POST 154. April 19, 2021. CORONAVIRUS. “Breakthrough infections, which occur when fully vaccinated people are infected by the pathogen that their shots were designed to protect against, are an entirely expected part of any vaccination process.” “Pfizer’s chief executive said that a third dose of the company’s Covid-19 vaccine was “likely” to be needed within a year of the initial two-dose inoculation — followed by annual vaccinations.”

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“White House chief advisor Dr. Anthony Fauci said people may need to get booster shots for the Covid vaccines in a year, during an interview with MSNBC’s Medhi Hasan Monday.

Recent data suggests that Pfizer and Moderna’s Covid vaccines provide protection for at least six months, Fauci said…

“We know for sure it’s effective for six months and highly likely that it will be effective for considerably longer period of time,” Fauci said.

The Pfizer study only measured to the six-month mark, and more research needs to be done to determine when or how vaccine protection wanes.

“The way to get the answer is to just follow people closely enough to determine when that level of efficacy or protection diminishes, both with regard to the level of the antibodies as well as clinical data with regard to breakthrough infections,” Fauci said. (Breakthrough cases refer to when people who are vaccinated get infected.)

Ultimately, “if it turns out [to last] a year or a year and a half, we very well may need to get booster shots to keep up the level of protection,” Fauci said.

Protection could end up lasting two to three years, but the point is that boosters are still on the table as a possibility, he told Politico on April 5.”  (A)

“The Centers for Disease Control and Prevention has documented approximately 5,800 breakthrough coronavirus cases in individuals who have been vaccinated.

“All of the available vaccines have been proven effective at preventing severe illness, hospitalizations, and deaths,” the agency said in an emailed statement. “However, like is seen with other vaccines, we expect thousands of vaccine breakthrough cases will occur even though the vaccine is working as expected.”

The number of breakthrough incidents reported to the CDC represents far less than 1% of the Americans who have been fully vaccinated, which is over 76 million.

“Vaccine breakthrough infections make up a small percentage of people who are fully vaccinated,” the agency said. “CDC recommends that all eligible people get a COVID-19 vaccine as soon as one is available to them.”  (B)

“The CDC told The Hill on Thursday that about 7 percent of the recorded breakthrough cases resulted in hospitalization and about 1 percent of the people who contracted breakthrough infections died.

The breakthrough COVID-19 infections reported to the CDC were out of more than 75 million fully vaccinated individuals in the U.S., occurring in less than 0.008 percent of fully vaccinated people. Hospitalizations have occurred in 0.0005 percent of all full vaccinations and deaths in almost 0.0001 percent.

“To date, no unexpected patterns have been identified in case demographics or vaccine characteristics,” the CDC said…

The CDC said COVID-19 breakthrough cases were reported among “all people of all ages eligible for vaccination.”…

“CDC is monitoring reported cases for clustering by patient demographics, geographic location, time since vaccination, vaccine type or lot number, and SARS-CoV-2 lineage,” the agency said.” (C)

“One study found that just four out of 8,121 fully vaccinated employees at the University of Texas Southwestern Medical Center in Dallas became infected. The other found that only seven out of 14,990 workers at UC San Diego Health and the David Geffen School of Medicine at the University of California, