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Health

J&J names Joaquin Duato as CEO efficient January 3, changing Alex Gorsky

Johnson & Johnson announced on Thursday evening that Joaquin Duato will become the company’s new CEO effective January 3, replacing previous chairman Alex Gorsky.

Duato will also be appointed to the company’s board of directors following his move to the C-suite role. Previously, he was Vice Chairman of the company’s Executive Committee.

“I have had the pleasure to work closely with Alex for many years and I thank him for his outstanding leadership,” said Duato in a statement. “I am pleased that I will continue to benefit from his guidance and his findings in the future.”

Gorsky, who was CEO for nine years and will now serve as Executive Chairman, said in a statement that “the time is right for me personally as I am more focused on my family for family health reasons.”

Joaquin Duato, Executive Vice President and Worldwide Chairman of Pharmaceuticals at Johnson & Johnson on Tuesday, January 31, 2017.

Andrew Harrer | Bloomberg | Getty Images

Johnson & Johnson shares fell nearly 1% during extended trading.

During Gorsky’s time at the helm, J&J faced a wave of lawsuits over its talc-based baby powder and other products and was named in state opioid lawsuits.

Last month, a group of attorneys general reached a $ 26 billion settlement with three of the country’s largest US drug dealers and J&J after claims the companies fueled the deadly opioid epidemic.

According to the settlement proposal, distributors McKesson, Cardinal Health and AmerisourceBergen are expected to pay a total of $ 21 billion, while J&J is expected to pay $ 5 billion over a nine-year period.

J & J’s vaccine was originally touted as a blessing by federal health officials when it was approved by the Food and Drug Administration in late February, as it only requires one dose and can be stored at refrigerator temperatures for months.

Since then, it has suffered from poor perception of its overall effectiveness, concerns about rare side effects, and production delays.

In April, the FDA announced it was adding a warning label to J & J’s Covid vaccine, listing blood clotting as a rare side effect. In July, the FDA announced it was adding another warning to the J&J label, stating that the shot was linked to a serious but rare autoimmune disease called Guillain-Barre Syndrome.

Reuters contributed to this report.

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Health

Pfizer Covid vaccine 39% efficient in Israel, prevents extreme sickness

People will be given a dose of the Pfizer BioNTech Covid-19 vaccine at a Covid-19 mass vaccination center on Rabin Square in Tel Aviv, Israel on Monday January 4, 2020.

Kobi Wolf | Bloomberg | Getty Images

Pfizer and BioNTech’s Covid-19 vaccine is only 39% effective in Israel, where the Delta variant is the dominant strain, but still offers strong protection against serious illness and hospitalization, according to a new report from the country’s health ministry.

The efficacy figure, based on an unspecified number of people between June 20 and July 17, is down from a previous estimate of 64% two weeks ago and is in conflict with data from the UK that showed the Vaccination was 88% effective against symptoms, disease caused by the variant.

However, the two-dose vaccine still works very well in preventing serious illness, showing 88% effectiveness against hospitalization and 91% effectiveness against serious illness, according to Israeli data released Thursday.

“We have to keep in mind that these vaccines can become less effective over time,” said Dr. Isaac Bogoch, professor of infectious diseases at the University of Toronto.

He stressed that the syringes are still highly effective in preventing serious infections and helping hospital systems not get overwhelmed in the colder months. “We are still in the Covid era and anything can happen,” he said.

“We have to be prepared and we have to be agile that at some point people will need a booster,” he added. “This close monitoring, which is happening in places like Israel, the UK and other parts of the world, will be very helpful in moving policy forward when and when we need boosters.”

The Delta variant, which is already present in more than 104 countries, worries US health officials as they detect more breakthrough infections in fully vaccinated people, even though they are milder.

The Chief Medical Officer of the White House, Dr. Anthony Fauci said people who are fully vaccinated should consider wearing masks indoors as a precaution against the rapidly spreading variant in the US

“Of course we don’t want to see that,” said Fauci on Wednesday, referring to the so-called breakthrough infections. “This virus is very different from the viruses and variants that we have previously experienced. It has an exceptional ability to transmit from person to person.”

