FDA Panel to Vote on First RSV Vaccine Given in Pregnancy to Protect Infants

THURSDAY, May 18, 2023 (HealthDay News) — The first RSV vaccine designed to protect infants is under consideration by a panel of advisers to the U.S. Food and Drug Administration.

An independent committee of experts will vote Thursday on whether to recommend the shot for pregnant mothers at 24 to 36 weeks gestation.

“Before the pandemic, RSV was the No. 1 cause of infant hospitalization in the United States, so this is a big deal,” Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, told NBC News. Levy is a temporary voting member of the panel, but not one who will vote on this vaccine.

If the panel recommends the vaccine, the FDA would still need to approve it, a process that could take months. The agency is not obligated to follow its advisers’ recommendations, but it usually does.

The Pfizer-made vaccine would only be the second one ever approved in the United States for RSV (respiratory syncytial virus). A vaccine made by pharmaceutical company GSK was approved for adults ages 60 and up earlier this month. However, 11 RSV vaccines for various age groups are being tested in ongoing clinical trials.

When a mother-to-be receives the vaccine, protective antibodies transfer to infants through the placenta.

Safety data for the infant vaccine is “generally favorable,” according to the FDA. 

Trial participants had a slightly elevated rate of preterm births compared to the control group, according to the news report. However, that rate was still lower than that seen in the general population. The rate of preterm births among the 7,400 trial participants was 5.7% for those who received the vaccine compared to 4.7% of those who received a placebo and 10% in the general population. A trial by GSK for an infant vaccine was halted last year because of a higher preterm birth rate.

RSV generally causes mild, cold-like symptoms. It is a minor illness in healthy adults, but can be severe in more vulnerable groups, including babies and older adults.

Up to 300 children younger than 5 years die from RSV in the United States each year. Up to 10,000 people age 65 and older also die from the virus, according to the U.S. Centers for Disease Control and Prevention.

In a clinical trial for the vaccine, infants had an 82% lowered risk of severe disease in the first three months after birth, NBC News said. That dropped to 69% by six months. Infants also had 51% lowered risk of developing respiratory disease so severe that it required a doctor’s visit.

“Maternal immunization looks like an important piece of the puzzle, but we’re going to need more to shield into the second half of the first year [of infancy] and beyond,” Levy said.

Vaccines given in pregnancy are always concerning, he said.

“There’s always the background concern: Are you inducing some inflammation that could be a problem? Because the body reads inflammation as, ‘The woman’s no longer safe, let’s get the baby out.’ So you want a fairly bland vaccine,” Levy said.

Pfizer also has a proposal for an RSV vaccine used by older adults before the FDA panel this month. That is for the same vaccine, but for use in people ages 60 and up.

Another option, a monoclonal antibody injection, has already been approved in Canada, Europe and the United Kingdom for infants. An application for that shot is also being reviewed by the FDA. 

Vaccine side effects including fatigue, headache, muscle pain and injection site pain in pregnant women.

More information

The U.S. Centers for Disease Control and Prevention has more on RSV.


Seven questions to ask during well-child checkups

Following the recommended schedule for well-child visits can help protect your child’s long-term health and well-being. These appointments also give you an opportunity to talk to your pediatrician about growth, development, and behavior.

Here are seven questions to help you get the most out of your appointments:

1. Is my child growing and developing at a healthy rate?

At each visit, your pediatrician will measure your child’s height and weight. Babies and toddlers often experience rapid growth, while gaining too much weight may be an issue for older children and teens.

2. Are my child’s vaccines up to date?

Recommended vaccinations protect children from serious diseases, including hepatitis, measles, tetanus, and polio. It’s important to get vaccines on schedule because sometimes it can take multiple doses before a child is fully protected. Make sure you understand what each vaccine protects against, and remember that children age six months and older should receive an annual flu shot.

3. What foods and beverages should my child eat?

Good nutrition is essential for healthy growth and development. For babies and toddlers, you might have questions about breastfeeding or when to introduce solid foods. As children grow up, it’s important to establish healthy eating habits. Ask your doctor about foods and beverages your child should avoid and what to do if you have a picky eater.

4. How can I keep my child safe?

Talk to your pediatrician about steps you can take to child-proof your home, protect kids from exposure to the sun, and protect against infectious diseases. Depending on the age of your children, you might have questions about when it’s time to graduate from a car seat or how much screen time is appropriate.

5. Do you have any concerns about my child’s mental health?

Mental health is important at every age. Whether your child is struggling at school or having trouble making friends, identifying an issue gives your pediatrician a chance to address it. Depression and anxiety are common among children and adolescents, so don’t be afraid to bring up these issues.

6. Ask about any specific concerns you have.

Make a list of your questions before the appointment, and put the most important ones at the top. That way, you won’t forget to ask about something that has been on your mind.

7. When should I schedule our next well-child visit?

Book your next appointment before you go home. You can change the date later, if needed, but scheduling your next visit while you’re at the doctor’s office can help you stay on track.

Text neck: How to avoid neck pain when using your mobile phone

We spend a lot of time on our mobile phones these days, sending texts, checking email, and accessing the web. Looking down at a phone for long periods of time can put added stress on the muscles in the neck, resulting in chronic pain known as text neck. Following a few simple tips can help you improve your posture and prevent pain and stiffness in your neck.

