’s vaccine, with some replacing scheduled appointments with either the Pfizer or Moderna vaccine.

Prior to Friday’s vote, the committee debated whether to recommend against J & J’s use of the vaccine or recommend it to U.S. regulators enforcing a warning label. The committee also considered limiting use of the vaccine based on age or other risk factors.

CVST occurs when a blood clot forms in the venous sinuses of the brain. It can prevent blood from draining from the brain and can eventually lead to bleeding and other brain damage. The blood clots are similar to those reported in some people who received the Covid-19 vaccine from AstraZeneca.

During the meeting on Friday, Dr. Tom Shimabukuro, a CDC official, said there have been no reports of the condition of those who received the Pfizer BioNTech mRNA vaccine. There have been three reports of CVST in patients receiving the Moderna vaccine, he said, even though the patients did not have the low platelet levels seen in the J&J recipients.

Platelets help the body form blood clots to heal wounds. US health officials warned against a treatment such as blood-thinning heparin in patients with low platelets, which could make their condition worse.

Rare blood clots with low platelets occur in women aged 18 to 49 at the rate of 7 per 1 million vaccinations for the J&J shot and 0.9 per 1 million in women aged 50 and over. This is evident from a slide presented at the CDC panel meeting. CDC has confirmed a total of 15 cases of rare blood clots, including 12 women who developed blood clots in the brain. Three women have died and seven remained in the hospital, according to slides.

There are no confirmed cases in men, although officials have stated that they are looking at potential additional cases.

Dr. Michael Streiff, a hematologist at Johns Hopkins University Medical School, said the condition is very rare under normal circumstances. “I can tell you from my experience treating these patients that I’ve just never seen it before,” he told the committee during a presentation on Friday.

A CDC model presented at the meeting showed that not resuming use of J & J’s vaccine would delay immunization for all adults who wish to receive the shots by 14 days.

J&J executives told the committee that the vaccine’s benefits still outweighed the risks, adding that the shots would prevent death and hospitalizations. They proposed a new warning label for the vaccine explaining the risk of blood clots.

“We could expect that if 1 million people in the US were vaccinated with the J&J single-dose vaccine, there would be more than 2,000 deaths and 6,000 fewer hospital stays associated with Covid,” said Dr. Joanne Waldstreicher, Chief Medical Officer of J & J.

Earlier this week, J&J announced that it would restart its vaccine rollout in Europe after regulators there backed the single vaccine by recommending adding a warning to the label. The European Medicines Agency has examined all available evidence, including reports from the United States.

Last week, US health officials announced that the hiatus from using the vaccine would only be a few days, depending on what they learned from investigating the cases

Before the CDC meeting, Dr. Wilbur Chen, a member of the committee, told CNBC that he saw “a great amount of evidence” that the benefits of the J&J vaccine still outweighed its risks.

“I think we are ready to use this vaccine. We had to take an important pause to review this safety information in order to consider the risks. But I think there is a great amount of evidence of this to be of benefit that risk far outweighs that, “Chen, a professor at the University of Maryland Medical School, told Worldwide Exchange.

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Health

Airline, journey shares slip after U.S. recommends pause in J&J Covid vaccine

Airline, travel stocks slip after U.S. recommends pause in J&J Covid vaccine

Passengers board an American Airlines flight at Ronald Reagan Washington National Airport in Arlington, Virginia on April 11, 2021.

Andrew Caballero-Reynolds | AFP | Getty Images

Airline and other travel stocks fell Tuesday after U.S. authorities called for a break in using Johnson & Johnson’s Covid-19 vaccine due to rare reports of blood clotting.

The Food and Drug Administration urged states to stop using the single-dose vaccine after six people in the United States developed a rare bleeding disorder after receiving the shot. J&J said that “no clear causal link” was found between the blood clots and the vaccine and that it is working with regulators to assess the problem.

The recommendation comes just as airlines and other travel companies reported an improvement in bookings after coronavirus cases peaked earlier this year and more people were vaccinated.

Delta Air Lines and United Airlines stocks both fell more than 3% in morning trading. American Airlines shares were down about 5%. The Fort Worth-based airline estimated Tuesday that first quarter revenue was 62% lower than in the first quarter of 2019.

American expects a net loss of $ 2.7 billion to $ 2.8 billion for the quarter, excluding state wage support for the sector. The airline said its daily cash use averaged $ 27 million per day for the quarter, including $ 9 million per day in debt and severance payments, down from the previously estimated $ 30 million.

The cruise companies Carnival and Norwegian Cruise Line each gained more than 2%, while Marriott and Hilton both declined more than 1%.

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Business

CDC panel recommends use of J&J’s single-shot Covid vaccine

J&J does not have large inventory of doses, Biden official says

Illustration of the Johnson & Johnson coronavirus vaccine

Given Ruvic | Reuters

An advisory panel to the Centers for Disease Control and Prevention unanimously voted on Sunday to recommend the use of Johnson & Johnson’s one-off Covid-19 vaccine for those ages 18 and older as the federal government prepares to serve millions of doses this week to send .

As soon as CDC director Dr. Rochelle Walensky accepts the recommendation of the Advisory Committee on Immunization Practices, the federal government can begin shipping doses to locations across the country. The ACIP met in an emergency meeting to review the vaccine dates, which took place on Saturday became the third shot to receive emergency clearance from the Food and Drug Administration.