Dr. Paul Offit, who advises the FDA on Covid vaccines, said that while the vaccines still offer great protection against serious illness and death, they may not work as well against mild cases or the transmission of the disease to others.

He urged more Americans to get vaccinated, saying Delta was a highly contagious virus and the vaccinations would help people get seriously ill. Currently, less than half of the US population is fully vaccinated, according to data compiled by the CDC.

“This is rich and fertile soil for the virus to continue to reproduce and keep creating variants that may become increasingly resistant to vaccines or natural infections,” he said.

The report from Israel, which began vaccinating its people before many other countries, is likely to back up the arguments made by drug manufacturers that people will eventually need to be given a booster to protect themselves from new variants.

Pfizer said earlier this month that immunity is waning from its two-dose vaccine and is now planning to seek approval from the Food and Drug Administration for a booster dose. However, federal officials say that fully vaccinated Americans do not currently require additional vaccinations.

In a statement to CNBC, Pfizer said it remains confident that its two-dose regimen will protect against the coronavirus and its variants.

Still, it said a third dose might help after analysis from its Phase III study showed a decrease in effectiveness against symptomatic infections after four to six months.

“Initial data from a third dose of the current vaccine shows that a booster dose given at least 6 months after the second dose induces high neutralization titers against wild-type and beta that are 5 to 10 times higher than after two primary doses. “Said the company.

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Health

Novavax says its Covid vaccine is 90% efficient, plans FDA submission in Q3

A woman holds a small bottle with a sticker “Coronavirus COVID-19 Vaccine” and a medical syringe in front of the Novavax logo displayed in this image dated October 30, 2020.

Given Ruvic | Reuters

Biotech company Novavax said Monday its Covid-19 vaccine had been shown to be safe and 90.4% overall effective in a Phase III clinical trial involving nearly 30,000 participants in the United States and Mexico.

In addition, the two-dose vaccine was found to be 100% effective in preventing moderate and severe illness, and 93% effective in some variants. The company plans to file a regulatory filing with the Food and Drug Administration in the third quarter.

The late-stage study “confirms that NVX-CoV2373 has an encouraging tolerability and safety profile,” said Dr. Gregory Glenn, President of Research and Development at Novavax, in a press release. “These data show consistent, high efficacy and reaffirm the vaccine’s ability to prevent COVID-19 amid the virus’ s ongoing genetic evolution.”

With an abundance of vaccines already available in the US, it is possible that the government could donate the Novavax doses to other countries.

The company’s analysis evaluated 77 confirmed Covid infections among the 29,960 participants in the study. Novavax said 63 cases of Covid were seen in the placebo group, up from 14 cases seen in the group that received their two-dose vaccine. That resulted in an estimated vaccine effectiveness of 90.4%, it said.

The vaccine also appeared to be well tolerated, the company said. The most common side effects were fatigue, headache, muscle aches and pain at the injection site, which usually didn’t last more than two or three days, the company said.

All Covid hospital admissions in the study were in the placebo group, the company said.

Novavax said the vaccine appears to be effective against a few variants, including the alpha variant, which was first identified in the UK. About 65% of the cases where sequence data were available were of worrying variants, the company said.

If Novavax’s vaccine is FDA approved, it would follow three Covid-19 vaccines already approved in the U.S. by Pfizer-BioNTech, Moderna, and Johnson & Johnson for emergency use.

The new data comes as federal officials say the U.S. has more than enough doses of Covid vaccine to vaccinate the entire American population. According to the Centers for Disease Control and Prevention, more than 173 million Americans had received at least one dose of a Covid-19 vaccine as of Sunday.

The Biden government has already committed to donating at least 20 million doses of Covid vaccines from Pfizer-BioNTech, Moderna and J&J, and 60 million doses of AstraZeneca’s vaccine, which is not yet approved for use in the United States

Earlier this month, the White House announced it was lifting restrictions under the Defense Production Act, which gives the US priority to vaccines developed by AstraZeneca, Sanofi and Novavax.

