I choose Pfizer’s inventory over Novavax

Seres Therapeutics: “You’re a younger person and you’re new and I think you can buy it. It’s too speculative for an older person because the company doesn’t make any money. I like your call, though.”

ViacomCBS: “It’s okay. I think the whole business is under attack. You can mention any of these. I think it’s just okay. I mean, it’s going well, but it’s just okay.”

Novavax: “They came like gangbusters. We all thought they would be the same. I like Pfizer. Pfizer also comes with the pill. That is the inexpensive way. I feel safe at Pfizer. “

ODP Corporation: “No, I can buy anything I want from Amazon. I don’t need this company. This is an Amazon roadkill.”

GrowGeneration: “Well, we had Grow in our teenage years and then when it got to the 40s and 50s we said, ‘We have enough. We made too much money, don’t be greedy.’ Bulls make money, bears make money, pigs are slaughtered, and we said sell and have never looked back. “

Canopy growth: “At that point, $ 9, I probably would [be a buyer]. My problem here is that this wasn’t a good quarter. It’s not going very well. … I don’t like the cannabis business. I just don’t. I think it was an over the top business, similar to what we’re seeing right now in the gambling business, which is just brutal. “

Palantir: “Cult-Share, Cult-Share, Cult-Share. The cult-shares don’t work, OK?

Context logic: “We actually think this company is a decent company and they are throwing it away. I mean, you buy it for $ 3, can it go to zero? I think so, but it’s good [speculative play]. “

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CDC director defends controversial name on Pfizer’s Covid boosters

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, insisted Friday that she did not override a vaccine advisory committee by getting approval from the CDC for Pfizers Covid boosters are supposed to accept a proposal that has been rejected by the committee.

In an unusual move, Walensky broke out of the CDC’s Advisory Committee on Immunization Practices, which on Thursday voted 9 to 6 against approving vaccines for those in high-risk environments.

Walensky adopted the other recommendations of the panel Distribute third syringes to adults with pre-existing conditions and to anyone aged 65 and over. She said the final vote to release additional doses for teachers, health workers and other key employees was a “scientific scarcity”.

“I want to be very clear that I have not overridden an advisory committee,” said Walensky at a Covid briefing in the White House on Friday. “I have listened to all of the FDA advisory committee proceedings and listened carefully to this extraordinary group of scientists who spent hours publicly and very transparently on some of these very difficult questions and where the science stood.”

Dr. Rochelle Walensky, selected as director of the Centers for Disease Control and Prevention, speaks during an event at The Queen Theater in Wilmington, Del., Tuesday, December 8, 2020.

Susan Walsh | AP

Walensky’s directive is closely based on that of the Food and Drug Administration Verdict on boosters Wednesday. This agency similarly defied the advice of its scientific advisory board by authorizing the recordings for a wider audience than it was advocating Advisory Committee on Vaccines and Related Biological Products.

“This was a scientific scarcity,” said Walensky, noting the lengthy two-day meeting and robust debate. “It was my call. If I had been in the room I would have voted yes.”

She tried to build public confidence by encouraging people to go back and listen to the committee’s deliberations. “We made it public, we made it transparent, and we did it with some of the best scientists in the country,” she added.

Dr. Paul Offit, an infectious disease doctor at Philadelphia Children’s Hospital and a voting member of the FDA’s advisory committee, turned down boosters for young people fearing they could cause myocarditis. Offit called Walensky’s expansion of the ACIP recommendation “a first,” adding that he felt Pfizer should have conducted more extensive booster studies before submitting its results to the FDA and CDC.

“As a healthy person under 30, I would wait and see how that goes,” Offit told CNBC. “Wait for a few million cans to get out of there.”

But with the US recording a seven-day average of 2,011 deaths per day on Thursday, 6% more than a week ago, according to a CNBC analysis of data from Johns Hopkins University, other doctors support Walensky’s decision.

Adjusting the panel’s guidelines was Walensky’s responsibility, even if it broke the precedent, said Dr. Arturo Casadevall, Chair of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health.

“These committees are advisory,” said Casadevall. “Ultimately, this is a matter of policy, and politics requires judgment.”

President Joe Biden said at a briefing Friday that the CDC’s recommendation had widened the boosters to roughly 60 million Americans, including educators, health workers and supermarket employees. The broader booster criteria better protect frontline workers and account for the vaccine delivery inequalities that affect people of color, Walensky said.

“I am also aware of the disproportionate impact of this pandemic on racial and ethnic minority communities,” Walensky said. “Many of our frontline workers, key workers, and those in meeting places come from communities that are already hardest hit.”

She said denying these groups access to boosters will only exacerbate inequalities in the pandemic, which have caused black and Hispanic Covid patients to die more often than whites.

More than 55% of the US is fully vaccinated, and more than 2.4 million Americans have received boosters since the agency approved them for people with compromised immune systems on Aug. 13, according to the CDC.

Walensky said the agency will work to evaluate the booster data from Quickly Modern and Johnson & Johnson In the coming weeks.

