The Next Big COVID Variant Could Be a Triple Whammy Nightmare

https://www.yahoo.com/news/next-big-covid-variant-could-100250868.html

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Even as daily new COVID cases set all-time records and hospitals fill up, epidemiologists have arrived at a perhaps surprising consensus. Yes, the latest Omicron variant of the novel coronavirus is bad. But it could have been a lot worse.

Even as cases have surged, deaths haven’t—at least not to the same degree. Omicron is highly transmissible but generally not as severe as some older variants—“lineages” is the scientific term.

We got lucky. But that luck might not hold. Many of the same epidemiologists who have breathed a sigh of relief over Omicron’s relatively low death rate are anticipating that the next lineage might be much worse.

The New Version of the Omicron Variant Is a Sneaky Little Bastard

Fretting over a possible future lineage that combines Omicron’s extreme transmissibility with the severity of, say, the previous Delta lineage, experts are beginning to embrace a new public health strategy that’s getting an early test run in Israel: a four-shot regimen of messenger-RNA vaccine.

“I think this will be the strategy going forward,” Edwin Michael, an epidemiologist at the Center for Global Health Infectious Disease Research at the University of South Florida, told The Daily Beast.

Omicron raised alarms in health agencies all over the world in late November after officials in South Africa reported the first cases. Compared to older lineages, Omicron features around 50 key mutations, some 30 of which are on the spike protein that helps the virus to grab onto our cells.

Some of the mutations are associated with a virus’s ability to dodge antibodies and thus partially evade vaccines. Others are associated with higher transmissibility. The lineage’s genetic makeup pointed to a huge spike in infections in the unvaccinated as well as an increase in milder “breakthrough” infections in the vaccinated.

That’s exactly what happened. Health officials registered more than 10 million new COVID cases the first week of January. That’s nearly double the previous worst week for new infections, back in May. Around 3 million of those infections were in the United States, where Omicron coincided with the Thanksgiving, Christmas, and New Year holidays and associated traveling and family gatherings.

But mercifully, deaths haven’t increased as much as cases have. Worldwide, there were 43,000 COVID deaths the first week of January—fewer than 10,000 of them in the U.S. While deaths tend to lag infections by a couple weeks, Omicron has been dominant long enough that it’s increasingly evident there’s been what statisticians call a “decoupling” of cases and fatalities.

“We can say we dodged a bullet in that Omicron does not appear to cause as serious of a disease,” Stephanie James, the head of a COVID testing lab at Regis University in Colorado, told The Daily Beast. She stressed that data is still being gathered, so we can’t be certain yet that the apparent decoupling is real.

Assuming the decoupling is happening, experts attribute it to two factors. First, Omicron tends to infect the throat without necessarily descending to the lungs, where the potential for lasting or fatal damage is much, much higher. Second, by now, countries have administered nearly 9.3 billion doses of vaccine—enough for a majority of the world’s population to have received at least one dose.

Omicron Shows the Unvaccinated Will Never Be Safe

In the United States, 73 percent of people have gotten at least one dose. Sixty-two percent have gotten two doses of the best mRNA vaccines. A third have received a booster dose.

Yes, Omicron has some ability to evade antibodies, meaning the vaccines are somewhat less effective against this lineage than they are against Delta and other older lineages. But even when a vaccine doesn’t prevent an infection, it usually greatly reduces its severity.

For many vaccinated people who’ve caught Omicron, the resulting COVID infection is mild. “A common cold or some sniffles in a fully vaxxed and boosted healthy individual,” is how Eric Bortz, a University of Alaska-Anchorage virologist and public health expert, described it to The Daily Beast.

All that is to say, Omicron could have been a lot worse. Viruses evolve to survive. That can mean greater transmissibility, antibody-evasion or more serious infection. Omicron mutated for the former two. There’s a chance some future Sigma or Upsilon lineage could do all three.

When it comes to viral mutations, “extreme events can occur at a non-negligible rate, or probability, and can lead to large consequences,” Michael said. Imagine a lineage that’s as transmissible as Omicron but also attacks the lungs like Delta tends to do. Now imagine that this hypothetical lineage is even more adept than Omicron at evading the vaccines.

2022’s Hottest New Illness: Flurona

That would be the nightmare lineage. And it’s entirely conceivable it’s in our future. There are enough vaccine holdouts, such as the roughly 50 million Americans who say they’ll never get jabbed, that the SARS-CoV-2 pathogen should have ample opportunities for mutation.

“As long as we have unvaccinated people in this country—and across the globe—there is the potential for new and possibly more concerning viral variants to arise,” Aimee Bernard, a University of Colorado immunologist, told The Daily Beast.

Worse, this ongoing viral evolution is happening against a backdrop of waning immunity. Antibodies, whether vaccine-induced or naturally occurring from past infection, fade over time. It’s not for no reason that health agencies in many countries urge booster doses just three months after initial vaccination. The U.S. Centers for Disease Control and Prevention is an outlier, and recommends people get boosted after five months.