Novavax said Monday it is still on track to hit production capacity of 100 million cans per month by the end of the third quarter and 150 million cans per month by the fourth quarter of 2021.

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Health

Moderna Vaccine Extremely Efficient in Adolescents, Firm Says

The authorization of a second vaccine for adolescents could help convince more parents, some of whom have expressed reluctance about having their children vaccinated, that the shots are safe, experts said. “Most parents vaccinate their children,” Dr. O’Leary said. “With the Covid vaccines, we’ve seen a little bit more hesitancy, but the further along we get demonstrating safety and effectiveness, the more people we’re seeing wanting the vaccine.”

It would also give parents and teenagers a choice between vaccines, although experts noted that the Pfizer and Moderna vaccines appear to be equally safe and effective.

“This really give parents, I think, a little bit more confidence,” said Rupali Limaye, an expert on vaccine use and hesitancy at Johns Hopkins University. “If they’ve had personal experience, for example, with one of the mRNA products and not the other, they might feel more comfortable then saying, ‘You know, I had a great experience with Moderna, so I really want my child to get Moderna.’”

But because the Pfizer and Moderna vaccines both require two shots, spaced several weeks apart, ensuring that all teens have access to the vaccine may remain a challenge. “I think we’ll still unfortunately not be able to reach more underserved populations that are facing vaccine disparities, because it’s still the two-dose regimen,” Dr. Limaye said. Authorizing a one-dose vaccine, like the Johnson & Johnson shot, for use in adolescents may help close these gaps, she said.

The U.S. already has enough doses to vaccinate adolescents many times over. There are approximately 25 million American children between the ages of 12 and 17, according to estimates from the U.S. Census Bureau. That is roughly the same number of shots that Pfizer and Moderna are distributing, in total, per week in the U.S.

“Right now, we have more than enough supply to vaccinate our teens,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center in New York. “So it’s not so much that the Moderna vaccine is critical for having supply for our population, but rather, having a second vaccine come online for that age group that could be available to the rest of the world — I think that is important.”

Many other countries, however, will not be ready to vaccinate their adolescents for quite some time. Although more than 1.7 billion vaccine doses have been administered globally, there are enormous inequities between countries; 84 percent of doses have gone to people in high- and upper-middle-income countries. Just 0.3 percent have gone to low-income countries.

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World News

Moderna says shot is 100% efficient in teenagers, plans to hunt FDA OK in June

A young man receives his Covid-19 vaccination in a vaccination clinic. People are receiving the Moderna vaccine in Milford, Pennsylvania.

Preston Ehrler | LightRocket | Getty Images

Moderna said Tuesday that its Covid-19 vaccine was 100% effective in a study in adolescents ages 12 to 17. This makes it the second attempt after Pfizer that has demonstrated a high level of effectiveness in younger age groups.

The company plans to ask the Food and Drug Administration to expand emergency use of its Covid-19 vaccine to teenagers early next month. If approved, it would likely dramatically increase the number of recordings available to middle and high school students before the next school year. Pfizer and German partner BioNTech were approved to use their vaccine for 12 to 15 year olds earlier this month.

“We are encouraged that mRNA-1273 is highly effective in preventing COVID-19 in adolescents,” said Stephane Bancel, CEO of Moderna, in a press release. “We continue to strive to do our part to end the COVID-19 pandemic.”

The two-dose vaccine, given four weeks apart, is already approved for adults.

The phase 2/3 study the company cited on Tuesday included more than 3,700 teenagers. No cases of Covid-19 were observed in participants who received two doses of the vaccine, while four cases were observed in the placebo group, according to the company.

No significant safety concerns have been identified to date, with side effects generally in line with a previous study in adults, the company said. The most common side effects after the second dose were headache, fatigue, muscle pain, and chills, Moderna said.

