(NEW YORK) — American pharmaceutical company Pfizer and its German partner BioNTech announced Friday that a booster dose of their bivalent COVID-19 vaccine performs better against two circulating versions of the omicron variant, compared with a booster shot of their original vaccine.

According to a joint press release, updated data from a Phase 2-3 clinical trial shows the Pfizer-BioNTech bivalent vaccine produced antibody responses against the BA.4 and BA.5 omicron subvariants that were three- to four-fold higher, compared with the original formula, when measured in adults approximately one month after receiving a booster dose. The safety and tolerability profile of the bivalent booster remains favorable and similar to the original vaccine, Pfizer and BioNTech said.

“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Pfizer chairman and CEO Albert Bourla said in a statement Friday. “These updated data also provide confidence in the adaptability of our mRNA platform and our ability to rapidly update the vaccine to match the most prevalent strains each season.”

Other smaller studies by independent scientists have suggested there is very little difference between antibody responses produced by the original and updated shots, though both boosted antibody protection.

All of these studies are conducted by taking blood samples from recently vaccinated people and measuring antibodies in a lab. They give us a hint of how well the vaccines might work, but do not tell the full story of their effectiveness. Vaccines are still expected to offer a high level of protection against severe illness.

In late August, the U.S. Food and Drug Administration authorized two updated booster vaccines — the one developed by Pfizer and BioNTech, and another by American biotechnology company Moderna — that were designed to be a better match against the BA.4 and BA.5 subvariants. Since then, just over 26 million eligible Americans have received the updated booster shots, according to the Centers for Disease Control and Prevention.

The BA.5 subvariant currently is estimated to account for half of all new COVID-19 cases in the United States, according to the CDC, but it’s unlikely to remain the dominant viral strain for much longer. Newer versions of the omicron variant, such as BQ.1 and BQ.1.1, are slowly overtaking as a proportion of estimated cases. These subvariants are descendants of BA.5, but it remains unclear how well the bivalent boosters will work against them.

As the world nears its third year of the COVID-19 pandemic and the virus continues to evolve, booster shots are expected to bolster protection against severe illness but not necessarily mild or asymptomatic breakthrough infections.

“These data demonstrate that our BA.4/BA.5-adapted bivalent vaccine works as conceptually planned in providing stronger protection against the Omicron BA.4 and BA.5 sublineages,” BioNTech CEO and co-founder Ugur Sahin said in a statement Friday. “In the next step and as part of our science based approach we will continue to evaluate the cross-neutralization of the adapted vaccine against new variants and sublineages. Our aim is to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron and other circulating strains.”

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(NEW YORK) — In what could signal the promise of progress to come for newborn infants at risk for RSV, a new monoclonal antibody is being granted approval in Europe as a preventative measure to protect against RSV infection in very young babies — those most at risk of contracting the virus — during their first RSV season.

Developed jointly by Sanofi and AstraZeneca, commercially called “Beyfortus®,” this monoclonal antibody is given via a single dose intramuscular injection to infants aged 0 to 12 months, to protect against RSV before they get infected, from birth up through their first RSV (respiratory syncytial virus) season. The European Commission announced Friday morning it had approved the drug.

This does not mean it is an option for American babies, at least not yet. Sanofi and AstraZeneca will still have to go through the U.S. regulatory process for that — Food and Drug Administration approval, and recommendation by advisory panels like the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

While the European approval does not impact the US regulatory process — FDA makes its own decisions — this new European approval shows it’s good enough to get the green light there, and could get the green light here as well.

If and when the FDA does approve this antibody, it won’t be in time for this season’s surge. But it could get approved in time for next year.

Sanofi tells ABC News they and AstraZeneca have already submitted their clinical trial data to the FDA. They expect to finalize their submission to the FDA by the end of this year, with the hopes of it being approved and available by the fall/winter of 2023/2024.

“It’s really exciting news. We’ve been looking for solutions to be able to prevent RSV for close to 50 years,” Dr. Michael Greenberg, a pediatrician and vice president, Sanofi’s Medical Head of Vaccines for North America, told ABC News in an interview.