A lineage much worse than Omicron could evolve at the same time that antibodies wane in billions of people all over the world. That’s why many experts believe the COVID vaccines will end up being annual or even semi-annual jabs. You’ll need a fourth jab, a fifth jab, a sixth jab, et cetera, forever.

Israel, a world leader in global health, is already turning that expectation into policy. Citing multiple studies that showed a big boost in antibodies with an additional dose of mRNA and no safety concerns, the country’s health ministry this week began offering a fourth dose to anyone over the age of 60, who tend to be more vulnerable to COVID than younger people.

That should be the standard everywhere, Ali Mokdad, a professor of health metrics sciences at the University of Washington Institute for Health, told The Daily Beast. “Scientifically, they’re right,” he said of the Israeli health officials.

If there’s a downside, it’s that there are still a few poorer countries—in Africa, mostly—where many people still struggle to get access to any vaccine, let alone boosters and fourth doses. If and when other richer countries follow Israel’s lead and begin offering additional jabs, there’s some risk of even greater inequity in global vaccine distribution.

“The downside is for the rest of the world,” Mokdad said. “I’m waiting to get my first dose and you guys are getting a fourth?”

The solution isn’t to deprive people of the doses they need to maintain their protection against future—and potentially more dangerous—lineages. The solution, for vaccine-producing countries, is to further boost production and double down on efforts to push vaccines out to the least privileged communities.

A sense of urgency is key. For all its rapid spread, Omicron has actually gone fairly easy on us. Sigma or Upsilon might not.

Pregnancy and The Covid Vaccine

Pregnancy and The Covid Vaccine | The Incidental Economist

Pregnancy can be a scary time for many reasons, one of which is having so many things feel off-limits for the safety of the fetus. But what about vaccines? Especially the Covid-19 vaccine? To understand the answer to this question you need data about the vaccine in pregnancy, but you also need data about lacking protection from Covid-19 in pregnancy. Fortunately, we discuss both in this episode!

Omicron variant ‘almost certainly’ not more severe than Delta, Fauci tells AFP

https://www.france24.com/en/live-news/20211207-omicron-variant-almost-certainly-not-more-severe-than-delta-fauci-tells-afp

 Top US scientist Anthony Fauci said Tuesday that while it would take weeks to judge the severity of the new Covid-19 variant Omicron, early indications suggested it was not worse than prior strains, and possibly milder.

Speaking to AFP, President Joe Biden’s chief medical advisor broke down the knowns and unknowns about Omicron into three major areas: transmissibility, how well it evades immunity from prior infection and vaccines, and severity of illness.

The new variant is “clearly highly transmissible,” very likely more so than Delta, the current dominant global strain, Fauci said.

Accumulating epidemiological data from around the world also indicates re-infections are higher with Omicron.

Fauci, the long-time director of the National Institute of Allergies and Infectious Diseases (NIAID), said lab experiments that tested the potency of antibodies from current vaccines against Omicron should come in the “next few days to a week.”

On the question of severity, “it almost certainly is not more severe than Delta,” said Fauci.

“There is some suggestion that it might even be less severe, because when you look at some of the cohorts that are being followed in South Africa, the ratio between the number of infections and the number of hospitalizations seems to be less than with Delta.”

But he added it was important to not over-interpret this data because the populations being followed skewed young, and were less likely to become hospitalized.

“I think that’s going to take another couple of weeks at least in South Africa,” where the variant was first reported in November, he said.

“As we get more infections throughout the rest of the world, it might take longer to see what’s the level of severity.”

Fauci said a more transmissible virus that doesn’t cause more severe illness and doesn’t lead to a surge of hospitalizations and deaths was the “best case scenario.”

“The worst case scenario is that it is not only highly transmissible, but it also causes severe disease and then you have another wave of infections that are not necessarily blunted by the vaccine or by people’s prior infections,” he added.

“I don’t think that worst case scenario is going to come about, but you never know.”

PFIZER AND BIONTECH PROVIDE UPDATE ON OMICRON VARIANT

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-omicron-variant

Pfizer shot provides partial omicron shield, study finds | The Japan Times
  • Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage) while two doses show significantly reduced neutralization titers
  • Data indicate that a third dose of BNT162b2 increases the neutralizing antibody titers by 25-fold compared to two doses against the Omicron variant; titers after the booster dose are comparable to titers observed after two doses against the wild-type virus which are associated with high levels of protection
  • As 80% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, two doses may still induce protection against severe disease
  • The companies continue to advance the development of a variant-specific vaccine for Omicron and expect to have it available by March in the event that an adaption is needed to further increase the level and duration of protection – with no change expected to the companies’ four billion dose capacity for 2022

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccinees one month after receiving the booster vaccination (third dose of BNT162b2 vaccine) neutralized the Omicron variant to levels that are comparable to thoseobserved for the wild-type SARS-CoV-2 spike protein after two doses.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211208005542/en/

Sera from individuals who received two doses of the current COVID-19 vaccine did exhibit, on average, more than a 25-fold reduction in neutralization titers against the Omicron variant compared to wild-type, indicating that two doses of BNT162b2 may not be sufficient to protect against infection with the Omicron variant. However, as the vast majority of epitopes targeted by vaccine-induced T cells are not affected by the mutations in Omicron, the companies believe that vaccinated individuals may still be protected against severe forms of the disease and are closely monitoring real world effectiveness against Omicron, globally.