The new data comes less than three weeks after the company announced in an earnings report that early data showed the shot was 96% effective against Covid in teens ages 12-17. These data were based on those who had received at least one dose of the vaccine.

The company said Tuesday that the shot in the study was 93% effective after one dose. For this it used the definition of Covid-19 from the Centers for Disease Control and Prevention, which only requires one symptom and a positive Covid test.

US regulators are expected to approve Moderna’s application for teenage use. The approval process could take about a month, in time for some summer activities and fall Classes if Moderna submits the data by the beginning of June. Pfizer and BioNTech, for example, filed for expanded use of their shot in teenagers on April 9th ​​and were approved by the FDA on May 10th.

Vaccinating children is seen as critical to ending the pandemic. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, health officials and experts say.

According to the government, children make up around 20% of the total US population. According to medical experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity, and some adults may refuse to get the shots. Although now more experts say herd immunity becomes less likely as variants spread.

According to health experts, vaccinating children can also accelerate the return of personal learning and enable after-school activities such as sports, arts, and other personal activities after school.

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Health

Pfizer and Moderna Pictures Are Powerfully Efficient in opposition to Virus, Evaluation Says

Pfizer-BioNTech and Moderna Coronavirus vaccines are 94 percent effective at preventing symptomatic Covid-19 disease, according to a new study of 1,800 US healthcare workers.

The research the Centers for Disease Control and Prevention published on Friday provides even more evidence that the vaccines work well outside of controlled clinical trials.

“This report provided the most compelling information yet that Covid-19 vaccines are working as expected in the real world,” said Dr. Rochelle Walensky, CDC director, in a statement Friday.

“This study, which was added to the many previous studies, was instrumental in changing the CDC’s recommendations for those fully vaccinated against Covid-19.”

The results are based on an ongoing study of healthcare workers in 25 states. This interim analysis included data on 1,843 healthcare workers who were routinely tested for coronavirus infection. More than 80 percent of the participants were female.

About 623 workers tested positive between January and mid-March. Those who were fully vaccinated were 94 percent less likely to develop symptomatic coronavirus infections than their unvaccinated counterparts, the researchers found. The numbers are consistent with the effectiveness estimates from the clinical studies.

The scientists also found that a single dose of the two-shot regimen was 82 percent effective in preventing symptomatic infection. This number is higher than reported in other studies and may be due to the relative youth of the study participants, who had an average age of 37 to 38 years. Less than 2 percent were 65 years of age or older.

CDC scientists had previously found that fully vaccinated health, frontline, and essential workers were 90 percent less likely to get coronavirus. These results helped allay fears that vaccinated people might even asymptomatically transmit the virus and spread it to others.

Concern was a major reason for asking vaccinated Americans to continue wearing masks, a recommendation the CDC overturned Thursday.

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Health

Pfizer Vaccine Is Extremely Efficient In opposition to Variants, Research Discover

The second new study, published in The Lancet, was carried out by researchers from the Israel Ministry of Health and Pfizer. It is based on more than 230,000 coronavirus infections that occurred in Israel between January 24th and April 3rd. During that period, B.1.1.7 accounted for nearly 95 percent of all coronavirus cases in the country, with more than half of which vaccinated its population.

The researchers found that the vaccine was more than 95 percent effective against coronavirus infections, hospitalizations, and deaths in people aged 16 and over who were fully vaccinated. It also worked well in older adults. Among those 85 years old or older, the vaccine was more than 94 percent effective against infection, hospitalization, and death.

As the percentage of people fully vaccinated increased in each age group, the incidence of coronavirus infections decreased in this cohort, the researchers found. The decline in infection rates was more in line with the timing of increases in vaccine coverage in each age group than the start of a nationwide lockdown. The results suggest that Israel’s rapid pace of vaccination was responsible for the decline in infections in the country.

“I’m just so happy to see this data that these vaccines have such an amazing impact on controlling infection and disease in the real world,” said Akiko Iwasaki, an immunologist at Yale University.