“We intend to have numerous advisory boards at the CDC to review many pending decisions, including Moderna, J&J, and pediatric vaccinations,” said Walensky.

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.

FDA panel recommends Pfizer’s Covid booster doses for individuals 65 and older

An influential advisory committee to the Food and Drug Administration on Friday rejected a proposal to distribute booster vaccinations from Pfizer and BioNTech Covid-19 Vaccine to the general public and scaled back those plans, unanimously recommending the third vaccination to people 65 and older and other at-risk Americans.

“In my opinion it is likely to be beneficial for the elderly and eventually could be indicated for the general population. I just think we’re not there yet in terms of the data, ”said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

The panel voted 16-2 against distributing the vaccines to Americans 16 and older before unanimously adopting an alternative plan to give boosters to older Americans and those at high risk of developing serious illness if they got the virus receive. This previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

Pfizer stock closed 1.3% while BioNTech’s shares fell 3.6%.

The non-binding decision of the FDA’s Advisory Committee on Vaccines and Related Biological Products comes as the Biden government announced that it would begin offering booster vaccinations to the general public as early as next week pending approval from US health regulators . Although the agency has not always followed the advice of its committee, it often does. A final FDA decision could be made in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third syringes in the United States

“We’re not tied to your voice at the FDA just for you to understand. We can adjust this as needed,” recalled Dr. Peter Marks, the agency’s top vaccine regulator, joined the panel after the votes. He asked the group for suggestions on what other populations the FDA should consider for boosters, such as frontline health workers and other professions exposed to higher levels of exposure to Covid.

It was expected that the committee vote would be controversial, as some scientists included two senior FDA Officials involved in Friday’s meeting said they were not entirely convinced that every American who received the Pfizer vaccine now needs extra doses.

White House senior medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t recommend the shots for anyone 16 and older. Fauci, who publicly supported Booster, hesitated in an interview on Friday “Closing bell“To guess what the committee would ultimately decide.

“I don’t want to pre-empt the advisory committee at the time they are deliberating,” he said.

Liesl Eibschutz, a Dartmouth University medical student, loads a syringe of Pfizer COVID-19 vaccine before giving the vaccine on the first day people 16 and older get the vaccine at Kedren Health on Thursday, Angeles, California.

Allen J. Cockroaches | Los Angeles Times | Getty Images

In published a paper Days before the advisory committee meeting, a leading group of scientists said the available data showed that vaccine protection against serious illnesses persists, even as efficacy against mild illness wears off over time. The authors, including two senior FDA officials and several World Health Organization scientists, argued Monday in the medical journal The Lancet that widespread use of booster syringes to the general public is currently inappropriate.

In the outlines of the plans for last month’s launch Distribute booster next week, Biden administration officials cited three CDC studies showing that vaccine protection against Covid has waned over several months. Senior health officials said at the time they feared protection from serious illnesses, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

Before the vote, some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third shot should be limited to specific groups, e.g. illness. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.

Dr. Hayley Gans, a voting member, said she was “concerned” that the FDA asked the committee to review the entirety of the evidence presented Friday because some data, including on safety, were still inadequate.

Another member, Dr. Paul Offit said he would support boosters for people over 60 but struggled to support a third vaccination for younger groups due to a higher risk of myocarditis.

Ahead of Friday’s vote, the committee listened to several presentations on data supporting the widespread use of booster vaccinations, including by health officials in Israel, where officials began vaccinating the country’s population before many other countries and their citizens later July.

Phil Krause, an FDA vaccine regulator and co-author of The Lancet, criticized the results presented Friday, saying that much of the data had not been federally vetted or peer-reviewed. He said the models used are complex and scientists need to make sure they are “getting the right results.”

“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.

In documents released by the FDA on Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30, when the rapidly expanding delta variant emerged across the country.

In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. Health officials began to see a trend that people in their 40s and 50s who were fully vaccinated became seriously ill with Covid.

“We didn’t want to wait for these results and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”

She also said the booster was well tolerated by many people, citing data showing that out of approximately 2.9 million people who received the additional doses, there was only one case of myocarditis, a rare inflammation of the heart that occurred with mRNA vaccines.

Pfizer’s booster side effects are also similar to those seen after receiving the second dose of vaccine, said Dr. Joohee Lee, an officer with the FDA’s Office of Vaccines Research and Review, during the meeting.

Of the 289 booster recipients, ages 18 to 55 years old, observed in Pfizer’s Phase 3 study, 63.8% developed fatigue, 48.4% headache, and 39.1% muscle pain. The FDA examined side effects in 2,682 recipients of Pfizer’s second dose of Covid aged 16 to 55 years and reported fatigue in 61.5% of patients, headache in 54%, and muscle pain in 39.3%. One adverse event – swelling of the lymph nodes – occurred in 5.2% of booster recipients but only 0.4% of those who received their first two doses.

“The majority were mild to moderate and they resolved,” Lee said of the lymphadenopathy cases. “Though one is reported to be underway right now.”