Dr. Scott Gottlieb says Merck’s Covid capsule ‘could make an actual distinction’

DR. Scott Gottlieb explained why he is so optimistic Merck‘S Covid antiviral pill after drug maker asked Food and Drug Administration on Monday to approve his pill to treat people with mild to moderate symptoms of Covid.

“The topline data from this Merck study were probably the best treatment effects we’ve seen with oral antiviral drugs in the treatment of respiratory pathogens.

If the agency picks up the drug, it will be the first pill proven to work against Covid-19, and Americans could get it by the end of the year.

Gottlieb told CNBCs “The News with Shepard Smith” The Merck pill is part of an “overall, significant improvement in our therapeutic toolkit against this virus, not just with vaccines and therapeutics, but with more accessible diagnostic tests.”

Host Shepard Smith also asked Gottlieb about masking rules across the country. Gottlieb told Smith that he believes decisions are made locally, noting the uneven prevalence of the Delta variant in the US

“We’ve seen sharp declines in the south, where most of the delta runs, so cases are falling very sharply in populous states like Texas and Florida, but you’re seeing pretty dense epidemics in the Midwest and the simple states, and we me I still don’t know how the Northeast and the Northern States will fare, “said Gottlieb.

He predicted that a Covid-19 delta wave could hit the northern US states despite higher vaccination rates and higher previous infection rates.

“I still think there is a delta wave that will sweep across the northern states, including the northeast,” said Gottlieb.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

Gottlieb says FDA approval for younger youngsters by Halloween potential

Aidan Mohl, 13, will be born on November 11th.

Christopher Aluka Berry | Reuters

Dr. Scott Gottlieb told CNBC on Wednesday that it is still possible for the Food and Drug Administration to grant approval Pfizer and BioNTechCovid-19 vaccine for young children by Halloween.

“I wouldn’t rule out the possibility that this could come out in October,” said Gottlieb, who sits on Pfizer’s board of directors and served as FDA commissioner in the Trump administration for two years.

Pfizer submitted an initial Covid Vaccine study data for children ages 5 to 11 with the FDA on Tuesday, and the company should file a formal application for emergency approval “shortly,” Gottlieb said in an interview Wednesday “Squawk Box.”

The Food and Drug Administration has a lot of experience with the Pfizer vaccine, noted Gottlieb, adding that the Covid vaccination is for young children the same two-dose regimen like adults, but given in smaller amounts. The agency has already approved the recordings for Americans aged 12 and over.

“You saw a lot of clinical data,” he said. “I’ve said for a long time that October is a possibility, but it’s an optimistic possibility. If it fails, it could fall by mid-November.”

Gottlieb’s comments come a day after the Wall Street Journal reported that regulatory clearance of the Pfizer vaccine for children ages 5-11 may not come before November.

Last week, Pfizer released new data showing that in a clinical study in children ages 5-11 years old, a two-dose 10 micrograms dose – one third of the dose for adolescents and adults – is safe and elicits a “robust” immune response .

Pfizer was expected to apply for emergency approval to use the vaccine in young children by the end of this month, but now the company says it will apply “in the coming weeks”.

That could mean the footage might not be available until November, when the FDA spends as much time reviewing the data for this age group as it does for 12-15 year olds. Pfizer and BioNTech filed for expanded use of their syringe in adolescents on April 9th ​​and were approved by the FDA on May 10th.

A Pfizer spokesman declined to comment on an approval schedule, saying the company couldn’t speculate on exactly when the FDA would make a decision on whether or not to approve the vaccine’s use.

“We are still on track to formally apply for EEA very soon,” Jerica Pitts told CNBC.

Approval couldn’t come sooner as children are starting the new school year, the Delta variant spills across America, and many parents are anxious to get their younger children vaccinated. The stress has led to an increase in hospital admissions in the United States, including among young children that currently cannot be vaccinated.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

Dr. Scott Gottlieb weighs in on Pfizer’s Covid booster approval course of

Former Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb told CNBC that he believed the Centers for Disease Control and Prevention could soon provide more clarity on who is eligible for Covid booster doses.

Gottlieb, a Pfizer Board member, explained the FDA and CDC booster approval process in an interview on Tuesday at “The news with Shepard Smith. “The FDA could make a formal decision via Pfizer’s boosters before the CDC begins a two-day series of meetings on Wednesday and Thursday at which Gottlieb said health officials could expand the FDA’s instructions.

“They provide physicians and patients with detailed guidance and interpret the recommendations of the Food and Drug Administration,” Gottlieb said of the CDC. “For example, they could say they could enumerate the types of severe conditions that would qualify someone for a refresher.”

An FDA advisory committee rejected a plan on Friday that would have allowed a third dose for all Americans 16 and older, and raised reservations about insufficient data and the risk of myocarditis. But the committee then voted unanimously in favor of the approval of boosters for the medically weak and everyone over 65 years of age.

Gottlieb said the process had given conflicting messages about who should be eligible for boosters, but added that he always thought the FDA was holding two votes to narrow down potential recipients of a third Pfizer dose.

“I think the meeting gave the impression that there could be contradicting messages. I don’t think that is the case,” said Gottlieb. “The FDA initially voted on boosters for the entire age group 16 and over and finally agreed on a recommendation that boosters should be made available for people 65 and over and for those at risk of severe Covid disease, a higher one Risk from the disease itself. That always seemed to be the FDA’s goal, administrative. “

Dr. Scott Gottlieb, former Commissioner of the Food and Drug Administration, speaks during the Skybridge Capital SALT New York 2021 conference in New York City, the United States, on September 15, 2021.

Brendan McDermid | Reuters

Gottlieb added, “I think it gave the impression that the agency voted out Booster before they voted for it – that wasn’t the case. It was more of an administrative measure and I think this has caused some public confusion. “

As Pfizer awaits final approval of its boosters, vaccine makers will Modern and Johnson & Johnson both released data warranting approval of their own add-on doses. J&J said Tuesday that its Covid boosters are 94% effective when injected two months after the first dose, while Moderna reported fewer breakthrough cases in recently vaccinated participants in a study published on Sept. 15.

According to the CDC, more than 2.2 million people in the United States have received a booster vaccination since August 13.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of Norwegian Cruise Line Holdings ′ and Royal Caribbean’s Healthy Sail Panel.

Absolutely distant college yr as a result of Covid ‘doable’ with out mitigation ways, says Dr. Gottlieb

DR. Scott Gottlieb warned Covid-19 could again force schools to remain completely remote amid concerns potential outbreaks in the fall in the classrooms.

“Unfortunately, it’s possible, especially if you go into this school year without the kind of mitigation we introduced last year,” Gottlieb, the former FDA chief in the Trump administration, told CNBCs “The News with Shepard Smith”

“We cannot expect fewer measures to be taken to contain infection in schools and the same outcome to keep infection at bay.”

The American Academy of Pediatrics found that children 15% of all new Covid cases last week. Gottlieb recommended Covid containment tools for schools such as masking, placing children in defined social groups, routine tests, and retrofitting air filter systems.

Gottlieb pointed out to host Shepard Smith that schools shouldn’t “take their foot off the break” if the goal is to stay open.

“This is a much more contagious variety, it could be a lot harder to control in school so the goal should be to keep schools open and try to keep these measures going until we see how it goes,” said Gottlieb.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

The epidemic will sweep throughout the U.S. at totally different occasions, Dr. Scott Gottlieb says

DR. Scott Gottlieb told CNBC that it expects the rising US coronavirus cases associated with the highly communicable Delta variant to decline in just a few weeks.

“Probably in two or three weeks, I think we’ll probably be about three weeks behind the UK,” said the former FDA chief in the Trump administration.

“The United Kingdom is clearly downhill… I would expect some of the southern states that were really the epicenter of this epicenter to begin to change in the next two or three weeks. “

While the epidemic is still spreading to the southern states, The rate of expansion shows signs of slowing down. Gottlieb told “The News with Shepard Smith” that the slowdown is a sign that these southern states may be peaking.

However, Gottlieb cautioned that the northern states could start seeing more delta spreads if rates drop in the south.

“Here in this country it will now be much more regionalized. I don’t expect the density of delta expansion in states like New York or Michigan to be as high as in the south,” said Gottlieb. “We have more immunization, we had more pre-infections up there, but you’re going to see cases increase, even in states that have a lot of immunization, just probably not as severe.”

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

New Covid research hints at long-term lack of mind tissue, Dr. Scott Gottlieb warns

Dr. Scott Gottlieb warned on Thursday of the potential for long-term brain loss related to Covid, citing new study from the UK.

“In short, the study suggests that there could be long-term loss of brain tissue from Covid, and that would have some long-term consequences,” said the former FDA chief and CNBC employee.

“You could compensate for that over time, so the symptoms of it may go away, but you will never regain the tissue if it is actually destroyed by the virus,” said Gottlieb, who is the board member of the Covid vaccine manufacturer Pfizer.

The UK study looked at brain imaging before and after coronavirus infection, specifically looking at the potential effects on the nervous system.

Gottlieb explained it to CNBC’s “The News with Shepard Smith” that the destruction of brain tissue could explain why Covid patients have lost their sense of smell.

“The decrease in the amount of cortical tissue happened by chance in regions of the brain that are near the places responsible for the odor,” he said. “What it suggests is that the odor, the loss of smell, is just an effect of a more primary process that is going on, and that process is actually the shrinking of the cortical tissue.”

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotechnology company Illumina.

Rise in adolescent Covid hospitalizations is reflection of latest variants, Gottlieb says

Dr. Scott Gottlieb pointed out the highly transferable Covid-19 variants as a possible cause on Friday an increase in adolescents’ hospitalizations with the virus in March and April.

“It’s worrying the trends in hospitalization” among teenagers, said Gottlieb, the former head of the Food and Drug Administration during the Trump administration. “I think it’s a reflection of the new, more contagious varieties.”

“We see that these variants are more contagious in all age groups, so they affect more adults, but also more children as a result, especially B. 117,” Gottlieb told CNBC “The news with Shepard Smith.”

The B. 117 variant is currently the most widespread strain in the United States with 20,915 reported cases the Centers for Disease Control and Prevention.

In the first three months of the year, CDC researchers found that almost a third of adolescents hospitalized with Covid had to be admitted to an intensive care unit. In the meantime, 5% required invasive mechanical ventilation. Of course, CDC data shows that no teenagers died from Covid in the US in the first quarter of 2021.

CDC director Rochelle Walensky urged parents on Friday to vaccinate their teenagers against Covid, citing more teenagers hospitalized with Covid.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotechnology company Illumina.

Gottlieb says instances will decline, vaccinations monumental achievement

New cases of Covid-19 are falling sharply in the US as millions of people are vaccinated every day. This fuels optimism that the nation may have averted the surge in infections in other parts of the world and is finally turning the corner for worse outbreaks worldwide.

As of Saturday, the 7-day average daily new cases fell below 50,000 for the first time since October and is down 17% from the previous week, according to a CNBC analysis of data from Johns Hopkins University. Hospital stays and deaths due to the disease are also decreasing.

The cases are falling as more Americans get vaccinated. To date, more than 100 million people in the US have been fully vaccinated against Covid-19. according to to the Centers for Disease Control and Prevention or to almost a third of the population. Approximately 146 million people, or 44% of the population, have received at least one dose of vaccine.

Former Food and Drug Administration Commissioner Scott Gottlieb said Sunday that the steep decline in new Covid-19 cases in the US is likely to continue and predicted a “relatively calm summer in terms of the spread of coronavirus” .

“Look, the situation in the US continues to improve, and I think the decline in cases will accelerate in the coming weeks,” Gottlieb said on CBS News’ Face the Nation.

The doctor credited the mass vaccination campaign launched under President Donald Trump and continued under President Joe Biden to help stem the spread of the disease.

