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CDC’s Independent Vaccine Advisers Recommend Maternal Vaccine To Protect Infants From RSV

RSV

(CTN NEWS) – As we gear up for the fall season, the Centers for Disease Control and Prevention (CDC) has made a significant recommendation that could safeguard the health of infants across the United States.

The CDC’s recent endorsement of Pfizer’s maternal vaccine for respiratory syncytial virus (RSV) is poised to make a profound impact on maternal and child healthcare.

In this blog post, we’ll explore the importance of this recommendation, the need for RSV prevention, and the promise of Pfizer’s Abrysvo vaccine.

Understanding the RSV Threat

RSV, short for respiratory syncytial virus, might not be a household name, but it poses a significant threat to infants in the United States. It is the leading cause of hospitalization among babies in the country.

While RSV typically manifests as mild, cold-like symptoms in adults, it can have severe consequences for infants and older adults.

Each year, RSV claims the lives of hundreds of children under the age of 5 and leads to 6,000 to 10,000 senior fatalities, according to the CDC. Additionally, it causes between 58,000 to 80,000 hospitalizations among children under 5 years old annually.

Last year, the nation experienced an unusually severe season of RSV, highlighting the need for effective preventive measures.

FILE PHOTO: View of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo during its manufacture in this undated handout picture. Pfizer/Handout via REUTERS/File Photo

The CDC’s Vital Recommendation

In response to the RSV threat, the CDC has issued a crucial recommendation for expectant mothers. Specifically, the agency recommends that pregnant individuals who are 32 to 36 weeks into their pregnancy should receive Pfizer’s Abrysvo vaccine.

This recommendation is in effect from September through January, aligning with the heightened RSV season.

The CDC’s Director, Mandy Cohen, emphasized the importance of this recommendation as a new tool to protect lives during the fall and winter months.

The key to Pfizer’s Abrysvo vaccine lies in its unique approach. It is the first RSV treatment to use maternal immunization. Expectant mothers receive the vaccine, which triggers the production of antibodies that are passed on to the fetus.

This provides infants with protection against RSV from birth through their first six months of life. The Food and Drug Administration (FDA) established the 32- to 36-week dosing timeframe when approving the shot.

The Path Forward

Pfizer’s maternal vaccine, Abrysvo, represents a significant step forward in RSV prevention.

The company estimates that this vaccine could prevent up to 16,000 hospitalizations and over 300,000 doctor visits due to RSV if it becomes widely available in the United States this fall and winter.

It’s worth noting that the FDA and CDC previously cleared an RSV antibody injection for infants from Sanofi and AstraZeneca. However, this treatment is administered directly to babies, whereas Pfizer’s vaccine offers maternal immunization, providing protection even before birth.

Dr. Luis Jodar, Pfizer’s Chief Medical Officer for Vaccine Medical Development, stated,

“This fall marks the start of the annual respiratory infection season in the Northern Hemisphere, and we are prepared with vaccines against multiple infectious diseases and – for the first time in history – an available RSV vaccine to help prevent disease in two at-risk populations.”

Making Informed Choices

The CDC’s advisory panel acknowledges that most infants may not require both Pfizer’s Abrysvo and the RSV antibody injection (Beyfortus) from Sanofi and AstraZeneca.

The decision regarding which RSV prevention product to use during pregnancy will be made by the pregnant individual in consultation with their prenatal care provider.

As we approach the fall and winter months, the CDC’s recommendation for Pfizer’s maternal vaccine is a beacon of hope for expectant mothers and their infants.

It underscores the importance of proactive healthcare measures in protecting our youngest and most vulnerable citizens from the impact of RSV.

It’s a significant step forward in our ongoing battle against respiratory illnesses, and it offers new opportunities for parents to ensure the well-being of their little ones.

(AP Photo/George Walker IV)

Safety and Efficacy of Pfizer’s Maternal Vaccine for RSV

The recent recommendation by the CDC panel for Pfizer’s maternal vaccine to protect infants from respiratory syncytial virus (RSV) is undoubtedly a significant step forward in healthcare.

However, alongside the efficacy of this vaccine, concerns have been raised regarding its safety, particularly related to the timing of administration and potential risks associated with preterm births.