A more robust protection may be achieved by a third dose as data from additional studies of the companies indicate that a booster with the current COVID-19 vaccine from Pfizer and BioNTech increases the antibody titers by 25-fold. According to the companies’ preliminary data, a third dose provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron. These antibody levels are associated with high efficacy against both the wild-type virus and these variants. A third dose also strongly increases CD8+ T cell levels against multiple spike protein epitopes which are considered to correlate with the protection against severe disease. Compared to the wild-type virus, the vast majority of these epitopes remain unchanged in the Omicron spike variant.

“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Ensuring as many people as possible are fully vaccinated with the first two dose series and a booster remains the best course of action to prevent the spread of COVID-19.”

“Our preliminary, first dataset indicate that a third dose could still offer a sufficient level of protection from disease of any severity caused by the Omicron variant,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Broad vaccination and booster campaigns around the world could help us to better protect people everywhere and to get through the winter season. We continue to work on an adapted vaccine which, we believe, will help to induce a high level of protection against Omicron-induced COVID-19 disease as well as a prolonged protection compared to the current vaccine.”

While these results are preliminary, the companies will continue to collect more laboratory data and evaluate real-world effectiveness to assess and confirm protection against Omicron and inform the most effective path forward. On November 25, the companies started to develop an Omicron-specific COVID-19 vaccine. The development will continue as planned in the event that a vaccine adaption is needed to increase the level and duration of protection against Omicron. First batches of the Omicron-based vaccine can be produced and are planned to be ready for deliveries within 100 days, pending regulatory approval. Pfizer and BioNTech have tested other variant-specific vaccines as well, which have produced very strong neutralization titers and a tolerable safety profile. Based on this experience the companies have high confidence that if needed they can deliver an Omicron-based vaccine in March 2022. The companies have also previously initiated clinical trials with variant-specific vaccines (Alpha, Beta, Delta & Alpha/Delta Mix) and data from these studies will be submitted to regulatory agencies around the world to help accelerate the process of adapting the vaccine and gaining regulatory authorization or approval of an Omicron-specific vaccine, if needed. The companies have previously announced that they expect to produce four billion doses of BNT162b2 in 2022, and this capacity is not expected to change if an adapted vaccine is required.

About the Pfizer-BioNTech Laboratory Studies

To evaluate the effectiveness of BNT162b2 against the Omicron variant, Pfizer and BioNTech immediately tested a panel of human immune sera obtained from the blood of individuals that received two or three 30-µg doses of the current Pfizer-BioNTech COVID-19 vaccine, using a pseudovirus neutralization test (pVNT). The sera were collected from subjects 3 weeks after receiving the second dose or one month after receiving the third dose of the Pfizer-BioNTech COVID-19 vaccine. Each serum was tested simultaneously for its neutralizing antibody titer against the wild-type SARS-Cov-2 spike protein, and the Omicron spike variant. The third dose significantly increased the neutralizing antibody titers against the Omicron strain spike by 25-fold. Neutralization against the Omicron variant after three doses of the Pfizer-BioNTech COVID-19 vaccine was comparable to the neutralization against the wild-type strain observed in sera from individuals who received two doses of the companies’ COVID-19 vaccine: The geometric mean titer (GMT) of neutralizing antibody against the Omicron variant measured in the samples was 154 (after three doses), compared to 398 against the Delta variant (after three doses) and 155 against the ancestral strain (after two doses). Data on the persistence of neutralizing titers over time after a booster dose of BNT162b2 against the Omicron variant will be collected.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

The omicron variant: The ‘good,’ ‘bad,’ and ‘ugly’ scenarios

https://www.advisory.com/daily-briefing/2021/11/30/omicron-future

Will there be a winter lockdown? Experts set out three scenarios - the good,  the bad and the ugly

Déjà vu.

That’s what we felt when news broke about a new coronavirus variant, named omicron, being designated as a variant of concern.” It’s been nearly two years since Covid-19 was declared a global pandemic, and we’re yet again wondering what the future holds.

Once again, there are no clear answers. But we do know enough to begin mapping out the space of possibilities.

We know enough to ask, as we have at past moments in the pandemic: What are the (relatively) “good,” “bad,” and “ugly” scenarios? 

