Velandy Manohar, MD.,
Distinguished Life Fellow- Am. Psychiatric Association.
Medical Director- CT. Aware Recovery Care
11 28 21
… Nov.13 2021
Some CDC officials have noted that young, healthy people may not need additional protection yet, the newspaper reported. They’ve also said that focusing on booster shots may distract from the effort to get unvaccinated people to start their vaccine series.
“CDC officials will await FDA regulatory action before announcing next steps,” Kristen Nordlund, a CDC spokeswoman, told reporters this week.
Even so, many senior health officials have voiced their support. Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases; Vivek Murthy, MD, the U.S. surgeon general; and David Kessler, MD, chief science officer for the White House COVID-19 Response Team, have previously talked about their strong support of booster shots for all adults. [Dr. Rochelle Walensky, MD, director of the CDC, has expressed caution about making the additional shots widely available until all the data is in and FDA decides first followed by the CDC Vaccine Advisory Committee makes their recommendation to Dr. R. Walensky, MD.VM]
At about 9:10PM on 11 29 21 the interview with Dr. David Kessler, MD begins. He is a former FDA Commissioner. He`s now the Chief Science Officer for the White House`s COVID-19 response.
I have all these questions. You may have some of these questions as well. I am prepared to be talked out of the feeling in my stomach about this variant, but I`ve got these questions to ask before I`m going to let that happen.
Luckily, I`m very pleased to say, joining us now is Dr. David Kessler. He is a former FDA commissioner. He`s now the chief science officer for the White House`s COVID-19 response.
Dr. Kessler, it`s always an honor to have time with you. Thank you for being here tonight, particularly on a night when so many Americans have basic questions about this new variant.
DR. DAVID KESSLER, FORMER FDA COMMISSIONER: Fire away, Rachel. I`m ready the answer all your questions. [He has made massive contributions on food safety and transparency about the nutritional value and potential for harm accrued by consuming food available across the USA and the World.VM]
MADDOW: All right, thank you. You exactly know what I`ll be talking to.
Let me just ask you the first question that I ask. We have had it described to us, this new variant, as having a very large number of mutations, a large number of mutations specifically affecting the spike protein, which has been a real target for the development of our vaccines.
Can you tell us why a large number of mutations is worrying? Why that`s bad? Why the spike protein mutations themselves might be worrying or bad?
KESSLER: We have some experience with some of those mutations because we`ve seen some of those mutations in other variants, and those mutations can affect transmissibility and they can affect how well our vaccines work.
Look, there is a lot we still need to learn. We need to learn about transmissibility against delta, the severity, how well the vaccines and therapeutics will perform. There is early data from South Africa that suggested there`s increased transmissibility of the Omicron variant, but we should not jump to any conclusions. This is still very early days with this variant.
Ask your next question.
MADDOW: Well, in terms of what you just said about how -- about figuring out whether it`s susceptible to vaccines and whether or not it`s responsive to antiviral or antibody treatment, how long do you think it will be before we have answers to those questions about the effectiveness of the vaccines and also the treatment question?
KESSLER: With regard to the effectiveness of vaccines, I would expect we would probably need at least two weeks in therapeutics I guess we`re about four weeks. We`re setting up the assays. I talk to a number of laboratories. We have to get the virus or make a pseudo virus so we can handle it and test it, so we will know what exactly the effectiveness is. But we need two to four weeks to get those answers.
MADDOW: And what about the treatment options that we`ve got?
KESSLER: Very important. You know, we have two important sets of treatment options -- monoclonals, that you and I have talked about, and we have a number of monoclonals.
I think there may be a differential response. We have to be prepared that not each one of the monoclonals will work exactly the same. Some may work well. Others may drop out.
With regard to the antivirals, and none of those are yet authorized. FDA`s got to consider the first one tomorrow. [DEC 1st] You and I have talked about these, and you and I understand the importance of antivirals, certainly in HIV. And I do think they can be a game changer.
The good news is there doesn`t appear to be significant mutations that would affect how those antivirals work, but again, we have to see.
MADDOW: If there is bad news in terms of the effectiveness to the vaccines, if it appears that this variant defeats the vaccines essentially or evades them in some way, and new vaccines or boosters need to be developed, is the new mRNA technology that led to the Moderna and Pfizer vaccines such that those new vaccines or new boosters could be made quickly? And by asking it in those terms, I guess I should ask you to tell me how quickly.
KESSLER: The answer is yes; we have the tools to handle this. We can do this quickly. Again, let`s not jump to any conclusions, but you know us, Rachel. We are planning and planning for all these scenarios, and again, no decisions have been made but if and when we need to do that, we`re probably several months before we can have enough vaccines.
But relatively short period of time, nothing like the first go around. We can do this quickly. We have the tools.