Your mobile phone may be causing your neck pain

On average, Americans spend almost three hours on their mobile devices each day, texting, playing games, checking email, watching movies, and accessing the internet. All of that time adds up to about 44 days per year.

When you look down at your mobile phone and tilt your head forward, it changes the natural curve of your neck and causes the muscles in your neck and back to become fatigued. In addition, your back becomes rounded and your shoulders roll inward. Over time, this can lead to the development of early osteoarthritis in the spine—a condition called text neck.

What is text neck?

Text neck is a repetitive stress injury caused by prolonged use of a mobile phone, tablet, or handheld electronic device. While text neck is not an official medical diagnosis, it refers to the symptoms a growing number of people experience due to overuse of their mobile devices.

The condition is associated with texting, but any activity you do a phone or tablet while looking downward, such as playing a game or responding to email, can result in poor posture and cause trauma to the soft tissues in the neck.

How does text neck cause pain?

A mild ache in the neck or upper back is often the first sign of text neck. In some cases, it causes a sharp pain or stiffness in the neck. Pain is your body’s way of telling you that something isn’t right.

Other symptoms of text neck include:

  • Neck pain
  • Shoulder pain
  • Back pain
  • Headaches
  • Numbness, tingling, or burning in the arms

Left untreated, text neck can lead to more pain and reduced mobility in the neck, upper back, and shoulders.

More teens show signs of text neck pain

Text neck is of particular concern among teenagers and young adults whose spines are still developing. Doctors and chiropractors have seen an increase in neck pain and poor posture among young patients due to frequent use of mobile devices. Researchers continue to study the link between long-term neck pain and the overuse of mobile devices.

Tips to prevent text neck and relieve neck pain

1. Check your posture in a mirror. When you stand with good posture, you should be able to draw a vertical line from your ear to your shoulder.

2. Minimize the bend in your neck. Rather than looking down at your mobile phone, raise it to eye level and look forward. Avoid using a tablet on your lap, and instead prop it up with a pillow. This will reduce the stress on the muscles in your neck and upper back, causing less pain.

3. Limit your device use to 20-minute sessions. Keep text messages short on mobile devices and use a computer for longer messages. If you’re planning to have a long conversation, use the hands-free function on your phone.

4. Stretch your muscles. Ask your doctor or healthcare provider to recommend exercises to improve your posture and strengthen your shoulders, neck, and back.

5. Take breaks. Pay attention to how much you use your phone. Remember to take breaks, and try using it for shorter periods of time.

Another Study Links ‘Ultra-Processed’ Foods to Higher Cancer Risk

food processed junk
WEDNESDAY, Feb. 1, 2023 (HealthDay News) — Fizzy sodas, microwaveable meals and packaged cookies are convenient for people on the go, but these folks might not go as far as they’d like if that’s all they eat.

Ultra-processed foods appear to increase the risk of developing and dying from a variety of cancers, a new large-scale study says.

Every 10% increase of these foods in your diet increases your overall risk of cancer by 2% and your risk of a cancer-related death by 6%, researchers reported Jan. 31 in eClinical Medicine.

The risk is even higher for specific cancers, particularly those that primarily affect women.

For example, every 10% increase in a woman’s consumption of ultra-processed foods makes her 19% more likely to develop and 30% more likely to die from ovarian cancer, the investigators found.

The researchers describe ultra-processed foods as “industrial formulations made by assembling industrially derived food substances and food additives through a sequence of extensive industrial processes.”

Industrially derived ingredients include things like high-glucose corn syrup, modified starch, protein isolates, emulsifiers, stabilizers and preservatives, the study authors said.

“Our bodies may not react the same way to these ultra-processed ingredients and additives as they do to fresh and nutritious minimally processed foods,” lead researcher Kiara Chang, a research fellow with Imperial College London’s School of Public Health, said in a college news release.

“However, ultra-processed foods are everywhere and highly marketed with cheap price and attractive packaging to promote consumption,” Chang continued. “This shows our food environment needs urgent reform to protect the population from ultra-processed foods.”

Ultra-processed foods make up 57% of the average American’s daily calories, up from 53% in 2001, noted Marjorie McCullough, senior scientific director of epidemiology research at the American Cancer Society.

For this study, Chang and her colleagues analyzed records for nearly 200,000 participants in the UK Biobank, an ongoing health study of people in England, Scotland and Wales.

Part of the Biobank research involved people filling out questionnaires regarding their diet. Records also were kept on who developed and died from 34 types of cancer.

The researchers tracked participants for 10 years and found out that the more people chowed down on ultra-processed foods, the higher their risk of cancer.

This could be because highly processed foods are calorie-dense and therefore are more likely to make a person fat, McCullough said. “Eating highly palatable ultra-processed foods is linked to excess body weight, itself a risk factor for at least 13 cancer types,” McCullough said. “These foods are usually higher in sugar, refined grains and fat, and may impact metabolism differently than whole, unprocessed or minimally processed foods.”

These foods — and their packaging — also contain loads of chemicals that could contribute to cancer risk, said Dr. Emanuela Taioli, co-leader of the Cancer Prevention and Control Program at Mount Sinai’s Tisch Cancer Institute, in New York City.