Full disclosure: Even in the day it took us to draft this post, we’ve had to rethink our beliefs in light of emerging information. Still, even if these predictions are shaky, we believe there’s value in reflecting on the futures that could arise—and how health care stakeholders can prepare for each one.

The (relatively) ‘good’ scenario: Our existing vaccines and treatments still work, and omicron doesn’t cause worse disease.

It would be misguided to label any outcome as truly “good” in a pandemic that has already killed more than 775,000 Americans and more than 5 million people worldwide.

Still, some possible futures are clearly better than others—and the best-case scenarios are those in which the omicron variant doesn’t fundamentally change the course of the pandemic.

America has already given 74% of people aged 5+ at least one vaccine dose. If those vaccines are as effective against omicron as other variants, that will be a promising sign for the pandemic’s future.

It’s even possible that omicron’s emergence could drive increased vaccine and booster uptake, as happened in the initial weeks of the delta surge. It could even advance efforts to vaccinate the world, a task that President Biden deemed a “moral obligation” in his early remarks on the omicron variant.

So how likely are current vaccines to work against the omicron variant? One reason for optimism is that most early cases and hospitalizations in South Africa appear to have occurred in unvaccinated individuals. Another is that vaccines have worked well against all past variants, including delta. Still, experts caution that omicron carries more mutations than past variants, and many of those mutations exist in areas associated in lab experiments with immune escape. In the coming weeks, we’ll have more data on whether the vaccines protect against the variant.

Another “good” possibility would that omicron doesn’t make people as sick as other variants (or, put more formally, that it’s not especially virulent). Here, too, there’s reason for optimism. Early reports out of South Africa indicate that most infected individuals have suffered only minor or asymptomatic illnesses.

But there’s also reason for caution: Because the variant has emerged so recently, it’s possible that most cases simply haven’t had time to progress to hospitalization and death. According to WHO, there’s simply no evidence to suggest that omicron’s symptoms are any better or worse than those caused by past variants.

On the whole, we think a relatively good scenario remains plausible, especially in highly vaccinated regions. Additionally, our current preparedness measures—like increased testing and vaccinations, as well as even renewed calls from Dr. Francis Collins from the NIH for mask wearing indoors—may help us get ahead of omicron’s spread, at least in the U.S. But there’s also a risk that things will turn worse.

The ‘bad’ scenario: Omicron is highly transmissible and slightly more virulent than previous variants, but existing vaccines and treatments still work well.

In the “bad” scenario, the omicron variant’s course could look very similar to that taken by the delta variant in the summer. It could rapidly spread throughout the nation and world, with the most severe impacts on unvaccinated populations.

Transmissibility could be a key factor in this scenario, and data on the variant’s basic reproduction ratio (R0) a metric used to describe the contagiousness or transmissibility of infectious agents, will help us further understand potential impact. The original coronavirus had a Rof 2.79, and the delta variant had a Rof 5.08. If the omicron variant’s Rexceeds this number (and is more virulent), we may find ourselves in a “bad” scenario. Experts have speculated that omicron is likely highly transmissible since it carries mutations found on the very contagious delta variant, as well as other mutations hypothesized to increase transmissibility. The variant’s apparently rapid rise in South Africa also suggests it spreads easily, although experts warn we don’t yet know for sure.

If omicron turns out to be the most transmissible variant yet, we should expect another wave of cases among the unvaccinated, likely accompanied by an increase in breakthrough infections. However, so long as our vaccines still are effective, most breakthrough infections will be mild, as was the case during the delta surge.

Even in this “bad” scenario, we’re still much better off than in past coronavirus waves. In just the last several weeks, we’ve seen the emergence of new, promising treatments—notably, oral antivirals that reduce the risk of hospitalization and severe illness. Pfizer’s antiviral, Paxlovid, was shown to provide an 89% risk reduction in outpatients. Merck’s antiviral, molnupiravir, was recently shown to reduce the risk of hospitalization and death from Covid-19 by 30%.

Because of the way these treatments work in the body, experts feel confident they’ll remain effective against the omicron variant. It’s possible that, at least at first, they could be reserved for unvaccinated people or high-risk groups or sent to areas with the greatest prevalence of the variant. It’s likely that FDA will discuss these possibilities as it reviews these drugs’ applications for emergency use authorization. It will also be essential that we can overcome some of the big obstacles for anti-viral treatments, such as access, rapid testing, and sufficient tracking.

Still, while post-exposure drugs will play an important role in a “bad” scenario, the key to preventing a truly “ugly” outcome will be vaccines. The World Health Organization and the Biden administration both echoed this message, recently urging people to get vaccinated and boosted to prevent further spread. Additionally, CDC just strengthened its booster recommendations, saying all eligible adults “should” get boosted (where previous guidance said they “may” get boosted) and Pfizer announced it is seeking approval of boosters for people ages 16 and 17.