Walensky said Friday that she “would be ready to review the ACIP recommendation” and “be ready to sign”.

“We are very close to having another vaccine in our tool boxes, the Johnson & Johnson Covid-19 Vaccine. Like many of you, I am pleased to hear that another safe and effective vaccine option could be coming as soon as next week “She said Friday. “An additional safe and effective vaccine will help protect more people, faster.”

Dr. Richard Nettles, vice president of medical affairs at J&J, told lawmakers Tuesday that the company was ready to ship nearly 4 million doses once it receives emergency approval. He added that the company expects to have 20 million cans ready by the end of March.

The introduction of the J&J shot could be a boon to the U.S. vaccine supply. While the new vaccine showed signs of being less effective at preventing Covid-19 in clinical trials when compared to Pfizer-BioNTech and Moderna vaccines, the J&J shot was 100% effective at preventing deaths and hospitalizations, caused by Covid-19 in clinical trials.

The level of protection of the J&J vaccine against Covid-19 in studies varied regionally, according to FDA documents released on Wednesday. About a month after inoculation, the shot showed 72% effectiveness in the US, 61% in Latin America and 64% in South Africa, where variant B.1.351 is spreading rapidly.

In particular, the FDA review found the vaccine was significantly less effective in people aged 60 and over who also had comorbidities like diabetes or heart disease. However, the agency found that the data was too sparse for any conclusions to be drawn.

In contrast, in clinical studies, Pfizer’s vaccine has been found to be 95% effective against Covid-19, while Moderna’s vaccine is around 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a head-to-head comparison with the other two vaccines because it is a single dose and the company’s study was conducted when more infections, as well as new, more contagious variants occurred.

However, federal health officials have indicated that the one-off J&J regime offers unique logistical benefits that could make it ideal for hard-to-reach populations.

J & J’s vaccine “makes it 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.”

J&J has announced that it will ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine typically has to be stored in ultra-cold freezers, which are between minus 112 and minus 76 degrees Fahrenheit. However, the FDA recently announced that it could be stored in pharmacies for up to two weeks at standard freezing temperatures. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.

– CNBC’s Berkeley Lovelace contributed to this report.

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Health

FDA panel unanimously recommends emergency use

FDA panel unanimously recommends emergency use

A key advisory body to the Food and Drug Administration unanimously endorsed Johnson & Johnson’s emergency single-shot coronavirus vaccine on Friday. This is a critical step that paves 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 on Friday that the decreases in Covid-19 cases reported in the US since early 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 “isn’t getting close” to herd immunity, but vaccination may 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. At a similar request from Pfizer and Moderna, the FDA approved these companies’ vaccinations the day after the committee endorsed approval for emergency use. 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 doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature 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.

J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. 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 officials on Wednesday approved J & J’s vaccine and stated in documents that the clinical trial results and safety data “are in line with recommendations in the FDA’s 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. Headache, fatigue, and muscle pain were some of the most common side effects in 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.

CNBC’s Hannah Miao contributed to this report.

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Entertainment

Love Classical Music? Anthony Tommasini Recommends Modern Composers

Love Classical Music? Anthony Tommasini Recommends Contemporary Composers

Gilbert asks: I have to say when I hear you describe these performances I miss the size of a concert hall as much as I miss the size of a movie screen. Part of experiencing art outside of my home is the potential to be overwhelmed, and as many speakers I have or as big as my TV, it obviously doesn’t feel that way. I’ve only really started watching live classical music in the last three or four years. You have been doing this for much longer and I have to imagine that the longing is deeper.

You recently wrote a wonderful piece, Notes Toward Reinventing the American Orchestra, which is full of clever suggestions on how classical music organizations could change after the pandemic. What don’t you want to change

Tony replies: Ah, what I don’t want to change about classical music, which in my opinion will never change, is the pure sensual pleasure, even ecstasy, in the sound of a large orchestra, a fine string quartet, a radiant soprano. And to experience that you have to experience this art form live.

As a child I got to know countless pieces through recordings. And during the pandemic, it often feels like we just have recordings. When I was growing up, I was enthusiastic about the pianist Rudolf Serkin and the New York Philharmonic under Bernstein in the Carnegie Hall in Beethoven’s mighty “Emperor” concert. and as a young teenager having a standing ticket to hear the famous soprano Renata Tebaldi in her voluptuous voice as Desdemona in Verdi’s “Otello” at the Metropolitan Opera; or a little later, when I hear Leontyne Price’s soft, sustained high notes rise up in “Aida” and surround me on a balcony seat in the Met. I only vaguely knew what these operas were about. I didn’t care.

And what I say also applies to more intimate music. Only when you hear a great string quartet performing works by Haydn, Shostakovich or Bartok in a hall with only a few hundred seats do you really understand what makes “chamber music” so overwhelming. But hearing a symphony by Mozart or Messiaen in a lively, inviting concert hall makes a big difference.

Gilbert asks: You’ve proven this to me several times over the past three years – I think about the time it took you to listen to “The Rite of Spring” at Carnegie Hall and I walked out amazed. (I know, such a newbie.) Or when my eyes flashed at the end of Samuel Barber’s “Knoxville Summer 1915” at David Geffen Hall. I just don’t think I would have had the same feelings if I’d heard these pieces at home.