The rate of vaccine administration has decreased somewhat In the past few weeks, after having stood up for months, most of the people who were most likely to want a shot got one. However, Gottlieb said that continued vaccination, even in a slower location, will lower virus transmission.

“This was a monumental achievement – the introduction of this vaccine, the vaccination of so many Americans – and it will go on,” said Gottlieb. “We will keep working on it. The vaccination rate will slow down in the coming weeks. But we will continue to take in more people when we come into the summer.”

Dr. Anthony Fauci, White House Pandemic Advisor, recommended last week he expected a “significant reduction in the number of infections per day and a significant reduction in all parameters, namely hospitalizations and deaths” in a few weeks.

The CDC has revised its public health guidelines and said fully vaccinated people can attend small outdoor gatherings without wearing a mask.

“Today is another day when we can take a step back to normal,” said CDC director Rochelle Walensky during a press conference on the announcement. “When you are fully vaccinated things are much safer for you than those who are not fully vaccinated.”

Celebrating the fall in cases, Biden predicted that Americans could potentially get together with friends and family to celebrate July Fourth.

“After a long, tough year, this will make this Independence Day very special – where we not only mark our independence as a nation, but also begin to mark our independence from this virus,” he said in March.

Cities and states have moved in different paces in response to advances in controlling the spread of Covid-19. New York City Mayor Bill de Blasio said he intends to fully reopen the city on July 1. A prospect some experts thought plausible, while Governor Andrew Cuomo said he hoped the city could open even sooner.

Optimism has spread to the stock market, where US indices have hit near record highs.

To get a feel for what might be coming up for the US, Gottlieb said it might be helpful to check out heavily vaccinated San Francisco.

“About 71% of the people in San Francisco had at least one dose of the vaccine, 47% were fully vaccinated. They record about 20 cases a day. You have about 20 people hospitalized,” Gottlieb said.

“They have dramatically reduced Covid in this city and it is largely the result of vaccinations,” he added.

From a financial point of view, Gottlieb suggested that the profits from vaccination were “stalled” and “fairly sustainable”.

“We are entering warm months in which this will create a setback against the spread of the coronavirus, and we are securing these profits,” said Gottlieb.

More than 577,000 people have died of Covid-19 in the United States and more than 32 million have been infected. In December and January, health officials reported an average of more than 200,000 new infections per day.

Even if the health situation in the USA is on the verge of normal, it is deteriorating in other countries with fewer resources. In India, new daily events exceeded 400,000 on Saturday, a record.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotech company Illumina. He is also co-chair of the Healthy Sail Panel for Norwegian Cruise Line Holdings and Royal Caribbean.

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New CDC masks steerage is complicated, however the appropriate step: Scott Gottlieb

DR. Scott Gottlieb said on Wednesday that the Centers for Disease Control and Prevention needs to update their data faster Coronavirus Guidelines if the pandemic situation improves.

A day earlier, the US health department had issued new, relaxed instructions on the need for fully vaccinated people to wear masks outdoors.

“The guidance the CDC has issued is a step in the right direction in my opinion, but it is relatively confusing,” Gottlieb, a former commissioner for the Food and Drug Administration, told CNBC “Squawk Box.” “It is not very clear what they prescribe. I think we need simpler rules if we want to prescribe something about society.”

People who have been fully vaccinated – two weeks after their final dose – can safely exercise and go to small outdoor gatherings without wearing a face mask, according to the new CDC guidance. However, the agency recommends that those who are fully vaccinated continue to wear masks when attending a crowded outdoor event, such as an outdoor event. B. a parade, a sports game or a concert.

The CDC also said that if those other participants are fully vaccinated, it is safe for unvaccinated Americans to forego wearing a mask while attending a small outdoor gathering with friends and family.

The CDC needs to better define what it wants to achieve at this stage of the pandemic when national infection rates are falling and more than 54% of adults in the US have received at least one dose of vaccine, said Gottlieb, who sits on the board of directors at Covid’s vaccine maker Pfizer.

“I think the public health goal should be to try to protect vulnerable populations in gathering environments. So keep focusing on nursing homes, day care centers where young children live, and trying to prevent major outbreaks and overarching events to prevent.” he said.