Both studies also reported that two doses of the vaccine provided significantly more protection than one dose. For example, in the Israel study, one dose of the vaccine was 77 percent effective against death, while two doses were 96.7 percent effective.

“It absolutely underscores the need for the second dose,” said Dr. Kathleen Neuzil, who directs the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine.

Taken together, the studies suggest that vaccination remains a plausible way out of the pandemic even with the new variants, experts said. “If we can get vaccines out into the world and improve reporting,” said Dr. Neuzil, “I believe that we can go beyond that and stay up to date on the emergence of new variants.”

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Politics

U.S. to limit journey from India efficient Might four amid huge Covid surge

Individuals wearing personal protective equipment (PPE) wear the body of a person who died of coronavirus disease (COVID-19) during a mass cremation at a crematorium in New Delhi, India on April 26, 2021.

Adnan Abidi | Reuters

Biden’s government will restrict travel from India as that country grapples with a gigantic increase in coronavirus cases, White House press secretary Jen Psaki said on Friday.

The policy will go into effect on Tuesday May 4th, Psaki said in a statement. The administration made the decision based on recommendations from the Centers for Disease Control and Prevention, Psaki said.

The State Department declined to comment on the reported travel restrictions and referred a reporter’s question to the White House.

While Covid infections and deaths in the US are declining as millions of Americans are vaccinated every day, India is in some cases on an unprecedented surge.

India reported a record daily death toll from Covid on Wednesday. The country has reported more than 300,000 new cases every day for more than a week.

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Health

The Pfizer and Moderna vaccines are 94 % efficient at stopping hospitalization in older adults, a examine finds.

Pfizer BioNTech and Moderna coronavirus vaccines prevent 94 percent hospitalization of fully vaccinated adults aged 65 and over, according to a small study published Wednesday by the Centers for Disease Control and Prevention.

The results, which are in line with clinical trial results, are the first real evidence from the US that the vaccines protect against severe Covid-19. Older adults are at the highest risk of being hospitalized and dying from the disease. More than 573,000 people have died from the virus across the country, according to a New York Times database. As of Wednesday, 142.7 million people had received at least one dose of one of three federally approved vaccines, including about 98 million people who were fully vaccinated.

“These results are encouraging and welcome news for two-thirds of people 65 and older who are already fully vaccinated,” said Dr. Rochelle Walensky, CDC director, in a statement. “Covid-19 vaccines are highly effective and these real world results confirm the benefits of clinical trials preventing hospitalizations among the most vulnerable.”

The study is based on data from 417 patients enrolled in 24 hospitals in 14 states between January 1 and March 26. About half were 75 years or older.

Both the Pfizer and Moderna vaccines require two shots three to four weeks apart. Older adults who were partially vaccinated – that is, received a dose of the vaccine more than two weeks earlier – were 64 percent less likely to be hospitalized with the coronavirus than unvaccinated seniors, the researchers reported.

The vaccines did not reduce hospitalization rates in people who received their first dose less than two weeks earlier. It takes time for the body to build an effective immune response, and people are considered fully vaccinated two weeks after the last dose in the series.

“This also underscores the persistent risk of serious illness shortly after vaccination, before a protective immune response has been achieved, and increases the need for vaccinated adults to continue physical distancing and prevention behaviors,” the scientists wrote.

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Health

Vaccines Are Efficient In opposition to the New York Variant, Research Discover

For weeks, New Yorkers have been witnessing the alarming rise of a native variant of the coronavirus that has stubbornly kept the number of cases in the city high. City officials have repeatedly warned that the variant could be more contagious and evade the immune response.

At least on this second point, they can now breathe easier: Both the Pfizer BioNTech and Moderna vaccines will be effective in preventing serious illness and death of the variant, according to two independent studies.

Antibodies stimulated by these vaccines are only slightly less effective in controlling the variant than the original form of the virus, both studies found.

“We don’t see any big differences,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York and a member of the team that published one of the studies on Thursday.

The final result? “Get vaccinated,” he said.