“They are treated with preservatives, with chemicals that preserve their freshness. And most of the time, they are in containers that are plastic or other material that is known to be one of these environmental cancer risks from endocrine disruptors,” Taioli said. “Then when they are warmed up, we don’t really know what happens to the chemistry of the preservatives, which with the heat can become other compounds that are carcinogens.”

The presence of endocrine-disrupting chemicals like BPA and PFAS could explain, in particular, the increased risk in women’s cancers, Taioli said.

“These compounds modify hormone patterns or behave as hormonal,” Taioli said. “The body sees more hormones because these chemicals look like hormones, so they affect cancers that are very hormone-sensitive. From these results it seems like the role of endocrine disruptors should be explored further.”

Excess fat is also a known risk factor for both breast and ovarian cancer, McCullough said.

To lower their cancer risk, as well as their risk of heart disease and other ailments, people should opt for fresh foods as much as possible, McCullough and Taioli said.

“The American Cancer Society recommends following a healthy diet that includes a variety of colorful vegetables and whole fruit, fiber-rich legumes, whole grains and limiting or not including red and processed meat, sugar-sweetened beverages and highly processed foods and refined grains,” McCullough said.

Nations should take steps to protect their citizens from the health effects of these foods, Chang said, urging the use of front-of-pack warning labels for ultra-processed foods to aid consumer choices.

More information

The U.S. National Institutes of Health has more about the cancer risk from obesity.

SOURCES: Kiara Chang, MSc, research fellow, Imperial College London’s School of Public Health; Emanuela Taioli, MD, PhD, co-leader, Cancer Prevention and Control Program, Mount Sinai’s Tisch Cancer Institute, New York City; Marjorie McCullough, ScD, RD, senior scientific director, epidemiology research, American Cancer Society; eClinical Medicine, Jan. 31, 2023, online  

1 in 5 Young Women Has No Plans to Get a Mammogram

Consumer news
THURSDAY, Sept. 29, 2022 (HealthDay News) — Terlisa Sheppard knows the value of tracking changes in her body.

The Orlando Health patient was eight and a half months pregnant and just 31 years old when she felt a lump under her arm. She left work to get it checked out and “didn’t return back to work because that is the evening that I found out I had breast cancer,” Sheppard said.

Now, 23 years later — and long after delivering that healthy baby — Sheppard wants young women to understand the benefits of screening for breast cancer.

“I know for sure that that mammogram saved my life and my baby’s life,” Sheppard said.

Early detection of breast cancer is critical to help women avoid a late-stage diagnosis that is harder to treat. Yet a new survey finds many younger women have no plans to get a mammogram in the near future.

Researchers also found that many of these women are unaware of their individual risks for breast cancer. 

The national survey by a health provider in Florida found that more than one-fifth — 22% — of women 35 to 44 had no plans to get a mammogram that could detect cancer and potentially save their lives.

“That to me is really concerning because we recommend mammograms starting at age 40 and these women are saying, ‘Nope, I don’t plan to,'” said Dr. Nikita Shah, medical oncology team leader for the Breast Cancer Center at the Orlando Health Care Institute. The survey of more than 1,100 adult women was conducted online Sept. 8-12. 

Breast cancer specialists at Orlando Health aren’t sure why women might feel this way. But Shah believes it’s a combination of lack of awareness, concerns about the cost of a mammogram and worries that the screening procedure will hurt.

While cost can be a factor for some, most private insurers cover screening mammograms under the Affordable Care Act. Also, during October, which is Breast Cancer Awareness Month, many organizations offer them for free or at a low cost, such as $20 to $30, Shah said. 

“The other thing I hear is the compression hurts and, yes, it does hurt, it’s a little uncomfortable, but it literally lasts for a few minutes and then it goes away,” Shah said. “Don’t let that be a reason why you don’t do a mammogram, which can save your life.”

Women of average risk of breast cancer can get a mammogram annually beginning at age 40, according to guidelines. Those who have a family history of breast cancer should start earlier as should those with prior biopsies, atypical cells and dense breast tissue. While 22% of women ages 35 to 44 have never had a mammogram and have no plans to get one, only about 43% of women knew their family history, the survey found.

“We kind of just assume that people know, but sometimes patients don’t have good relationships with family members or they don’t know or they don’t ask or people may not talk about it,” Shah said. “Knowing family history is important.”

About 42,000 women in the United States die of breast cancer each year, according to the U.S. Centers for Disease Control and Prevention, but survival is over 90% if the tumor is caught early. Mammograms can spot tiny tumors, making it more likely to catch the disease at an earlier stage.

Orlando Health recommends women talk with their primary care physician or gynecologist beginning in their 20s to help assess their risks. The health organization also recommends monthly self-exams to feel for any changes.

The risks for women are not uniform, and Black women are 40% more likely to die from breast cancer compared to whites. This may be in part because Black women often are diagnosed with a more aggressive type of cancer. Social biases may also play a role, Shah said, including possibly delays in initial diagnosis and in treatment.

Susan Brown, senior director of health information and publications at cancer resource organization Susan G. Komen, said the reasons for disparities in outcomes by race aren’t fully known. 