Efficacy in Preventing RSV

The CDC panel’s recommendation is based on comprehensive data from a phase three trial involving nearly 7,400 participants.

During this trial, expectant mothers received the Pfizer shot between 24 to 36 weeks into their pregnancy, which is a broader period than the approved dosing timeframe recommended by the FDA (32 to 36 weeks).

The results of this trial revealed promising efficacy levels in preventing severe RSV disease in newborns.

Within the first 90 days after birth, the vaccine demonstrated an impressive 82% effectiveness in preventing severe RSV disease and a 57% effectiveness in averting doctor’s visits due to RSV-related breathing problems in infants.

However, it’s important to note that the vaccine’s efficacy appeared to decrease slightly over time. By six months after birth, Pfizer’s shot was approximately 70% effective in preventing severe disease and 51% effective in reducing doctor visits related to RSV.

Safety Concerns and Preterm Births

While the efficacy of Pfizer’s maternal vaccine received praise, concerns were expressed regarding potential safety risks

. Notably, the trial reported a slightly higher rate of premature births among mothers who received the vaccine compared to those who received a placebo – 5.7% versus 4.7%, respectively.

It’s worth noting that this difference was not considered statistically significant by Pfizer, the FDA, and CDC staff.

In response to these concerns, Pfizer provided additional, unpublished data to the CDC advisory panel.

This data suggested that the rate of preterm births actually decreased for women who received the vaccine during the approved dosing time frame of 32 to 36 weeks into pregnancy. In this group, 4.2% of births were premature compared to 3.7% among those who received a placebo.

FDA’s Caution and Post-Marketing Studies

Despite the promising data, the FDA has included a cautionary note in the prescribing label for Pfizer’s vaccine. It warns against administering the shot before 32 weeks of pregnancy due to the “numerical imbalance” in premature births observed during the trial.

To address these safety concerns, the FDA is requiring Pfizer to conduct a post-marketing study on the vaccine. Post-marketing studies are conducted after a product receives FDA approval and are aimed at further assessing safety and efficacy.

Pfizer’s examination will include an evaluation of any pregnancy-related complications following vaccination, such as eclampsia.

Additionally, Pfizer will launch a pregnancy registry to allow women and obstetricians to report any adverse events after receiving the vaccine. This registry will play a vital role in continuously monitoring the vaccine’s safety in real-world scenarios.

In conclusion, Pfizer’s maternal vaccine for RSV offers significant promise in protecting infants from a potentially severe illness.

While safety concerns have been raised, the FDA and CDC are taking proactive steps to closely monitor and assess the vaccine’s safety profile through post-marketing studies.

As expectant mothers and healthcare providers make informed decisions about vaccination, ongoing research and data analysis will be crucial in ensuring the safety and efficacy of this important preventive measure.

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Google’s Search Dominance Is Unwinding, But Still Accounting 48% Search Revenue

Google

Google is so closely associated with its key product that its name is a verb that signifies “search.” However, Google’s dominance in that sector is dwindling.

According to eMarketer, Google will lose control of the US search industry for the first time in decades next year.

Google will remain the dominant search player, accounting for 48% of American search advertising revenue. And, remarkably, Google is still increasing its sales in the field, despite being the dominating player in search since the early days of the George W. Bush administration. However, Amazon is growing at a quicker rate.

google

Google’s Search Dominance Is Unwinding

Amazon will hold over a quarter of US search ad dollars next year, rising to 27% by 2026, while Google will fall even more, according to eMarketer.

The Wall Street Journal was first to report on the forecast.

Lest you think you’ll have to switch to Bing or Yahoo, this isn’t the end of Google or anything really near.

Google is the fourth-most valued public firm in the world. Its market worth is $2.1 trillion, trailing just Apple, Microsoft, and the AI chip darling Nvidia. It also maintains its dominance in other industries, such as display advertisements, where it dominates alongside Facebook’s parent firm Meta, and video ads on YouTube.

To put those “other” firms in context, each is worth more than Delta Air Lines’ total market value. So, yeah, Google is not going anywhere.

Nonetheless, Google faces numerous dangers to its operations, particularly from antitrust regulators.

On Monday, a federal judge in San Francisco ruled that Google must open up its Google Play Store to competitors, dealing a significant blow to the firm in its long-running battle with Fortnite creator Epic Games. Google announced that it would appeal the verdict.