The results are based on laboratory experiments with blood samples from a few vaccinated people and have not yet been assessed by experts. Still, they are consistent with what is known about similar variants, several experts said, and they complement a growing body of research suggesting that the two main vaccines in the United States protect against all of the variants identified so far.

“The takeaway message is that the vaccines against the New York variant and the South African variant as well as the British variant will work,” said Nathan Landau, a virologist at NYU’s Grossman School of Medicine who led the study.

The vaccines spur the body to build an expansive immune response using thousands of types of antibodies and different types of immune cells. A subset of these immune fighters, called neutralizing antibodies, is essential to preventing infection. But even when neutralizing antibodies are in short supply or even absent, the rest of the immune system can deploy enough defenses to fight off serious illness and death.

In both new studies, neutralizing antibodies from people who were vaccinated were able to thwart the virus better than those from people who developed antibodies because they had Covid-19. A head-to-head comparison of the two sets of antibodies offered a possible explanation: Antibodies from vaccinated individuals are spread over a wider range of parts of the virus, so no single mutation has a major impact on their effectiveness – vaccines are therefore a better choice against variants than immunity from natural ones Infections.

The variant first identified in New York, known to scientists as the B.1.526, sped through the city after its first discovery in November. By April 13, it was one in four diagnosed cases, and as of April 13, almost half of the cases. Variant B.1.1.7, which brought Great Britain to a standstill, is also widespread in New York. Together, the two account for more than 70 percent of coronavirus cases in the city.

Concern for the variant identified in New York has centered on a form that contains a mutation that scientists call Eek. The Eek mutation subtly changes the shape of the virus, making it difficult for antibodies to target the virus and, as a result, underperforms vaccines.

Updated

April 23, 2021 at 12:36 AM ET

In the second study, Dr. Landau states that the Pfizer and Moderna vaccines are only marginally less protective against the variant that devastated the UK and against forms of the variant discovered in New York that do not contain the Eek mutation.

Several laboratory studies have shown that antibodies induced by the Pfizer and Moderna vaccines are slightly less effective against a third variant identified in South Africa that also contains Eek. Other vaccines fared worse. South Africa suspended use of the AstraZeneca vaccine after clinical studies showed that the vaccine did not prevent mild or moderate disease of the variant circulating there.

“It already started at a lower level in terms of the immunity it produced,” said Dr. Nut branch about the AstraZeneca vaccine. Regarding the Pfizer and Moderna recordings, he said, “We are so lucky in this country to have these vaccines compared to the rest of the world.”

Florian Krammer, an immunologist at the Icahn School of Medicine on Mount Sinai who was not involved in any of the new studies, said he was more concerned about other countries’ vaccination programs than the variants themselves.

“I’m less worried about variants than I was two months ago,” he said, but added, “I’m worried about countries that don’t have enough vaccines and that don’t have this vaccine launch.” In all honesty, I don’t worry about the US anymore. “

Dr. Landau also tested monoclonal antibodies used to treat Covid-19 against the variants. They found that the cocktail of monoclonal antibodies made by Regeneron was effective against both the variant discovered in New York and the original virus.

The studies are reassuring, but they show that the Eek mutation is being observed, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.

“This could certainly be a step towards making the virus a little more resistant to infection- and vaccine-mediated immunity,” said Dr. Bloom. “I don’t think it’s something people need to be alerted about right away, but it definitely impresses us as important.”

Dr. Bloom led the analysis comparing vaccine-induced antibodies with those produced by natural infections. He found that the strongest antibodies bind to multiple sites in a key part of the virus. Even if a mutation affected binding at one site in that region, antibodies targeting the remaining sites would still be protective.

Antibodies induced by the vaccine cover many more sites in this region than those due to natural infection – and are therefore less likely to be affected by a mutation in any one site.

The study only looked at antibodies stimulated by the Moderna vaccine, but the results for the Pfizer BioNTech vaccine are likely to be the same, he added.

“This could potentially be a good thing as the virus creates mutations,” said Dr. Bloom.