The sooner vaccines are distributed throughout America and the world, the better the outcome will be—at least so long as the vaccines themselves remain effective.

The ‘ugly’ scenario: Vaccines falter, and omicron’s virulence is dangerously high.

The biggest question, then, is: What happens if our current vaccines falter?

Here’s where we want to be cautious. Most experts say omicron is extremely unlikely to fully evade existing vaccines. Scott Gottlieb, former FDA commissioner, recently said that “… if you talk to people in vaccine circles… they have a pretty good degree of confidence that a booster vaccine so three full doses of vaccine is going to be fairly protective against this new variant.” It would be irresponsible, and unhelpful, for us to speculate—in absence of any evidence, and against scientists’ best predictions—that vaccines could simply stop working.

But it’s possible that omicron will show a degree of immune escape.

If so, then many people who are vaccinated could fall ill. They in turn could pass the virus to others. And if omicron proves to be as virulent as or worse than past variants, many of those infected—especially those who are unvaccinated—will suffer and die.

This would render the next 100 days truly “ugly,” as manufacturers race to develop new vaccines and boosters against the new variant, and an already exhausted health care system copes with yet another devastating wave of cases.

In this scenario, health care leaders, policymakers, and public health officials will need to re-evaluate preventive strategies. We could once again see draconian measures such as lockdowns and sustained capacity mandates. However, President Biden recently announced that the U.S. will not resort to lockdowns or shutdowns as a result of omicron, making this possibility unlikely.

Even this scary scenario wouldn’t quite bring us back to March 2020. We know dramatically more than we did then about how to detect, contain, and treat Covid-19, and manufacturers stand ready to adapt their vaccines with all due haste.

But this scenario would be horrific, and the next few months would feel all too much like déjà vu.

Parting thoughts

When we’ve written these predictions about the pandemic in the past, we struggled to see how our individual actions could meaningfully inflect our trajectory toward a good, bad, or ugly outcome.

But whether one or none of these scenarios play out, it is important to step back and consider how we can rely on lessons we’ve learned over the past two years. Lessons such as encouraging vaccine uptake by going into the community, combatting structural inequities by acknowledging and acting, helping out vulnerable countries around the world, supporting the health care workforce, and much more.

If you are feeling overwhelmed after reading through these various scenarios, stuck in the treacherous mental waters of the unknown, you are not alone. It is okay to acknowledge the confusion of constantly emerging data as we learn how to proceed. But this is also true: these unknowns will not be the end of us. Somehow, amid the chaos of constant pandemic updates and new death tolls, we continue to move forward as a collective—doing our best to stay prepared, protected, and proactive.

And for us, that is a reason for hope.

Omicron: What we know (and still don’t) about the new variant

Michigan braces for omicron as COVID-19 hospitalizations climb

The new omicron variant is “more of a Frankenstein” than previous virus coronavirus variants, according to one virologist, and vaccine experts are at odds over how well current vaccines will provide protection against it.

A ‘Frankenstein’ variant

According to Alex Sigal, a virologist heading a team of researchers at the Africa Health Research Institute, the new variant is “probably the most mutated virus we’d ever seen.” However, Sigal added that he believes existing Covid-19 vaccines will continue to protect people against severe disease and hospitalization.

Similarly, Ugur Sahin, BioNTech co-founder, said that the Pfizer-BioNTech vaccine not only creates antibodies that prevent infection from occurring, but also creates T lymphocytes that attack cells after the body has been infected. Sahin argued that, even if omicron can evade antibodies, it would likely be vulnerable to T lymphocytes.

“Our message is: Don’t freak out, the plan remains the same: Speed up the administration of a third booster shot,” Sahin said.

Luke O’Neill, an immunologist and chair of biochemistry at Trinity College Dublin, said Sahin’s assumption makes sense from an immunological perspective. “There is optimism that the T-cells will hold the line—they are very good at stopping severe disease,” O’Neill said.

However, Stanley Plotkin, a scientist who has developed many vaccines, said Sahin’s assumptions were “gratuitous and without any proof.” Plotkin said so far there’s little evidence to suggest T-cells could fully protect against severe symptoms if a virus evades antibodies.

Further, Stéphane Bancel, CEO of Moderna, said, “There is no world, I think, where [the effectiveness] is the same level … we had with [the] Delta [variant] … I think it’s going to be a material drop. I just don’t know how much because we need to wait for the data. But all the scientists I’ve talked to … are like, ‘This is not going to be good.'”

However, former FDA commissioner Scott Gottlieb on Monday said, “There’s a reasonable degree of confidence in vaccine circles that [with] at least three doses … the patient is going to have fairly good protection against this variant.”

Angelique Coetzee, national chair of the South African Medical Association, said that so far, vaccinated patients who have tested positive for omicron “have no complication.” She noted that the nation’s hospitals were not overwhelmed by omicron patients, and most of those hospitalized were not fully vaccinated. Additionally, most patients she had seen did not lose their sense of taste and smell, and had only a slight cough, the New York Times reports.