“We think it may be related to the biology of breast cancer. Black women are more likely to have an aggressive form of breast cancer,” Brown said. “They’re also more likely to be diagnosed at a younger age. Then there are also questions about the quality of health care that Black women receive.”

Brown expressed disappointment at the survey results, but not surprise.

“That tells me that we have more work to do to provide some education so that women understand that finding breast cancer early and getting effective treatment if it is diagnosed has been shown to save lives,” she said. “We’ve had mortality decrease because of early detection and effective treatment from 1989 to 2019.”

Mammograms are a widely available tool, Brown said. “I think we have an opportunity to try to just reinforce that message that mammograms today are the best tool we have for finding breast cancer early,” she said.

When cancer is found early and confined to the breast, the five-year relative survival rate is about 99%, Brown said.  However, “if it’s found later, obviously the treatments are more difficult, the side effects are more difficult, the costs are greater and the outcomes are poorer,” Brown said. 

Shah pointed out that about 1% of breast cancers happen in men, and so they should also be familiar with what’s normal in their bodies. 

“If they feel a lump or nipple discharge, don’t ignore it. That’s not normal,” Shah said. “They need to also have it looked at if they feel something.”

More information     The U.S. Centers for Disease Control and Prevention has more on breast cancer.   SOURCES: Nikita Shah, MD, medical oncology team leader, Breast Cancer Center, Orlando Health Care Institute, Florida; Susan Brown, MS, RN, senior director, health information and publications, Susan G. Komen, Dallas, Texas; Terlisa Sheppard, Orlando Health patient; Orlando Health survey, Sept. 8-12, 2022  

What Is Monkeypox, and How Worried Should Americans be?


Consumer news MONDAY, May 23, 2022 (HealthDay News) —

A worrisome international outbreak of monkeypox, a less harmful cousin of the smallpox virus, has now reached the United States and Canada. As of Saturday, 92 confirmed cases of the illness, and 28 more suspected cases, have been reported across 12 countries, according to the World Health Organization.

Between 1 and 5 confirmed cases are currently under investigation in the United States, WHO said. 

Monkeypox was first seen in the United Kingdom, Portugal, Spain and other parts of Europe in early May. On Friday, the U.S. Centers for Disease Control and Prevention was monitoring six people in the United States for possible infection. They sat near to one infected traveler on a flight from Nigeria to the United Kingdom in early May. 

CDC officials are also investigating a confirmed case of monkeypox in a Massachusetts man who recently traveled to Canada, according to CNN. And the New York City Health Department is probing a possible infection in a patient at Bellevue Hospital there.

Despite all of these recent infections in areas where the virus is uncommon, and newfound concern that the disease may spread through sexual contact, health experts are warning against overreacting. Unlike newly emerging diseases like COVID-19, monkeypox is well understood and effective treatments are available.

“Nobody should be panicking,” said Anne Rimoin, chair of infectious diseases and public health at the University of California, Los Angeles. “Monkeypox is a known virus that is being introduced into a new population.”

The illness begins with fever, swollen lymph nodes and other flu-like symptoms, followed by a telltale rash on the face that spreads to other areas, including genitals, hands and feet.

Sexual transmission a possibility

The symptoms are similar to those of smallpox but milder, Rimoin said. 

“It can last for several weeks, and people can feel fairly ill,” she said. Effective treatments are available, however. Monkeypox is primarily spread from animals to humans — and less often from person to person because close contact with bodily fluids is needed, added Hannah Newman, director of epidemiology at Lenox Hill Hospital in New York City.

“Anyone experiencing an unusual rash or lesion and who has risk factors [or had sexual encounters with someone who has] should seek care immediately,” she said.

Many of the newer cases worldwide have occurred among gay and bisexual men.

On Monday Enrique Ruiz Escudero, senior health official in the Spanish capital of Madrid, said the city has recorded 30 confirmed cases of monkeypox so far. He said authorities are investigating potential links between a recent Gay Pride event in the Canary Islands, which drew some 80,000 people, and cases at a Madrid sauna.

According to Newman, “it appears that there may be a sexual transmission component to the current outbreak, which we haven’t seen in previous outbreaks.” Gay or bisexual men may be at special risk during the current outbreak, she noted.

However, “I feel like this is a virus we understand, we have vaccines against it, we have treatments against it, and it’s spread very differently than SARS-CoV-2 (the virus that causes Covid-19),” Dr. Ashish Jha, the White House Covid-19 response coordinator, told ABC News on Sunday. 

“It’s not as contagious as Covid. So I am confident we’re going to be able to keep our arms around it,” Jha said. “But we’ll track it very closely and use the tools we have to make sure we can continue to prevent further spread and take care of the people who get infected.”

New questions

Risk factors for past outbreaks included contact with live or dead animals and consumption of wild game or bush meat from wild animals, Newman said.

Once the virus jumps from an animal to a human, human-to-human transmission can occur through direct contact with respiratory droplets, bodily fluids or skin lesions.

In Africa, anywhere from 1% to 15% of people with monkeypox will die from the virus. “Severe disease and [death] is higher among children, young adults, and immunocompromised individuals,” Newman said.

The virus was first discovered in 1958 when two outbreaks of a pox-like disease occurred in monkeys. The first known human case occurred in 1970 in the Democratic Republic of the Congo, and it has since been reported in humans in other central and western African countries, according to the CDC.

While it does not occur naturally in the United States, this is not the first time monkeypox has been seen in the nation. A 2003 outbreak was linked to infected prairie dogs imported as pets.

Many questions about the new outbreak remain. 

“We need to monitor it and understand how it is behaving and how it has been introduced into the new population,” Rimoin said. This outbreak appears to be linked to the West African strain of monkeypox, which Rimoin said is less transmissible and tends to cause milder symptoms than the central African strain. 

“Once these details become available, we will know a lot more,” she said.

The outbreak isn’t totally surprising, she added. In recent years, cases of once-eradicated smallpox virus have also popped up. 

“It is not surprising that we see other poxviruses occurring through the world as a result,” Rimoin said.

Vaccines already here

Fortunately, the smallpox vaccine can protect people from monkeypox. 

In fact, the U.S. government has already placed a $119 million order for the vaccine with an option for more. British health authorities are offering smallpox shots to some health care workers and others who may have been exposed to monkeypox.

The good news is that outbreaks of monkeypox are rare and usually short-lived, Newman said.

The 2003 U.S. outbreak, for example, was quickly contained through extensive testing, deployment of smallpox vaccine and treatments, and guidance for patients, health care providers, veterinarians and other animal handlers. 

“All 47 people recovered, and none of the 47 cases spread the illness to another person,” she said.

Cases of monkeypox had previously been seen only among people with links to central and West Africa, according to the Associated Press. But in the past week, the United States was among seven countries reporting infections, mostly in young men who hadn’t previously traveled to Africa.

France, Germany, Belgium and Australia confirmed their first cases on Friday, the APreported.

“I’m stunned by this. Every day I wake up and there are more countries infected,” said virologist Oyewale Tomori, who sits on several World Health Organization advisory boards. 

“This is not the kind of spread we’ve seen in West Africa, so there may be something new happening in the West,” he told the AP.

More information   The U.S. Centers for Disease Control and Prevention has more on monkeypox.   SOURCES: Hannah Newman, MPH, director, infection prevention, Lenox Hill Hospital, New York City; Anne Rimoin, PhD, MPH, professor, epidemiology, and director, Center for Global and Immigrant Health, University of California, Los Angeles; Associated Press, May 20, 2022; CNN, May 20, 2022   


COVID-19 Vaccine Booster

When can I get a COVID-19 vaccine booster? Not immediately. The goal is for people to start receiving a COVID-19 booster shot beginning in the fall, with individuals being eligible starting 8 months after they received their second dose of an mRNA vaccine (either Pfizer-BioNTech or Moderna). This is subject to authorization by the U.S. Food and Drug Administration and recommendation by CDC’s Advisory Committee on Immunization Practices (ACIP). FDA is conducting an independent evaluation to determine the safety and effectiveness of a booster dose of the mRNA vaccines. ACIP will decide whether to issue a booster dose recommendation based on a thorough review of the evidence. 

If we need a booster dose, does that mean that the vaccines aren’t working? No. COVID-19 vaccines are working very well to prevent severe illness, hospitalization, and death, even against the widely circulating Delta variant. However, with the Delta variant, public health experts are starting to see reduced protection against mild and moderate disease. For that reason, the U.S. Department of Health and Human Services (HHS) is planning for a booster shot so vaccinated people maintain protection over the coming months.

Source: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html

For more information see links below: 

High Option: Go here
Consumer Driven Option: Go here or our COVID-19 Resource Center

FDA Review Finds J&J COVID Vaccine Safe, Effective

WEDNESDAY, Feb. 24, 2021 (HealthDay News) — A single-shot coronavirus vaccine made by Johnson & Johnson completely prevented hospitalizations and deaths in a large clinical trial, a new review released Wednesday by the U.S. Food and Drug Administration found.

What would be the third vaccine to be authorized in the United States for emergency use could be approved as soon as this weekend, the Washington Post reported. The J&J vaccine was more than 85 percent effective at preventing severe illness, including in a region dominated by a concerning variant, but only 66 percent protective overall when moderate cases were included.

FDA scientists found the “known benefits” of the vaccine included reducing the risk of symptomatic and severe cases of COVID-19, at least two weeks after vaccination. The review found its efficacy against severe illness “was similarly high across the United States, South Africa, and Brazil.”

“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,” Nancy Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry, told the Post. “Those facts are the most important thing to recognize.”

The vaccine was less effective in a subgroup of adults older than 60 who also had risk factors for severe illness, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines. Overall, there were seven deaths in the trial, all in the group that received a placebo shot, the Post reported.

An FDA advisory panel is set to meet Friday to recommend whether the FDA should authorize the shot for emergency use. 

Public health officials have eagerly awaited the arrival of the J&J vaccine because it can be stored in a refrigerator for several months, which should ease the challenges of distributing vaccines in sub-zero temperatures, and it doesn’t require a follow-up booster shot, the Post said.

Pfizer, Moderna say big jump in vaccine supply coming.

Officials from both Pfizer and Moderna delivered reassuring news about their COVID-19 vaccines to Congress on Tuesday: There will be a sharp rise in the delivery of doses in the coming month, and they will be able to provide enough doses to vaccinate most Americans by summer.

By the end of March, Pfizer and Moderna expect to have delivered a total of 220 million vaccine doses to the U.S. government, a significant uptick from the roughly 82 million doses that the U.S. Centers for Disease Control and Prevention says have shipped so far.

“We do believe we’re on track,” Moderna President Stephen Hoge told a House subcommittee after describing how the company has ramped up production. “We think we’re at a very good spot.”

That encouraging news comes as federal regulators plan to weigh the emergency use of a third COVID-19 vaccine, from Johnson & Johnson, later this week. The Biden administration said Tuesday that it expects about 2 million doses of that vaccine to be shipped in the first week after approval, and the company told lawmakers it should provide enough of the single-dose option for 20 million people by the end of March, the Associated Press reported.

By summer, Pfizer and Moderna said they expect to complete delivery of 300 million doses each, while J&J aims to provide an additional 100 million doses. That would be more than enough to vaccinate every American adult, the AP reported.

Two other manufacturers, Novavax and AstraZeneca, have vaccines in the pipeline and anticipate eventually adding to those totals, the AP said.

When asked whether they face shortages of raw materials, equipment or funding that would delay vaccine deliveries, all of the companies testified that they had enough supplies and had already addressed some early bottlenecks in production.

“At this point, I can confirm we are not seeing any shortages of raw materials,” said Pfizer’s John Young.

The U.S. vaccination campaign continues to accelerate after a sluggish start and recent disruptions caused by a series of brutal winter storms. But state health officials say demand for shots still outstrips the weekly shipments they are given by the federal government.

“The most pressing challenge now is the lack of supply of vaccine doses,” Rep. Diana DeGette, a Colorado Democrat, said as she opened the subcommittee hearing. “Some of the companies here today are still short of the number of doses they promised to initially deliver when they last testified before this subcommittee in July.”

Even with no further interruptions, other issues could still delay or block the United States from vaccinating 70% to 80% of its population — the critical threshold needed to neutralize the spread of coronavirus — by summer.

As of Wednesday, more than 65 million people had received at least one dose of a COVID-19 vaccine, including 19.8 million people who have received both doses, according to the CDC.

U.S. Sees 500,000 COVID deaths

President Joe Biden marked the once unthinkable milestone of half a million Americans lost to coronavirus with a somber, candlelit ceremony at the White House on Monday night.

“The people we lost were extraordinary,” Biden said. “They span generations. Born in America, immigrated to America. But just like that, so many of them took their final breath alone in America.”

The nation’s coronavirus death toll is now higher than in any other country in the world. It has surpassed early predictions of loss by some federal experts, and more Americans have died from COVID-19 than did on the battlefields of World War I, World War II and the Vietnam War combined, The New York Times reported.

The United States now accounts for about 20 percent of the world’s known coronavirus-related deaths, but makes up just 4.25 percent of the global population, the Times reported.

About 1 in 670 Americans has died of COVID-19, and it has become a leading cause of death in the country, along with heart disease and cancer, the Times said. The pandemic has also driven down life expectancy more drastically than seen in decades.

During the early days of the pandemic, Dr. Anthony Fauci, the nation’s top infectious disease expert, and Dr. Deborah Birx, the official coordinating the coronavirus response at the time, projected that even with strict stay-at-home orders, the virus might eventually kill as many as 240,000 Americans — a number that seemed unimaginable at the time.

Less than a year later, the virus has killed more than twice that number. It has spread to every corner of America, decimating both densely populated cities and rural counties.

In New York City, more than 28,000 people have died of the virus — or roughly 1 in 295 people. In Los Angeles County, the toll is about 1 in 500 people, the Times reported. In Lamb County, Texas, where 13,000 people live scattered across 1,000 square miles, the loss is 1 in 163 people.

The virus has torn through nursing homes and other long-term care facilities, which account for over 163,000 deaths, roughly one-third of the country’s death count.

Minorities have suffered far more than others during the pandemic: the coronavirus death rate for Black Americans has been almost two times higher than it is for white Americans, 2.3 times higher for Hispanics than for white Americans; and 2.4 times higher for Native Americans, the Times reported.

More information The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.     SOURCES: Associated Press; Washington Post; The New York Times; CBS News; CNN

COVID-19 Vaccines: Experts Answer Your Questions

WEDNESDAY, Dec. 9, 2020 (HealthDay News) — Two new COVID-19 vaccines, developed at record-setting speed, are soon to be assessed by U.S. agencies for emergency use in combating the ongoing pandemic.

Advisory panels of infectious disease experts this week will assess a vaccine developed by pharmaceutical company Pfizer and German biotech firm BioNTech — a vaccine that Britain began administering to its most vulnerable citizens on Tuesday. The committees will then turn their attention next week to a second vaccine developed by Moderna. Approval of either or both vaccines will begin the largest vaccination effort ever undertaken. The transition from hazy lab science to a very real vaccine-laden needle raises many questions for Americans. But experts have some answers:

When will the first Americans get their vaccines?
U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention advisory committees will review the Pfizer-BioNTech vaccine this week, and if the nod is given then the vaccine rollout could commence at startling speed, said Dr. William Schaffner, a professor of infectious disease with the Vanderbilt University Medical Center in Nashville, Tenn. “It could well be that the first people to get the vaccine could be within the next week or week and a half,” Schaffner said. Because Operation Warp Speed paid manufacturers to start producing doses even as their vaccine candidates underwent clinical trials, there will be stockpiles of both the Pfizer-BioNTech and Moderna vaccines that are ready to ship the second the green light is given, Schaffner said. Warp Speed paid Pfizer nearly $2 billion to manufacture and deliver 100 million doses, and Moderna received about $1.5 billion for 100 million doses of its vaccine. “We’ve stored a lot of vaccine already. It’s one of the reasons we were able to move so quickly. We didn’t wait until the trials were completed to start making and storing the vaccine,” Schaffner said.