In August, a federal judge ruled that Google has an illegal monopoly on search. That verdict could lead to the dissolution of the company’s search operation. Another antitrust lawsuit filed last month accuses Google of abusing its dominance in the online advertising business.

Meanwhile, European regulators have compelled Google to follow tough new standards, which have resulted in multiple $1 billion-plus fines.

google

Pixa Bay

Google’s Search Dominance Is Unwinding

On top of that, the marketplace is becoming more difficult on its own.

TikTok, the fastest-growing social network, is expanding into the search market. And Amazon has accomplished something few other digital titans have done to date: it has established a habit.

When you want to buy anything, you usually go to Amazon, not Google. Amazon then buys adverts to push companies’ products to the top of your search results, increasing sales and earning Amazon a greater portion of the revenue. According to eMarketer, it is expected to generate $27.8 billion in search revenue in the United States next year, trailing only Google’s $62.9 billion total.

And then there’s AI, the technology that (supposedly) will change everything.

Why search in stilted language for “kendall jenner why bad bunny breakup” or “police moving violation driver rights no stop sign” when you can just ask OpenAI’s ChatGPT, “What’s going on with Kendall Jenner and Bad Bunny?” in “I need help fighting a moving violation involving a stop sign that wasn’t visible.” Google is working on exactly this technology with its Gemini product, but its success is far from guaranteed, especially with Apple collaborating with OpenAI and other businesses rapidly joining the market.

A Google spokeswoman referred to a blog post from last week in which the company unveiled ads in its AI overviews (the AI-generated text that appears at the top of search results). It’s Google’s way of expressing its ability to profit on a changing marketplace while retaining its business, even as its consumers steadily transition to ask-and-answer AI and away from search.

google

Google has long used a single catchphrase to defend itself against opponents who claim it is a monopoly abusing its power: competition is only a click away. Until recently, that seemed comically obtuse. Really? We are going to switch to Bing? Or Duck Duck Go? Give me a break.

But today, it feels more like reality.

Google is in no danger of disappearing. However, every highly dominating company faces some type of reckoning over time. GE, a Dow mainstay for more than a century, was broken up last year and is now a shell of its previous dominance. Sears declared bankruptcy in 2022 and is virtually out of business. US Steel, long the foundation of American manufacturing, is attempting to sell itself to a Japanese corporation.

Could we remember Google in the same way that we remember Yahoo or Ask Jeeves in decades? These next few years could be significant.

SOURCE | CNN

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2024 | Supreme Court Won’t Hear Appeal From Elon Musk’s X Platform Over Warrant In Trump Case

trump

Washington — Trump Media,  The Supreme Court announced Monday that it will not hear an appeal from social media platform X about a search warrant acquired by prosecutors in the election meddling case against former President Donald Trump.

The justices did not explain their rationale, and there were no recorded dissents.

The firm, which was known as Twitter before being purchased by billionaire Elon Musk, claims a nondisclosure order that prevented it from informing Trump about the warrant obtained by special counsel Jack Smith’s team violated its First Amendment rights.

The business also claims Trump should have had an opportunity to exercise executive privilege. If not reined in, the government may employ similar tactics to intercept additional privileged communications, their lawyers contended.

trump

Supreme Court Won’t Hear Appeal From Elon Musk’s X Platform Over Warrant In Trump Case

Two neutral electronic privacy groups also joined in, urging the high court to hear the case on First Amendment grounds.

Prosecutors, however, claim that the corporation never shown that Trump utilized the account for official purposes, therefore executive privilege is not a problem. A lower court also determined that informing Trump could have compromised the current probe.

trump

Trump utilized his Twitter account in the weeks preceding up to his supporters’ attack on the Capitol on January 6, 2021, to spread false assertions about the election, which prosecutors claim were intended to create doubt in the democratic process.

The indictment describes how Trump used his Twitter account to encourage his followers to travel to Washington on Jan. 6, pressuring Vice President Mike Pence to reject the certification, and falsely claiming that the Capitol crowd, which battered police officers and destroyed glass, was peaceful.

musk trump

Supreme Court Won’t Hear Appeal From Elon Musk’s X Platform Over Warrant In Trump Case

That case is now moving forward following the Supreme Court’s verdict in July, which granted Trump full immunity from criminal prosecution as a former president.