“I have seen vaccinated people and not really very sick,” Coetzee said. “That might change going forward, as we say, this is early days. And this is maybe what makes us hopeful.”

Could omicron ‘outcompete’ delta?

Separately, Adrian Puren, acting executive director of South Africa’s National Institute for Communicable Diseases, said he believes omicron could become more pervasive than the delta variant. “We thought what will outcompete delta? That has always been the question, in terms of transmissibility at least … perhaps this particular variant is the variant,” Puren said.

William Schaffner, a professor of preventive medicine at Vanderbilt University School of Medicine, said that while nothing is certain yet, “it looks as though [omicron] will be as infectious as delta.”

As for how long it will take to answer questions about omicron, including its transmissibility and virulence, Tara Smith, an epidemiologist at Kent State University, said at minimum “it will take a month to get some preliminary data, and quite possibly longer to really know the fuller picture. We also won’t know about real-world experience in vaccine breakthroughs until that time.”

NIH director says it will take ‘weeks’ to understand omicron severity

https://thehill.com/homenews/sunday-talk-shows/583272-nih-director-says-it-will-take-two-three-weeks-to-better

NIH Director Francis Collins: “There's no reason to panic” over omicron yet.

National Institutes of Health (NIH) Director Francis Collins offered caution about the new omicron variant of the coronavirus in a Sunday interview, saying it will take weeks to understand whether it can evade COVID-19 vaccines.

Appearing on “Fox News Sunday,” Collins explained that omicron has more than 30 mutations on its spike protein, which raises the question of how effective the antibodies created by vaccines are against the variant.

“If you’ve raised antibodies against [COVID-19] from previously being infected or from being vaccinated, the question is, will those antibodies still stick to this version of the spike protein, or will they evade that protection? We need to find that out, to be honest, though that’s gonna take two, three weeks in both laboratory and field studies to figure out the answer. And that’s what all of us as scientists want to know,” said Collins.

Collins stressed that the COVID-19 vaccines available in the U.S. have been shown to be effective against previous variants, such as delta, saying that was a good indication they also will work against omicron.

“Given that history, we expect that most likely the current vaccines will be sufficient to provide protection. And especially the boosters will give that additional layer of protection because there’s something about the booster that causes your immune system to really expand its capacity against all kinds of different spike proteins, even ones it hasn’t seen before,” he said.

“Please, Americans, if you’re one of those folks who are sort of waiting to see, this would be a great time to sign up get your booster. Or if you haven’t been vaccinated already, get started. Omicron is one more reason to do this,” he added.

Britain authorizes Merck’s molnupiravir, the world’s first approval of oral covid-19 treatment pill

Regulators in Britain granted approval to the experimental drug molnupiravir from U.S. pharmaceutical giant Merck on Thursday, marking the first authorization from a public health body for an oral antiviral treatment for covid-19 in adults.

Experts have said that if widely authorized, the medicine could have huge potential to help fight the coronavirus pandemic: Pills are easier to take, manufacture and store, making them particularly useful in lower- to middle-income countries with weaker infrastructure and limited vaccine supplies.

“We will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,”Merck President Robert M. Davis said in a statement.

The company, which added that it would submit applications to other regulatory agencies, has applied to the U.S. Food and Drug Administration for emergency use authorization, while the European Medicines Agency has launched a rolling review of the drug.

“Today is a historic day for our country,” British Health Secretary Sajid Javid said in Thursday’s announcement. “This will be a game changer for the most vulnerable … who will soon be able to receive the ground-breaking treatment.”

In a global clinical trial, the pill reduced hospitalizations and deaths by nearly half among higher-risk adult coronavirus patients diagnosed with mild to moderate illness, according to Merck, which developed the drug with Ridgeback Biotherapeutics after it was discovered at Emory University. The first dose given to a volunteer in the trial was in the United Kingdom.

The U.K. medicines regulator approved the use of the treatment in people who are above 60 years old or have at least one other factor that puts them at risk of covid-19 developing into severe illness, such as obesity and heart disease. The agency found it “safe and effective” at curbing the risk after “a rigorous review.”

Britain became known during the pandemic for its speed in authorizing vaccines. It was the first country in the world to approve a coronavirus vaccine tested in a large clinical trial when it granted emergency-use authorization to the Pfizer-BioNTech shot last December.

The United States has made an advance purchase of 1.7 million courses of molnupiravir at a cost of about $1.2 billion, or roughly $700 per treatment course. Other countries have also reached agreements with Merck to buy the pills, including Australia, Singapore and South Korea.

The U.S. drugmakersaid it expects to produce 10 million courses of the treatment by the end of this year, along with at least 20 million in 2022, and that it plans to adopt a “tiered pricing approach” taking into account each country’s ability to pay.