Who’s in charge of distributing the vaccine?
Operation Warp Speed and the CDC will oversee national distribution of the vaccine, working in conjunction with the pharmaceutical companies, Schaffner said. However, each state’s health department will identify the specific locations that will receive the vaccine prior to individuals receiving their inoculation, Schaffner said. Because the first two vaccines are based on highly fragile messenger RNA (mRNA), they need to be kept frozen at extremely low temperatures. “The Pfizer vaccine has to be kept so cold, almost minus 100 degrees Fahrenheit, in really deep freeze, otherwise it begins to degrade,” Schaffner said. “It will be going to a relatively small number of institutions, usually hospitals, where they have the facilities to deal with that and they have personnel who can be trained to administer the vaccine.” Upcoming vaccine candidates produced using more traditional methods are expected to be more hardy, and those likely will be distributed directly to pharmacies and the offices of participating physicians, Schaffner said.

How quickly can the vaccine be produced?
One advantage of the mRNA vaccines produced by Pfizer-BioNTech and Moderna is that they are fully lab-manufactured, said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “It’s a synthetic molecule. You just make it in the lab. You don’t have to worry about growing it up in cells, as is true for more classic vaccines,” Offit said. Because of this, Offit is hopeful that large amounts of these vaccines can be quickly churned out. “The Pfizer vaccine is a 30-microgram dose. A microgram is a millionth of a gram. You can make kilograms of this stuff,” Offit said.

However, there are 7.8 billion people in the world. Even with manufacturers working at a fast clip, it will take months to produce two doses for every adult on the planet. And the United States will have to wait in line with other nations competing for the same resource. Pfizer has told the Trump administration that, because other countries have rushed to buy up most of its supply, substantial additional doses above the 100 million the U.S. government purchased earlier this year will not be available to the United States until late June or July, the Washington Post reported Tuesday. Other vaccine candidates receiving approval in subsequent months could speed up efforts to immunize everyone, but at this point it’s not clear how soon those will receive their turn at bat. U.S. officials expect to have about 40 million doses of vaccines from Pfizer-BioNTech and Moderna distributed by the end of the year — just enough to immunize 20 million people with the two-dose vaccine, the Post said.

Who will get the vaccine first, and in what order?
The CDC has decided that health care workers and people working or living in long-term care facilities will be the first folks to get the COVID-19 vaccine. There are about 21 million health care workers and about 3 million people at long-term care facilities, so their inoculations will account for the first 48 million doses of the two-dose vaccine. It’s not clear who will be next in line. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet in the coming weeks to make recommendations for the groups to be included in subsequent waves. The next phase of priority vaccinations could focus on essential workers such as educators, food and agriculture workers, utility workers, police, firefighters, corrections officers and transportation employees, according to a slideshow presented at the Dec. 1 meeting of the ACIP.

This represents about 87 million people, and also would promote vaccination among minority communities that have been hit hard by the pandemic, the Post reported. After that, people aged 65 and older (about 53 million) and adults with high-risk medical conditions (about 100 million) could be next in line for vaccination, the presentation noted. The CDC likely will decide as part of its rollout strategy which high-risk conditions should be placed at higher priority than others, Schaffner said. For example, health officials will have to weigh placing people with compromised immune systems like cancer patients and transplant recipients in line ahead of people with heart or lung ailments, diabetics or folks who are obese.

How will I know when it’s my turn and where I should go to get my shot?
Average folks probably will learn it’s their turn for the COVID-19 vaccine from their local media, Schaffner said. “State and local health departments will communicate that through TV, newspapers, radio and the like,” Schaffner explained. Health care workers are being advised by their employers that they will constitute the first wave of immunization, said Susan Mashni, chief pharmacy officer for the Mount Sinai Health System in New York City. “We’ve already started internally town halls and huddles and manager meetings with staff to let them know they’re going to be in the first wave of folks who are eligible,” Mashni said of Mount Sinai. Doctors who care for high-risk patients also are likely to promote outreach to those people when their turn comes, Mashni added. “We will be doing outreach to our patient population, to let them know they’re in that category and that we’ve received vaccine and are ready to accept the patients,” Mashni said. “Physician groups within Mount Sinai have been advocating for their patients, to make certain that when we’re getting the allocations that we’re aware who the highest risk patients are.”

