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Dr. Scott Gottlieb on Pfizer’s efforts on a 3rd Covid vaccine shot

Pfizer board member Dr. Scott Gottlieb told CNBC on Thursday that the company is researching two different methods to provide vaccination protection against new coronavirus variants.

In an interview on Squawk Box, Gottlieb said the first approach focused on whether a booster shot using the current formulation of the two-dose vaccine would provide additional defense. Pfizer and its German partner BioNTech announced a test that was not examined until early Thursday.

“There is reason to believe that just boosting the existing vaccine against these new variants will give you extra protection,” said Gottlieb, a former Food and Drug Administration commissioner in the Trump administration.

The second endeavor is to modify the existing vaccine so that stronger immunity to virus mutations can be achieved, explained Gottlieb. The companies announced in a press release on Thursday that they are discussing the launch of this research study with regulators.

While new coronavirus variants affect public health officials, particularly the contagious strain first found in South Africa, Gottlieb said any change to the vaccine formulation would offer broad protection.

“What you want to do is not necessarily develop a vaccine that is specifically against [B.1.351], the change we’ve seen in South Africa, “said Gottlieb, who headed the FDA from 2017-2019.” You want to develop a protein sequence that is sort of a consensus sequence and that incorporates enough of the changes we’ve seen around the world that you have a vaccine that protects no matter what the virus does against itself. “

It is widely believed that the virus variant discovered in South Africa poses a greater challenge to existing vaccines than other new strains, such as the one originally discovered in the UK

For example, Johnson & Johnson reported that their vaccine was 72% effective in preventing symptomatic Covid in the US and 57% in South Africa, where the B.1.351 strain dominates. However, the vaccine provided 85% protection against severe Covid throughout the trial. Part of this has also been carried out in regions of Latin America where different variants exist.

The U.S. FDA is expected to use J & J’s vaccine soon after the agency’s emergency vaccine board meeting scheduled for Friday.

Pfizer-BioNTech and Moderna vaccines, which already have an emergency approval in the US, were tested in large phase three studies before the new variants were discovered. However, Pfizer and BioNTech conducted a study examining the variant found in South Africa. This indicated some reduction in antibody production, even though the vaccine was still neutralizing the virus.

In addition, Moderna has said that its two-dose vaccine appears to produce a weaker immune response against the South African variant, while adding that the antibody response remains at levels believed to provide protection.

Moderna announced Wednesday that it has shipped an optimized version of its vaccine to the National Institutes of Health to start various studies on variant protection. Similar to Pfizer, the company will also be testing a lower-dose booster shot of its current two-dose formulation.

Limited available doses have been a barrier to covid shots being given to more people once government approval has been granted. In the U.S. in particular, that situation has improved as companies ramp up production, and Gottlieb noted that J & J’s possible approval of the single-dose vaccine will also help expand access.

Should a booster shot be needed to ensure better protection against variants, Gottlieb was confident that the dosage might be available. “I don’t think we have to ration supplies if we want to give people a third booster in the fall,” he said.

“The challenge will be to think about the new vaccine variant and whether and when you would switch to this vaccine and how much you would produce,” said Gottlieb. “That will be a decision you need to make before these new variants of vaccines are likely to get approved. You may not want to switch all of your manufacturing, but you want to switch some of it.” He added, “You will likely have to make that decision sometime this summer.”

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

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Health

Recipients cannot let guard down, says Dr Scott Gottlieb

Dr. Scott Gottlieb on Thursday warned coronavirus vaccine recipients not to abandon their guards immediately and urged CNBC to adhere to public health measures such as wearing masks.

The former commissioner for the U.S. Food and Drug Administration said the advice is especially important to older Americans who are at higher risk of death or serious illness from Covid-19.

“I think for an elderly person who is susceptible to this virus, wait some time after the second shot until you probably have full protective immunity,” Gottlieb told Squawk Box. “I don’t think people should feel completely safe after the first shot.”

Both Covid vaccines, which have received emergency clearance from the FDA, require two doses. Pfizer and its German partner BioNTech developed one of the vaccines while Moderna makes the other. Gottlieb is on the Pfizer board of directors.

Around 10.3 million Americans received their first Covid shot on Wednesday morning, according to the Centers for Disease Control and Prevention. About 29.4 million cans were distributed.

The shaky vaccine comes as the nation continues to see high levels of coronavirus infections and more deaths from Covid-19. According to a CNBC analysis of the data compiled by Johns Hopkins University, the 7-day average of new daily cases in the country is 245,306. An average of 3,360 Americans have died of Covid each day in the past week. This is the second highest number ever recorded.