The firm has also agreed to share its license for the pill with several Indian manufacturers and with a U.N.-backed nonprofit organization to allow production around the world and help boost access to more than 100 low- and middle-income countries.

The move stood out in a pandemic that has seen pharmaceutical companies lobbying to keep rights to vaccines. Some advocacy organizations, however, have criticized Merck for leaving out upper-middle-income countries hit hard by the pandemic.

Suerie Moon, co-director of the Global Health Center in Geneva, described the first approval of molnupiravir as “a big step forward.”

“I would say it’s very significant in terms of giving patients and the public a large confidence that this treatment can be widely used,” she said.

The drug — which received a type of conditional market authorization for products that fulfill an unmet medical need — will go by the name Lagevrio in Britain. It works by introducing errors that garble the genetic code of the virus and prevent it from making copies of itself. The window in which it can be administered and still work may be narrow, though, and the British regulator recommended taking it “as soon as possible” after a positive coronavirus test and within five days of symptoms onset.

The U.K. health secretary, Javid, called it “an excellent addition to our armory,” while urging people to keep getting their covid-19 shots. Doctors maintain the vaccines remain the principal tool against the coronavirus, as they seek to help prevent people from catching it rather than treating the disease after infection.

The pill is notably easy to use compared to monoclonal antibodies, a costly treatment that is infused or injected. Virologists have said they are hopeful that as well as limiting the risk of developing severe illness, the treatment could help reduce transmission of the virus too.

Breakthrough infections might not be a big transmission risk. Here’s the evidence

Conventional wisdom says that if you’re vaccinated and you get a breakthrough infection with the coronavirus, you can transmit that infection to someone else and make that person sick.

But new evidence suggests that even though that may happen on occasion, breakthrough infections might not represent the threat to others that scientists originally thought.

Ross Kedl, an immunologist at the University of Colorado School of Medicine, will point out to anyone who cares to listen that basic immunology suggests the virus of a vaccinated person who gets infected will be different from the virus of an infected unvaccinated person.

That’s because vaccinated people have already made antibodies to the coronavirus. Even if those antibodies don’t prevent infection, they still “should be coating that virus with antibody and therefore helping prevent excessive downstream transmission,” Kedl says. And a virus coated with antibodies won’t be as infectious as a virus not coated in antibodies.

Scant evidence for easy transmission of breakthrough infections

In Provincetown, Mass., this summer, a lot of vaccinated people got infected with the coronavirus, leading many to assume that this was an example of vaccinated people with breakthrough infections giving their infection to other vaccinated people.

Kedl isn’t convinced.

“In all these cases where you have these big breakthrough infections, there’s always unvaccinated people in the room,” he says.

In a recent study from Israel of breakthrough infections among health care workers, the researchers report that in “all 37 case patients for whom data were available regarding the source of infection, the suspected source was an unvaccinated person.”

It’s hard to prove that an infected vaccinated person actually was responsible for transmitting their infection to someone else.

“I have seen no one report actually trying to trace whether or not the people who were vaccinated who got infected are downstream — and certainly only could be downstream — of another vaccinated person,” Kedl says.

There’s new laboratory evidence supporting Kedl’s supposition. Initially, most vaccine experts predicted that mRNA vaccines like the ones made by Pfizer and Moderna that are injected into someone’s arm muscle would generate only the kinds of antibodies that circulate throughout the body.

But that might not be the whole story.

“I think what was the big surprise here is that the mRNA vaccines are going beyond that,” says Michal Caspi Tal, until recently an instructor at Stanford University’s Institute for Stem Cell Biology and Regenerative Medicine and now a visiting scientist at the Massachusetts Institute of Technology.

What Tal has found is that in addition to the circulating antibodies, there was a surprisingly large amount of antibodies in mucosal membranes in the nose and mouth, two of the primary entry points for the coronavirus.

The vaccinated aren’t “sitting ducks”

Immunologist Jennifer Gommerman of the University of Toronto found this as well.

“This is the first example where we can show that a local mucosal immune response is made, even though the person got the vaccine in an intramuscular delivery,” Gommerman says.

If there are antibodies in the mucosal membranes, they would likely be coating any virus that got into the nose or throat. So any virus that was exhaled by a sneeze or a cough would likely be less infectious.

Gommerman says that until now, it seemed likely that a vaccine that was delivered directly to the mucosal tissue was the only way to generate antibodies in the nose or throat.

“Obviously a mucosal vaccination would be great too. But at least we’re not sitting ducks,” Gommerman says. “Otherwise everyone would be getting breakthrough infection.”

Now, these studies by Gommerman and Tal have yet to undergo peer review, and some have already suggested that the antibodies they have described may not confer true mucosal immunity.

But there’s other evidence that a vaccinated person’s breakthrough infection may not transmit efficiently to others.