Approximately 68% of US citizens age 65 and older are fully vaccinated. according to CDC dataAbout 82% of the most vulnerable population received at least one dose.

“We won’t be able to prevent a single rollout where a single person spreads a virus to a single person, but against the backdrop of the decline [coronavirus] Prevalence, rising vaccination rates and more vulnerable Americans protected by vaccinations, we have to lean forward, “said Gottlieb, who headed the FDA in the Trump administration from 2017 to 2019.

The 7-day average of new coronavirus cases per day in the US is around 53,800, according to a CNBC analysis of Johns Hopkins University data. That is 17% less than a week ago.

The US has an average of 676 new Covid deaths per day based on a seven day moving average. This is evident from CNBC’s analysis of the Johns Hopkins data. This corresponds to a decrease of 6% compared to a week ago.

Gottlieb, the beginning of this week called for the end of the requirements for external maskssaid he was concerned about the impact of the CDC, which continues to be overly careful with its guidelines.

“I think the risk to CDC as an institution – it’s a hugely important institution – is that it will lose its relevance and people will stop listening,” he said, warning those in the US to the coronavirus guidelines establish.

“The challenge is that if we do not lift these restrictions with the same speed and efficiency that we have placed on them, we will lose credibility as public health officials to reintroduce them in the future because more of the rest of the world People will worry that this is the case. ” a one-way street, “he said.

The CDC did not immediately respond to CNBC’s request for comment.

Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion Inc., and biotech company Illumina. He is also co-chair of the Healthy Sail Panel for Norwegian Cruise Line Holdings and Royal Caribbean.

U.S. doubtlessly dealing with ‘perpetual an infection’ of Covid, says Gottlieb

Dr. Scott Gottlieb emphasized the importance of getting as many people as possible vaccinated and warned of a potentially bad spring and summer without protective immunity, as new variants of Covid are emerging worldwide.

“If we can’t achieve a more protective immunity in the population, we could face a situation where we have some kind of ongoing infection in the spring and summer as those variants take root here,” said the former FDA chief in the Trump- Administration in an interview on CNBCs “The News with Shepard Smith” on Thursday evening.

Ohio State researchers found A new strain of Covid in the US with mutations that scientists have never seen before. They also revealed that they had found a different strain identical to the highly communicable one from the UK. The researchers say these mutations “likely make the virus more contagious”.

Gottlieb warned that the variants could turn a relatively quiet spring and summer into a summer when we have more infections because these variants are now in circulation and spread more easily even in the warm months when we shouldn’t . I didn’t spread a lot of coronavirus. “

Long-time professor at Harvard University, Dr. David Edwards, echoed Gottlieb’s views on the timing and importance of an effective vaccine rollout.

“Time is of course important when facing an organism,” said Edwards, founder of FEND, a nasal hygiene mist designed for the coronavirus pandemic. “Our main goal this winter should still be to vaccinate as many people as possible with the very powerful vaccines we have today.”

The US distributed 30.6 million vaccines and placed 11 million of them in the arms of the people Centers for Disease Control and Prevention. A ensemble However, the forecast made by the CDC predicted an additional 92,000 Americans will die from Covid over the next three weeks.

The United States has suffered 8,400 deaths in the past two days and nearly 40,000 deaths in less than two weeks of 2021.according to a CNBC analysis of Johns Hopkins data. The pandemic kills an average of more than 3,300 Americans a day.

Gottlieb said host Shepard Smith that he is “encouraged” by Johnson & JohnsonOne-dose vaccine and “confident” in the company’s ability to scale manufacturing to support Covid vaccine rollout in the US

“The early data looked encouraging,” said Gottlieb. “One of the things we saw in the data was that the antibody response continued to rise even after about two and a half months.”

Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, the genetic testing startup Tempus, and the biotech company Illumina. Pfizer has a manufacturing contract with Gilead for remdesivir. Gottlieb is also co-chair of Norwegian Cruise Line Holdings‘ and royal caribbean“Healthy sailing panel”.