MADDOW: Why is the CDC telling us now we should get our booster of our existing vaccines now before we know if those existing vaccines work well against this variant? Or do we know enough about the way they work to think they might be partially effective even if we don`t have a complete picture yet?
KESSLER: Very well said. We know from every variant that we have dealt with that the more neutralizing antibodies you have on board, the more effective those vaccines are against variants, and we expect, even if it`s not perfect, certainly the more neutralizing antibodies, the fact that you`re boosted, the greater protection you can have.[This is what I was speaking about the higher the circulating titers of the [nAb] Neutralizing Antibodies to Covid-19
Let me step back for a second because I just want to -- look, I understand the concern. I understand the need for vigilance. But let me deal with that knot in your stomach. I think that the -- to be very direct, the biggest problem I have tonight, it`s not the variant. It`s about getting everyone vaccinated and boosted. [This is critical for us to advocate for and encourage among our staff in very State
You are right, there is news tonight -- CDC upped its recommendations. Everyone 18 and over should get boosted. If you are sitting out there tonight and you have been vaccinated but not boosted, this is the time.
It certainly is not going to hurt. It will likely help. We`ll see how much it will help, but please go get boosted and certainly if you haven`t been vaccinated, that`s our biggest battle. Getting everyone vaccinated, that`s where we`re going to save the most lives.
MADDOW: If this variant that we`re talking about does somehow change the contours of the -- of the epidemic in this country, of the pandemic globally, one of the things that we`re going to need to know is whether our testing regime still makes sense. Is there any difference in -- effectiveness of our tests for something like this. But we`ll also need to know very basically, and I think that`s part of what I think freaked a lot of people out -- certainly freaked me out reading the reports from the WHO this weekend was the prospect that eventually, whether it`s not this, whether this variant or some on the future, is one of these variant going to be more deadly? Is it going to something that you get worse symptoms, you`re more likely to get very sick, you`re more likely to get killed by one of these things?
It seems we don`t know whether or not this variant has that kind of a difference with the wild type or the other variants that we`ve seen. But I think part of the reason that we all got worried is it feels like if this thing is going to keep mutating in a way that changes so much about the way we have to deal with it, including vaccines and all these things, is it going to mutate in a way that`s going the make it profoundly more dangerous to humanity?
KESSLER: We have a lot more tools. We are in a very different place today than where we started. But, you know, you raise an important point.
We are learning more about how these -- where these viruses mutate. One of the things that`s of concern, but it`s also good news but we really have to attend to is something you and I dealt with -- go back 20 years ago. Immunocompromised people wherever they are can incubate the virus for months on end, and their immuno-suppression needs to be treated.
So, for example, if you have HIV, you need to be treated with your antiviral drugs. So, we have a -- we know a lot more, so we can, with therapy, decrease the chance of these variants from happening in the future. But it`s going to take a lot of work, Rachel.
MADDOW: Dr. Kessler, in terms of where we are right now and you and the team at the White House and the upper levels of the Biden administration, I know this is an area of intense concern, and it`s not like you were slacking on the job on the COVID pandemic and trying to get everyone vaccinated.
Bottom line, do you feel like we`re going to have to change course significantly as a country as this variant emerges, as future variants emerge, or do we keep applying the same tools the same way we have been in because even as the problem seems to get more complex and more virologically interesting, the ways we have to defeat it effectively stay the same.
KESSLER: We have to tools to handle this. We may have to fine tune the tools; we may have to adapt those tools. We do not have to change our course.
We are going to have to make sure that we can convince each other to take advantage of those tools. Those tools of vaccination, of boosting, and, you know, I hope the antivirals that we see -- I don`t want to get ahead of FDA in the coming weeks, but I think they can be game changers.
I think the good news is we have additional tools to our armamentarium. Let`s just use the tools we have wisely.
MADDOW: Dr. David Kessler is the chief science officer for the White House`s COVID-19 response. He`s a former FDA commissioner. Dr. Kessler, as I said, it is always an honor to have your time, especially on a night when I think so many Americans have so many questions. Thank you so much, sir.
KESSLER: Thank you, Rachel.
MADDOW: I should underscore what Dr. Kessler said about the FDA advisory group tomorrow, considering the first of those two antiviral pill. These treatments going to the FDA for potential approval. The first one is the Merck pill, which is going to the FDA adviser panel tomorrow.
After that will be the Pfizer one, which has shown even more effectiveness in clinical trials. That will be an important addition to what we`ve got fight this scourge.
All right. We`ve got a lot more ahead tonight. Stay with us.