He noted that once available, it could offer an important “first tool that we have to be able to protect all babies going into their first RSV season.”

This monoclonal antibody, called Beyfortus, is a lab-made, synthetic version of RSV immunity that newborn babies don’t have time to develop on their own, with their short time on earth.

That could change once a maternal RSV vaccine is approved and available — but for now — it could offer an important stopgap of protection for a vulnerable population, especially looking ahead from amid the current influx of pediatric RSV infections currently surging in the U.S.

A sampling of national CDC data shows RSV cases recorded for all ages are occurring more than twice as high at this point this year compared to last year, with more than twice as many cases per week, and likely leading towards more severe cases, especially in pediatric emergency departments and pediatric hospitalizations, which have limited resources to begin with, according to Chief Innovation Officer at Boston Children’s Hospital and ABC News Contributor, Dr. John Brownstein.

Newborn infants are at the highest risk of RSV infection, especially those who are born prematurely or immune compromised. Their heads are big, their airways small, and they have no built-up immunity. It is a leading cause of hospitalization in infants in the U.S.

This monoclonal could be a notable measure of protection for babies, wherever it’s approved, available and accessible to those who need it.

“Speaking as a pediatrician as someone who’s worked in public health, we always try to prevent, rather than having to treat — which is why we use vaccines for example — it’s better to prevent illnesses than to treat it,” Greenberg said.

“The idea is that a baby would get it for example, if they’re born during the time when RSV is circulating, like now, they would get it before they leave the hospital after being born, or if they’re born before the RSV season, they would get it in their pediatricians office during a normal well child visit,” Greenberg continued. “It’s designed to be able to protect from a very rapid standpoint, for that first RSV season.”

It is designed to keep RSV from being as serious as it can be in the population most vulnerable to severe infection — newborns.

So, while Beyfortus may not prevent all infections, like milder ones, it does buy important time for the most vulnerable tiny babies to grow larger and stronger and less likely to get hit as hard by RSV.

During the pandemic, many kids weren’t as exposed to many of the viruses they would have been otherwise, during the course of a normal childhood — because of masking, social distancing, remote learning, etc. during their very early years.

One theory to explain the unusually high number of RSV infections says that babies who would have been affected earlier on in life in a normal setting were instead born into the COVID bubble — which may have caused a delay in their built-up immunity, experts say.

Now, as the masks have come down, the infection rates are going up at even higher rates, and experts emphasize how COVID-19 has thrown the typical seasonality of our respiratory viral waves.

There is also no vaccine for RSV yet, while there is, of course, for COVID and the flu.

“The holy grail for durable RSV protection remains the illusive vaccine which now seems to be on the horizon,” Brownstein said. “Nonetheless the availability of these therapies will play an important role as a stop gap, likely an important tool to protect high risk babies from complications of RSV infection.”

There have been recent and promising developments with the data on Pfizer’s maternal RSV vaccine candidate — and while they can now move forward with the approval process, that vaccine won’t be immediately available to families worried about the current surge. FDA approval and CDC recommendation are possible next year.

And in the newborns most at risk for severe RSV, they have not lived long enough for a vaccine given directly to them to have enough time to build sufficient immunity.

Enter, alternatives like this monoclonal antibody: a synthetic version of that immunity which can help ward off infection.

In a randomized placebo-controlled phase 2/3 trial, Beyfortus showed an efficacy of more than 77% (77.3%) against infants’ RSV lower respiratory tract infection hospitalizations.

“I think we just have to be able to be prepared, and have tools like this to be able to respond,” Greenberg said. “So that whatever the epidemiology is, we’ve got the means to be able to protect all infants going into the RSV season, whenever the RSV season happens.”

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(NEW YORK) — The Food and Drug Administration has released a safety bulletin urging parents and caregivers not to use head-shaping pillows intended to change an infant’s head shape or symmetry.

