Pfizer completes application to FDA for vaccine for children under 5

 Pfizer said on Wednesday that is has completed its emergency use application to the Food and Drug Administration (FDA) to administer its COVID-19 vaccine to children under the age of 5.

Pfizer said in a statement that its application for the vaccine, developed with BioNTech, “includes safety, immunogenicity and efficacy data” from previous clinical research on young children who received a third dose at least two months after their second shot.

The FDA’s vaccine advisory committee is slated to meet on June 15 to look at expanding the Pfizer-BioNTech emergency use authorization to include children under the age of 5, and Pfizer said its clinical data would be reviewed during that meeting.

A decision regarding authorizing the vaccine for children under 5 could be made soon after the meeting.

Last week, Pfizer offered promising signs on the efficacy of its children’s vaccine, saying research showed it was roughly 80 percent effective for those under 5.

Pfizer and BioNTech announced in February that they did not have enough data regarding the third dose’s efficacy for children, delaying their FDA authorization request.

The U.S. has seen rising cases in recent weeks, though they remain well below levels seen in previous COVID-19 waves, such as last winter’s omicron spike.

https://thehill.com/policy/healthcare/3509038-pfizer-completes-application-to-fda-for-vaccine-for-children-under-5/

Transcript: AmerisourceBergen Analyst/Investor Day

 https://www.marketscreener.com/quote/stock/AMERISOURCEBERGEN-CORPORA-9428091/news/Transcript-AmerisourceBergen-Corporation-Analyst-Investor-Day-40613184/

Transcript: Pfizer at Bernstein Strategic Directions Conference

 https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Transcript-Pfizer-Inc-Presents-at-Bernstein-38th-Annual-Strategic-Decisions-Conference-Jun-01-20-40611207/

Novartis resumes Ukraine business

 

Novartis is resuming business in Ukraine after reviewing how safe it was to operate in the country that Russia invaded in February, the Swiss drugmaker said.

"After studying current safety protocols in the country, and on advice which we will regularly review, we have begun to resume business operations remotely to help the war-torn country restore some basic critical business processes," Novartis said on its website https://www.novartis.com/news/novartis-resumes-business-ukraine in a post dated June 1.

"The safety and security of our people remains our number one objective, and we will constantly review the situation and our business operations in Ukraine."

Novartis said it condemned the war in Ukraine and has been providing humanitarian support, financial donations and medicine to people there. Russia describes its invasion as a "special military operation" to disarm and "de-Nazify" its neighbour.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/Swiss-drugmaker-Novartis-resumes-Ukraine-business-40616614/

Researchers Closer To Creating Blood Test For Suicide Risk

 by Carol Cassis via The Epoch Times,

Researchers have discovered an approach to identify blood biomarkers that could predict the risk of suicide in patients with depression, bringing them one step closer to developing a potential blood test for use on future patients thanks to a study by researchers at the University of California–Irvine (UCI) and Pritzker Research Consortium.

Suicides have increased to nearly 50,000 deaths yearly in the United States and around 800,000 total globally, according to the team’s research now published in Translational Psychiatry, a peer-reviewed medical journal launched in 2011. The 2022 study further shows clinical depression as the most common diagnosis among suicides.

Even more troubling is that in the United States alone, suicide rates have increased by more than 35 percent over the last 20 years, the study says, making it the tenth leading cause of death.

“Identifying those at the highest risk is a pressing challenge,” researchers note in the literature, adding that “suicide prevention strategies and current medications, although helpful, have not stemmed the increase in self-inflicted deaths.”

As such, researchers launched an investigation to see if a blood biomarker signature for depression could be identified in post-mortem patients who took their own lives, studying both brain and blood cells. Their efforts were successful.

In their research, scientists found that non-preserved blood can be used to discover a gene that, when expressed or activated, makes people at a higher risk of suicide.

Not only can this discovery help providers pinpoint suicidal individuals, the results can also help researchers understand molecular changes in suicide victims, which may be of great use in treating the illness moving forward.

“That is so cool, I didn’t even know you could test for something like that … in someone’s blood,” a source diagnosed with depression, who wished to remain anonymous, told The Epoch Times.

“I wish that test was already available when I was in high school.”

The study uses a novel gene expression approach—a way to look for clusters of genes encoded in our DNA that make people at higher risk for certain conditions—in this case the genetic code specific to putting people at risk of suicidal tendencies.

Research further shows that many individuals do not disclose suicidal intentions despite frequent contact with health care professionals and that an estimated 30 percent of suicides visit a healthcare provider within a month of taking their lives.

As such, once developed this blood test can be administered during such medical visits, potentially helping to identify high-risk individuals before it’s too late.

