The Food and Drug Administration’s Committee of Independent Expert Advisors on Thursday voted largely in favor of the agency’s approval of Pfizer’s vaccine to protect babies against the common respiratory virus RSV, a respiratory syncytial (sin-SISH-uhl) virus that can be fatal. for babes

The vaccine, tentatively called Abrysvo, is given to pregnant women between 24 and 36 weeks of gestation, allowing protective antibodies to be produced and then cross the placenta to protect the fetus.

In a phase III trial involving nearly 7,400 pregnant women in 18 countries, the vaccine was nearly 82 percent effective in preventing severe RSV in the first 90 days of a child’s life. After 180 days, the effectiveness was 69 percent. In terms of protection against mild respiratory illness caused by RSV, the trial results did not meet the statistical criteria for efficacy at 90 days, but data at 180 days suggests an efficacy of about 51 percent.

In the first of two votes at today’s one-day meeting, FDA advisers voted unanimously 14 to 0 that the efficacy data looked good and suggested the vaccine would protect babies from RSV.

But the security data that was the focus of the second vote got some members thinking. Although the vaccine appeared to be largely safe in pregnant women and infants compared with placebo, data from the phase II and phase III trials contained a weak signal suggesting that vaccination may increase the risk of preterm birth. In the phase III study, there were 201 preterm infants (before 37 weeks) in the vaccination group, while only 169 preterm infants were in the placebo group. Among these early births, 21 in the vaccination group were early preterm births (before 34 weeks), while there were only 12 early preterm births in the placebo group.

Overall, the differences were not statistically significant, and rates of prematurity were lower than those typically seen in the general population. But, as several FDA consultants noted, the phase III trial did not address this signal, even though it had been observed in the earlier phase II trial. There was also an imbalance in where the signal was visible; Pfizer representatives stressed that there was no difference in preterm birth rates among trial participants in high-income countries, including the US.

Anxiety, but mostly excitement

This burst of data alone may not have been enough to raise concerns. But it worried some consultants, who noted that GSK, another pharmaceutical giant, had developed its own RSV vaccine and was facing the same signal. GSK had a vaccine with a similar design and dose that was similarly administered to pregnant women at the same interval of 24 to 36 weeks of gestation. During the Phase III study, GSK found a statistically significant increase in preterm births. and company refused to judge because of this.

When a pharmaceutical company refuses to test, it’s a big deal, Dr. White. Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia, noted in the discussion section of the meeting. “These decisions are never taken lightly,” Offit said.

When the vote came over whether the vaccine safety data were adequate, the results came in 10 to 4, with Ofit among the four who voted no. After the vote, he reiterated that the data provided by Pfizer did not reflect his concerns about GSK’s findings. “If you are in any sense risking preterm birth with this vaccine, I think you will have to pay a heavy price,” he warned.

But most of the panel were less concerned about the uncertainty of the preterm signal, and some expected it to be a statistical anomaly that would disappear as the vaccine was given to more babies. Some members also noted that test data on birth weight and similar rates of developmental delay are reassuring that the vaccine is safe. Pfizer has introduced a post-registration surveillance system to try to track such results.

Overall, many consultants were enthusiastic about the potential of the vaccine. The effectiveness is “very exciting,” said Amanda Cohn, director of the Division of Birth Defects and Childhood Disorders at the Centers for Disease Control and Prevention, voting “yes” on both effectiveness and safety issues. It is “a really important tool for prevention, [I’m] very excited.”

In the US, RSV is one of the leading causes of hospitalization for children under 5 years of age. The CDC estimates that during a typical RSV season, the virus sends 58,000 to 80,000 children under the age of 5 to the hospital, and 100 to 300 die from the infection.

The FDA will now decide whether to approve the vaccine. If it does, the CDC will make recommendations for its use in the US.

Amputees can be made to feel temperature or material changes in their phantom hand, a discovery that could help equip prostheses with a sharper sense of touch.