There has been no proven benefit of using these pillows for any medical purpose, and in fact, using these pillows can create an unsafe sleeping environment for infants and may increase the risk of suffocation and death, the agency warned.

“Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established for the prevention or treatment of flat head syndrome (also known as positional plagiocephaly or deformational plagiocephaly), or the more serious condition where the developing infant’s skull bones join together too early (known as craniosynostosis),” the FDA said. “Do not use infant head shaping pillows due to the risk of sudden unexpected infant death (SUID), inclusive of sudden infant death syndrome (SIDS), and suffocation and death.”

The agency advised anyone who owns one of these pillows to throw it away, and not donate it or give it to anyone else.

“Be aware that, in most cases, flat head syndrome will go away on its own as an infant grows, it is not painful and it does not cause any developmental concerns,” the FDA said.

“If your infant has an unusual head shape, talk to your infant’s health care provider about management options,” the agency added. “Know that the use of infant head shaping pillows may delay the necessary evaluation and management of harmless conditions, such as flat head syndrome, or more serious conditions, such as craniosynostosis.”

To promote a safe sleep environment, the National Institutes of Health and the American Academy of Pediatrics recommend infants sleep on their backs in a bare crib on a firm and flat (not inclined) surface without pillows, toys, soft objects or loose bedding.

The AAP also recommends that caregivers not share a bed with infants to reduce the risk of SIDS. Instead, parents and caregivers can share the same room with a baby 6 months and under and should check on them to make sure they don’t overheat while sleeping.

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(NEW YORK) — The Centers for Disease Control and Prevention released updated guidelines for prescribing opioids for pain to include people who are suffering from short-term pain.

During a briefing Thursday, the federal health agency said its new clinical practice recommendations are replacing guidelines from 2016 to make them more flexible.

“Pain affects the lives of millions of Americans and improving care for those living with pain is a public health imperative,” Dr. Christopher Jones, acting director of the CDC’s National Center for Injury Prevention and Control, told reporters during the briefing.

The 2016 guidelines focused almost exclusively on prescribing for patients who have chronic pain, described as pain that lasts longer than three months.

But the new guidelines include those suffering from acute pain, which last less than a month and can include pain following a minor surgery or a broken bone, and subacute pain, which lasts longer than a month but is not yet considered chronic.

“It’s particularly important that the guidelines address this type of pain, as research shows that long-term opioid therapy often is initiated during this acute timeframe,” Jones said.

Jones added that by updating the recommendations, Americans who suffer from pain may have improved quality of life and, hopefully, misuse of prescription opioids will decline.

The U.S. has been battling an opioid crisis for years as more Americans fatally overdose from the drugs.

During the COVID-19 pandemic, drug overdose deaths hit record-highs. More than 100,000 people died from drugs from April 2020 to April 2021, according to the CDC.

That’s a 29% increase from 2019 and equivalent to an American dying every five minutes, said the Drug Enforcement Administration.

The CDC says the first wave of the opioid overdose death crisis began in the 1990s, when people were dying after overuse of prescription opioids, such as oxycodone and methadone.

The second wave started in 2010 due to a sharp spike in overdose deaths due to heroin. The third wave began in 2013 with rates rising due to synthetic opioids, particularly illicitly manufactured fentanyl — which is 50 to 100 times stronger than morphine.

“Actions related to the current state of the overdose crisis, which are very much driven by illicit synthetic opioids, like illicitly made fentanyl [and] resurgent methamphetamine, are not the aim of this guideline today,” Jones said. “That work is happening across the government as a whole-of-government approach, including work from CDC to support our state and local partners.”

He continued, “I don’t think it’s an either/or. I think we can pursue both of those at the same time.”

In addition, the guidelines have been updated to explicitly advise against the abrupt discontinuation or reduction of opioid use.

“There are very real harms, and we try to highlight that in the guidelines,” Jones said. “So things like mental health crises, suicidal ideation or behavior, psychological distress, and potentially even for some people seeking out opioids through other markets like illicit markets in order to stave off withdrawal or to supplement if they’re at too low of a dose.”

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