The warrant arrived at Twitter amid quick changes implemented by Musk, who bought the company in 2022 and has since cut off most of its workforce, including those dedicated to combating disinformation and hate speech.

He also welcomed back a vast list of previously banned users, including Trump, and endorsed him for the 2024 presidential election.

SOURCE | AP

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The Supreme Court Turns Down Biden’s Government Appeal in a Texas Emergency Abortion Matter.

Supreme Court

(VOR News) – A ruling that prohibits emergency abortions that contravene the Supreme Court law in the state of Texas, which has one of the most stringent abortion restrictions in the country, has been upheld by the Supreme Court of the United States. The United States Supreme Court upheld this decision.

The justices did not provide any specifics regarding the underlying reasons for their decision to uphold an order from a lower court that declared hospitals cannot be legally obligated to administer abortions if doing so would violate the law in the state of Texas.

Institutions are not required to perform abortions, as stipulated in the decree. The common populace did not investigate any opposing viewpoints. The decision was made just weeks before a presidential election that brought abortion to the forefront of the political agenda.

This decision follows the 2022 Supreme Court ruling that ended abortion nationwide.

In response to a request from the administration of Vice President Joe Biden to overturn the lower court’s decision, the justices expressed their disapproval.

The government contends that hospitals are obligated to perform abortions in compliance with federal legislation when the health or life of an expectant patient is in an exceedingly precarious condition.

This is the case in regions where the procedure is prohibited. The difficulty hospitals in Texas and other states are experiencing in determining whether or not routine care could be in violation of stringent state laws that prohibit abortion has resulted in an increase in the number of complaints concerning pregnant women who are experiencing medical distress being turned away from emergency rooms.

The administration cited the Supreme Court’s ruling in a case that bore a striking resemblance to the one that was presented to it in Idaho at the beginning of the year. The justices took a limited decision in that case to allow the continuation of emergency abortions without interruption while a lawsuit was still being heard.

In contrast, Texas has been a vocal proponent of the injunction’s continued enforcement. Texas has argued that its circumstances are distinct from those of Idaho, as the state does have an exemption for situations that pose a significant hazard to the health of an expectant patient.

According to the state, the discrepancy is the result of this exemption. The state of Idaho had a provision that safeguarded a woman’s life when the issue was first broached; however, it did not include protection for her health.

Certified medical practitioners are not obligated to wait until a woman’s life is in imminent peril before they are legally permitted to perform an abortion, as determined by the state supreme court.

The state of Texas highlighted this to the Supreme Court.

Nevertheless, medical professionals have criticized the Texas statute as being perilously ambiguous, and a medical board has declined to provide a list of all the disorders that are eligible for an exception. Furthermore, the statute has been criticized for its hazardous ambiguity.

For an extended period, termination of pregnancies has been a standard procedure in medical treatment for individuals who have been experiencing significant issues. It is implemented in this manner to prevent catastrophic outcomes, such as sepsis, organ failure, and other severe scenarios.

Nevertheless, medical professionals and hospitals in Texas and other states with strict abortion laws have noted that it is uncertain whether or not these terminations could be in violation of abortion prohibitions that include the possibility of a prison sentence. This is the case in regions where abortion prohibitions are exceedingly restrictive.

Following the Supreme Court’s decision to overturn Roe v. Wade, which resulted in restrictions on the rights of women to have abortions in several Republican-ruled states, the Texas case was revisited in 2022.

As per the orders that were disclosed by the administration of Vice President Joe Biden, hospitals are still required to provide abortions in cases that are classified as dire emergency.

As stipulated in a piece of health care legislation, the majority of hospitals are obligated to provide medical assistance to patients who are experiencing medical distress. This is in accordance with the law.

The state of Texas maintained that hospitals should not be obligated to provide abortions throughout the litigation, as doing so would violate the state’s constitutional prohibition on abortions. In its January judgment, the 5th United States Circuit Court of Appeals concurred with the state and acknowledged that the administration had exceeded its authority.

SOURCE: AP

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Scientists Awarded MicroRNA The Nobel Prize in Medicine.

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