After an amputation, some people have the feeling that their missing arm or leg is still attached, which is called a phantom limb. To learn more about these limbs, Soleiman Shokur from the Swiss Federal Institute of Technology in Lausanne and colleagues observed 26 people who lost at least part of one arm in an accident and reported that they had phantom hands.

The researchers placed a temperature-controlled device on the residual limbs of these participants. They then applied three temperatures: 25°C (77°F), 32°C (89.6°F), and 37°C (98.6°F), and participants reported whether they could feel warmth in their phantom hands and, if so, if they could distinguish between temperatures.

Seventeen said they felt a change in the temperature of their phantom hand when the device was used, which the researchers called phantom heat sensation. Of these, 15 could distinguish three temperatures. “Our hypothesis is that nerves continue to grow in the skin after amputation,” says Shokur. “By precisely acting on these nerves, we create this phantom sensation.”

It is unclear why only 17 participants reported feeling fever. “We noticed that a lot of people who didn’t respond got into a fire-related accident and so their skin got burnt, and so they may have lost a lot of skin sensitivity,” he says.

In another part of the experiment, the researchers applied the sensor to three materials: glass, copper, and plastic. This sensor was connected to the remaining hands of nine participants with phantom heat sensation, who were blindfolded. It was initially set to 32°C, the approximate skin temperature, and then cooled down at about the same rate as the skin temperature on our hands when it touches copper, glass, or plastic.

The participants identified which of the materials the sensor touched had a 66% chance of success, compared to a 67% success rate when their whole hand touched the materials.

The researchers hope to develop their sensor so that it can be applied to prosthetic fingertips, allowing amputees or hands to detect temperature. According to Shokur, this will help amputees avoid burns, as well as make touching more natural. “One person told me that he would like to wear this device, holding the child’s hand to feel his warmth,” he says.

• The video shows three cheetahs killing and feasting on a waterbuck in Kruger National Park.

• A pair of crocodiles then approach the cheetahs, who hiss and eventually retreat.

• Crocodiles, known as scavengers, then begin to eat waterbucks themselves.

Recent video Footage filmed in South Africa’s Kruger National Park shows crocodiles and cheetahs fighting for the right to eat meat.

The video begins with a trio of cheetahs chewing on a waterbuck, a type of antelope.

But once the cheetahs start digging in, a couple crocodiles Cheetahs collide with crocodiles by dragging their prey away from the approaching crocodiles several times.

Although cheetahs are much faster than crocodiles, the constant intimidation of crocodiles eventually wins them prey. When a larger crocodile gets right up to a waterbuck carcass, the cheetahs back off and slowly back off.

After the crocodiles successfully capture the prey, the video shows more crocodiles rolling onto the feast.

Watch the entire scene unfold in the video below, featured on Latest Observation YouTube Channel:

“A total of 12 crocodiles appeared and went to kill the waterbuck,” said the couple who filmed the video, Bob and Rosa Sworth. according to Earth Touch News Network. “However, in the end, the carcass was left with only the largest crocodile, surrounded by vultures and other scavenging birds.”

Crocodiles in Kruger National Park are Nile crocodiles, the second largest crocodile species in the world. They may be scavengers that will feed on discarded carcasses along with other carnivores, which are usually “tolerant of each other’s presence”. a park.

This time, the feeding cheetahs were not very tolerant.

It is not clear why the cheetahs refused to drag their prey away from the approaching reptiles, although weight could have something to do with it. Medium adult cheetah weighs up to 125 pounds, while the average adult waterbuck can weigh between 350 and 660 pounds, according to to the African Wildlife Fund.

The story goes on

The foundation also describes the cheetah as a “timid predator” as it often loses its prey to thieving lions, leopards, hyenas, vultures and jackals.

According to Krueger, Nile crocodiles have to feed on large carcasses in groups so that they can all hold the dead animal in their jaws to secure it while they take turns unscrewing large pieces.

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