This Is When We'll See a "Sharp Jump" in COVID Cases, Virus Expert Warns
By Kali Coleman NOVEMBER 30, 2021
Ashish K. Jha, MD, Dean of the Brown University School of Public Health, said in a series of tweets on Nov. 29 that the country's current drop in cases is not because fewer infections are occurring right now. Instead, Jha explained that this is a common pattern after holidays. "It's what we see during every holiday: drops in cases due to drops in testings. And it's a problem," he tweeted.
Jha added that some of the drop can be explained by officials lagging on reporting cases due to the holiday, but most of it is people not getting tested—even if they're sick. "A lot of it is sick people not getting tested. That's a problem because with less testing, more infected people are spreading to others," he tweeted. "And what we've seen? Bigger the drop during the holiday, bigger the bounce that follows."
According to the virus expert, the U.S. has seen a 25 percent drop in cases overall this Thanksgiving holiday, which is much larger than what we saw last Thanksgiving. With that in mind, Jha said we should expect to see more COVID cases popping up soon, with some being old cases that are a part of the reporting catchup but a "large chunk" being new infections.
"We should expect, a sharp jump in reported infections later this week," he tweeted. "So don't be surprised if cases jump above 100k/day and deaths [over] 1k/day.
Many health officials and virus experts have their worries set on the new Omicron variant, which could potentially spread more easily than previous variants and evade existing vaccines. It will take researchers weeks to determine how serious Omicron is, but according to Jha, that's all the more reason to remain focused on what we know is a problem right now.
"Whatever happens with Omicron, the variant killing Americans right now is Delta," Jha tweeted. "And we can stop it with vaccines, testing, [and] key public health measures."
If you are not vaccinated children 5-18 - get vaccinated one or both shots depending on the type of vaccine.
If you have received one or both shots as recommended for the specific Vaccine- and you are above 18 seek a booster dose especially if you immune compromised, work in high risk environments, or are first responder and above age 65 particularly if you have comorbid Psychiatric Illness and Chronic health Problems TIIDM, COPD, Congestive Heart Failures, Obesity.
WHO Chief Scientist Dr. Soumya Swaminathan, MD.,says omicron 'quite infectious', must not panic
Francesco Guarascio and Stephanie Nebehay, Reuters
Published: 03 Dec 2021 08:03 PM BdST Updated: 03 Dec 2021 08:03 PM BdST
World Health Organization (WHO) Chief Scientist Soumya Swaminathan attends a press conference organised by the Geneva Association of United Nations Correspondents (ACANU) amid the COVID-19 outbreak, caused by the novel coronavirus, at the WHO headquarters in Geneva Switzerland July 3, 2020. Fabrice Coffrini/Pool via REUTERS
The World Health Organization's chief scientist Soumya Swaminathan told Reuters on Friday that while the new coronavirus variant omicron appeared to be very transmissible, the right response was to be prepared, cautious and not panic.
The WHO has urged countries to boost healthcare capacity and vaccinate their people to fight a surge in COVID-19 cases driven by the omicron variant, saying travel curbs could buy time but alone were not the answer.
"How worried should we be? We need to be prepared and cautious, not panic, because we're in a different situation to a year ago," Swaminathan said during an interview at the Reuters Next conference.
While the emergence of the new variant was unwelcome, she said the world was much better prepared given the development of vaccines since the start of the COVID-19 pandemic.
Much remains unknown about omicron, which was first detected in southern Africa last month and has been spotted in at least two dozen countries. Parts of Europe were already grappling with a wave of infections of the Delta variant before it emerged.
"We need to wait, lets, hope it's milder ... but it's too early to conclude about the variant as a whole," Swaminathan said of what was known about omicron.
"Delta accounts for 99% of infections around the world. This variant would have to be more transmissible to out-compete and become dominant worldwide. It is possible, but it's not possible to predict."
The WHO's top scientist said the omicron variant seemed to be causing three times more infections than experienced previously in South Africa, meaning "it does seem to be able to overcome some of the natural immunity from previous infection".
Vaccines did appear to be having some effect.
"The fact that they're not getting sick .... that means the vaccines are still providing protection and we would hope that they would continue to provide protection," Swaminathan said.
Asked about the need for annual vaccine boosters, she said "the WHO is preparing for all scenarios", which could include an additional dose, particularly among some age groups or vulnerable sections of the population, or a modified vaccine.
"Natural infection acts as a booster," the WHO scientist said, adding that while the new variant "could have originated in a country where there isn't a great deal of genome sequencing", its origins were not known.
"We may never know," Swaminathan said.
[In the past I have corresponded with her about the ethical concerns with regard to the Emergency approvals of and setting of priorities for the administration of vaccination among people at risk of being infected and getting more ill and needing hospitalization and at risk of fatal outcomes. We also have some shared experiences with the Medical Institutions in Chennai, Tamil Nadu in India that she shares with my sister and me.VM]
Velandy Manohar, MD.,
Medical Director, CT- Aware Recovery Care