“These blood biomarkers are an important step toward developing blood tests to identify patients with imminent risk of ending their lives,” said corresponding author Dr. Adolfo Sequeira, associate researcher in the Department of Psychiatry & Human Behavior at the UCI School of Medicine in a statement

https://www.zerohedge.com/medical/researchers-closer-creating-blood-test-suicide-risk

Pfizer to Sell Stake in Haleon Following GSK De-Merger

 Next month, GlaxoSmithKline will complete its de-merger, forming two companies, New GSK, a pharma-focused business, and Haleon, a stand-alone consumer health operation. Pfizer, a GSK partner, intends to sell off its stake in the consumer health company when the de-merger occurs.

GSK's consumer health business has been a joint venture with Pfizer. Prior to the two companies forming a consumer health partnership, GSK had once been a contender to acquire Pfizer's consumer health business. However, that deal was scuttled in 2018.

Days after spurning Pfizer's consumer health operations, GSK bolstered its own consumer health business by buying out Novartis' $13 billion stakes. That same year, GSK and Pfizer opted to work together and combine their consumer health businesses into a joint venture. GSK owned the majority share of the joint venture, holding a 68% stake, while Pfizer maintained a 32% share. 

The two pharma-focused companies combined efforts into a business valued at approximately $14 billion in 2020. The combined portfolio that will now be sold under the Haleon name includes household staples such as Advil, Tums, Sensodyne toothpaste, Excedrin and Nicorette gum. 

Now, Pfizer intends to sell its 32% stake in the company. In a brief announcement this morning, Pfizer's sale of its stake will keep with the company's "transformation into a more focused, global leader in science-based innovative medicines and vaccines." Pfizer said it will seek the most advantageous sale of its share of Haleon in order to maximize value for company stockholders. The company did not attach a value to its stake at this time. 

Haleon will be headquartered in Weybridge in the United Kingdom. The consumer health company is expected to attain a premium listing on the London Stock Exchange and will also apply to list American Depositary Shares on the New York Stock Exchange. 

Although Pfizer intends to sell its stake in Haleon after the company formally splits away from GSK, the company will continue to have a connection at the board level. John Young, the former group president and chief business officer of Pfizer and Bryan Supran, senior vice president and deputy general counsel at Pfizer will serve on the Haleon board of directors. 

GSK is expected to continue to hold a stake in Haleon. Last year, GSK Chief Executive Officer Emma Walmsley predicted that the GSK pharma business, which has been dubbed New GSK, will achieve approximately $46 billion in annual sales by 2031. Walmsley also predicted consistent growth of more than 10% operating profit over the next five years. 

https://www.biospace.com/article/pfizer-plans-to-sell-stake-in-haleon-following-gsk-de-merger/

China Elected To World Health Organisation Executive Board With No Objections

 by Steve Watson via Summit News,

China has been elected to the World Health Organisation’s Executive Board with zero objections from any democratic countries, despite its voluminous attempts to cover up the Coronavirus outbreak and its subsequent brutal lockdowns.

Hillel Neuer of the watchdog group UN Watch noted “this is the regime that crushed” warnings from whistleblowers in late 2019 and early 2020.

He also noted that “not a single democracy spoke out to object.”

Spectator columnist Ross Clark commented that the WHO is “stuffed with small countries, many with lousy human rights records, which will not dare to challenge China or which will not have the political clout to do so.”

Lets remember that the head of the World Health Organization’s origin investigation into COVID-19 has admitted that China basically ordered his team on what to write in their report and allowed them to mention the lab leak theory, but only on the condition that they didn’t recommend following it up.

In addition, China has refused to cooperate with the renewed WHO probe, declaring that any attempt to look into the lab leak theory goes “against science” and claiming, contrary to U.S. intelligence and the WHO’s own conclusions, that workers in the lab were hospitalised with COVID in the autumn of 2020.

China’s government run Academy of Sciences also shortlisted the Wuhan bio-lab for its ‘Outstanding Science Achievement’ prize for work with coronaviruses.

Talk about rubbing it in.

Jamie Metzl, a leading advisor for the World Health Organisation itself has stated that China engaged in a “massive cover up” of the coronavirus pandemic.

Metzl also pointed out that the World Health Organisation “doesn’t have the mandate to have its own surveillance capabilities,” and was therefore easily batted away by China in the early days of the outbreak when it requested to send responders.

The WHO, which facilitated China’s draconian response to COVID by insisting the western world impose similar lockdowns, is also now urging that gay pride events go ahead despite the clear risk of them being monkeypox super-spreader events, given that the virus is transmitted through close physical contact.

Awarding China a seat on the WHO Executive Board is like if North Korea was put in charge of the UN Conference on Disarmament…oh wait, they really did that too.

https://www.zerohedge.com/geopolitical/china-elected-world-health-organisation-executive-board-no-objections