Vaccine recipients still need to take public health precautions as the US outbreak remains so significant and “infections are everywhere,” Gottlieb said. “If you are a vulnerable person, it is still very advisable to continue wearing a mask and taking precautions even after you had the second shot and believe you have complete protective immunity to the vaccine.”

“That doesn’t mean you have to hibernate and avoid seeing family,” added Gottlieb, who headed the FDA in the Trump administration from 2017 to 2019. “Maybe you can lean forward in this regard but wear a mask. Be more careful with these interactions, because in a high-circulation environment you are still at risk.”

With more and more Americans being vaccinated, Gottlieb should lower overall infection rates in the United States and significantly reduce the intensity of the epidemic. At this point, he said it made more sense to “loosen” some precautions.

“Hopefully this will be summer, spring, when these new variants fail to gain a foothold here in the US and change our trajectory,” he said, referring to the coronavirus strains originally found in the UK and South Africa believed to be more transmissible.

Researchers in Ohio said Wednesday they had discovered two new variants that likely originated in the United States

Last week, Gottlieb warned Americans that a return to pre-pandemic life was unlikely in 2021. For example, he told CNBC that public places may still require that the temperature be taken before entry.

“I just think that if you drive through an airport now after 9/11, things will be different, just as they are,” he said last week. “I don’t think masks will be mandatory next fall and winter when we can increase the vaccination rate and when these new varieties go away or don’t prevail. But I think a lot of people will want to wear masks, and that’s fine. “

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. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.

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MacKenzie Scott Proclaims $4.2 Billion Extra in Charitable Giving

In her brief career as one of the world’s foremost philanthropists, MacKenzie Scott has made a name for herself for the sheer volume and speed of her donations, donating nearly $ 6 billion in her fortune this year alone.

Ms. Scott, a writer who was once married to Amazon founder and CEO Jeff Bezos, announced in a Medium post Tuesday that she’d given nearly $ 4.2 billion to 384 organizations over the past four months have. Many of the groups are focused on basic needs for millions of people during a difficult year, including food banks and meals on wheels.

“This pandemic has been a wrecking ball in the lives of Americans who have already struggled,” Ms. Scott wrote. “Economic losses and health consequences were worse for women, people of color and people living in poverty alike. Meanwhile, it has significantly increased the wealth of the billionaires. “

Mainstays like NAACP, Easterseals, Goodwill and United Way were on the list. This also applies to more than 100 separate YMCA and YWCA organizations across the country which, like many nonprofits, have lost tremendous revenue even though the demand for their services has increased.

And smaller organizations like a nonprofit affordable home lender in Minnesota and a group helping people pay off medical debts also received funding.

Ms. Scott’s post did not include the amounts paid to each organization, but it did say that the full amount pledged is prepaid and unrestricted or “no commitment” as she put it.

Morgan State University, a historically black university in Baltimore, announced it had received $ 40 million, the largest private gift in the institution’s history. Ms. Scott said the money went to groups in all 50 states, Washington and Puerto Rico.

Chuck Collins, director of the Charity Reform Initiative at the Institute for Policy Studies, said he couldn’t think of anyone who gave away more this year, at least in terms of publicly announced grants. “She’s responding to the current moment with urgency,” said Mr. Collins.

“They think of all of these tech achievements, they are the big disruptors, but it disrupts the norms surrounding billionaire philanthropy by moving fast and not creating a private foundation for their great-grandchildren to give away the money,” added Collins.

The Institute for Political Studies has pushed for legislation that will double the amount of money foundations will have to pay from 5 percent a year to 10 percent for the next three years to meet the yawning needs caused by the pandemic.

For context, the Gates Foundation, in many ways the largest and most influential nonprofit in the world, raised $ 5.1 billion in direct grants with the fortunes of both Microsoft founder Bill Gates and investor Warren E. Buffett. Dollars awarded in 2019. However, the Gates Foundation has decades of experience and more than 1,600 employees, while Ms. Scott only referred to a team of advisors to help her find good causes.

While the Gates Foundation may donate more than $ 5.9 billion through its Covid-19 response, the number shows how quickly Ms. Scott has risen to become the number one donor worldwide.

In July, Ms. Scott announced that she had donated $ 1.7 billion to historically black colleges and universities, as well as groups promoting women’s rights, LGBTQ equality and the fight against climate change, among others. Howard University said at the time it had received $ 40 million, a donation it described as “transformative”.

When Ms. Scott and Mr. Bezos were divorced last year, Ms. Scott received 4 percent of Amazon’s outstanding shares, or 19.7 million shares. They were valued at around $ 38.3 billion at the time. Those stocks would be valued at approximately $ 62 billion today after a pandemic-triggered surge in Amazon stocks. It’s not clear how many stocks she sold.