Will I get some proof that I got the vaccine, like a vaccine certificate?
It’s expected that people who receive the COVID-19 vaccine will receive some sort of paperwork. The form of that documentation will be described in the emergency use authorization that each vaccine receives from the FDA, Mashni said. “I believe we’ll be giving people a card that shows the lot number of the vaccine they received,” Mashni said. “Then we’ll make certain at the time they get their first vaccine that they are also scheduled for their second vaccine.”  One important reason for this paperwork is that a person must get the same vaccine from the same manufacturer for their first and second doses, Mashni and Schaffner explained. The paperwork also will help health officials track vaccine distribution and make sure all doses are being efficiently disbursed, Schaffner added. “Every dose of vaccine will have to be accounted for,” Schaffner said. “The state health departments are going to be very tough about that. They will want to know that vaccine is not remaining unused in a refrigerator and they will want to know who received the vaccine, and which vaccine they received so that you can plan rigorously the second dose.”

How long will I have to wait between doses?
The good news is that Pfizer’s vaccine offers strong protection after the first dose, The New York Times reported. The efficacy of the vaccine after the first dose is about 52%, and after the second dose, that rises to about 95%. But you will have to wait three to four weeks between your first and second dose, depending on whether you get the Pfizer or Moderna vaccine. “If you miss and you come in later, no problem, you don’t have to repeat the first dose,” Schaffner said. “We just don’t want you to get the dose too soon. That’s not optimal for your immune system.”

If I’ve already had COVID-19, do I need to get the vaccine?
People who’ve had COVID-19 will need to receive the vaccine same as everyone else, Schaffner said. “They will be asked to stand in line and get a vaccine also,” Schaffner said. “There will be no distinction made, in part because we think there’s no adverse event that will occur, and also the protection from the vaccine actually may be more long-lived, of longer duration than that you get from the natural infection.” Coronaviruses are notorious for promoting short-lived immunity in humans, explained Dr. Greg Poland, director of the Vaccine Research Group at the Mayo Clinic, in Rochester, Minn. “With the four seasonal beta coronaviruses that circulate and cause all the upper respiratory infections you see in your practice, those people lose immunity in months to a year or two,” Poland said. That’s why people fall prey to the common cold again and again.

This happens because the body uses a relatively simple strategy to fight off common cold coronaviruses, and this strategy does not appear to make a lasting impression on immune system memory, Poland said. There’s a chance people who had asymptomatic or mild cases of COVID-19 did not build up any lasting immunity; at this point it is unclear what sort of immunity is conferred even by severe cases. More threatening coronavirus diseases like SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) appear to produce immunity that potentially lasts longer, but the data is limited because both viruses have infected far fewer people than COVID-19, experts said. “This virus is so new that we don’t know very much about levels of protection and their duration. We’re all together on this, learning as we go along,” Schaffner said.

How should I expect to feel after I get the vaccine?
The two-dose Pfizer-BioNTech and Moderna vaccines use what’s called a “prime/boost” strategy, Schaffner said. “The first inoculation kind of alerts the immune system, and it’s the second inoculation that really gets the immune system worked up,” Schaffner said. People should not be surprised if they feel under the weather after receiving either dose, but especially the booster, Schaffner and Offit said. “When your immune response is activated you have certain symptoms, which can be things like low-grade fever, headache, muscle ache and fatigue, enough so that you could actually miss a day of work,” Offit said. “I wish the immune system had a better public relations team working for it. This is just a natural consequence of having an activated immune system.” When it’s your turn to get either dose, make sure you don’t make any plans for the next day, Schaffner advises. “This is not COVID. This is merely the immune system revving up and responding to the vaccine. But it is sufficient that some people might not want to go to work that next day,” Schaffner said. Hospitals are taking this into account when scheduling vaccinations for their employees, Offit said. “You’re not going to vaccinate your whole emergency department and have them potentially be out the next day,” Offit said.

Do I get to resume normal life after receiving the vaccine?
Vaccination might produce delightful thoughts of throwing your mask away and hugging dear friends, but you will have to resist the urge. People will still need to maintain infection control habits even after they’ve received their shots. “The trials have shown us that the vaccine prevents the occurrence of disease and severe disease. They were not designed to tell us whether it prevents infection,” Schaffner said. Given that, a person who received the vaccine might well be able to spread the novel coronavirus even though their risk of falling seriously ill with COVID-19 is low. “You could be infected and you could be contagious even though you had the vaccine,” Schaffner said. “We don’t know that, but we don’t know it’s not true. We are going to ask everyone to keep masking and observing social distancing until we are complete.”

How many Americans will need to be immunized before we achieve herd immunity?
The COVID-19 coronavirus has a transmission rate greater than three, meaning that every infected person can be expected to spread the virus to three other folks unless infection control measures are maintained. “The goalpost for herd immunity has to be fairly high because this is a highly contagious virus,” Schaffner said. “I would anticipate around 70%. That is a very high goal post, trying to get 70% of the United States population vaccinated to really flatten the curve of transmission.”

More information
The U.S. Food and Drug Administration has more about COVID-19 vaccines https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

SOURCES: William Schaffner, MD, professor, infectious disease, Vanderbilt University Medical Center, Nashville, Tenn.; Paul Offit, MD, director, Vaccine Education Center, Children’s Hospital of Philadelphia; Susan Mashni, PharmD, chief pharmacy officer, Mount Sinai Health System, New York City; Greg Poland, MD, director, Vaccine Research Group, Mayo Clinic, Rochester, Minn.