Marion Pepper, an immunologist at the University of Washington, says a recent study from the Netherlands looked at how well virus from vaccinated people could infect cells in the lab.

Pepper says the answer was not well.

“If you actually isolate virus from people who are getting a secondary infection after being vaccinated, that virus is less good at infecting cells,” Pepper says. “It’s not known why. Is it covered with an antibody? Maybe. Has it been hit by some other kind of immune mediators, cytokines, things like that? Maybe. Nobody really knows. But the virus does seem to be less viable coming from a vaccinated person.”

More studies are emerging that suggest there’s something different about the virus coming from a vaccinated person, something that may help prevent transmission.

Whatever it is, the University of Colorado’s Kedl says it’s one more reason that getting vaccinated is a good idea.

“Because you’re going to be even more protected yourself. And you’re going to be better off protecting other people.”

Kedl says that’s what you call a win-win situation.

How Merck’s antiviral pill could change the game for COVID-19

https://www.nationalgeographic.com/science/article/how-mercks-antiviral-pill-could-change-the-game-for-covid-19?cmpid=org=ngp::mc=crm-email::src=ngp::cmp=editorial::add=SpecialEdition_20211001::rid=C1D3D2601560EDF454552B245D039020

Coronavirus: 'Game-changing' oral pill molnupiravir reduces COVID-19  hospitalisations by half in trial | Newshub

A new drug by Merck significantly reduces the risk of hospitalization and death in people who take it early in the course of their COVID-19 illness, according to the interim results of a major study released today. It is the first oral antiviral found to be effective against this coronavirus.

People who took this drug, called molnupiravir—four pills twice a day for five days—within five days of showing symptoms were about half as likely to be hospitalized as those taking the placebo. They were also less likely to die, with eight deaths in the placebo group reported within a month of treatment and none in those who received the medicine.

“Having a pill that would be easy for people to take at home would be terrific. If this was available through a drug store, more people could get it,” says Albert Shaw, an infectious diseases specialist at Yale Medicine in New Haven, Connecticut, who was not involved with the research. All of the antiviral medicines available today, including remdesivir and the monoclonal antibodies, must be administered through an IV in a medical setting. Monoclonal antibodies are much more effective against COVID-19 and cut the risk of hospitalization and death by up to 85 percent, but this treatment costs almost three times as much as molnupiravir.

How the antiviral works

Antiviral drugs are used against many viruses, including for herpes and the flu. These drugs take advantage of the fact that viruses need to replicate inside a person’s cells in order to sicken them. Antivirals stop the replication process so the illness doesn’t progress.

The Merck drug works by introducing RNA-like building blocks into the virus’s genome as it multiplies, which creates numerous mutations, disrupts replication, and kills the virus.

Keeping the virus from multiplying is important because the more it replicates, destroying cell after cell, the sicker a person usually becomes, says Waleed Javaid, an epidemiologist and director of infection prevention and control at Mount Sinai Downtown in New York, who was not involved in the study. Additionally, when enough virus is inside the body the immune system may go into overdrive. “At a certain point the body detects a virus it has never seen and will throw everything against it, like a tank coming at a small target.” he says. This helps the body eliminate the virus but can cause sometimes deadly collateral damage throughout the body in its wake.

The research, which was conducted in numerous sites around the world, was stopped early because the results were so promising, Merck says. The drug was even effective against variants like Delta and Mu. Based on this interim analysis in 775 people, the company plans to submit an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration as well as regulatory bodies in other countries in hopes the drug can be made available. When that will happen is not clear, but the U.S. government has already agreed to purchase 1.7 million courses of treatment at $700 each, Merck notes.

Who can get the drug?

It’s also not known who would ultimately be authorized to take the medicine. The study included only people who were sick and unvaccinated and had at least one risk factor for developing a severe case of COVID-19, says Aaron Weinberg, national director of clinical research at Carbon Health, a for-profit provider of primary and urgent care, and a principal investigator of the study. This includes people who are older than 60, obese, immunocompromised from another condition, or have underlying heart or pulmonary disease, among others.

If the FDA does authorize the drug, it could limit who gets it to people like those in the research, Javaid says.

Although this drug looks promising, it’s a treatment but not a prophylactic like the vaccine. The medicine does not negate the need for unvaccinated people to get their shot, Shaw says. Some people taking the pills still got sick enough to be hospitalized. And while side effects in this study were mild—generally gastrointestinal issues, Weinberg says, and at comparable rates in the treatment and placebo groups—safety issues might emerge when the drug is given more broadly, Shaw says. Meanwhile, hundreds of millions of people have already gotten the vaccines with no major consequences.

Still, the results of this study should be celebrated, Javaid says. “Saving eight lives is huge, as is halving hospitalization,” he says. Perhaps another drug being studied will later prove to be more effective, reducing hospitalization by 80 or even 100 percent, he says. “But this is better than any oral antivirals we have right now, which is none,” he says.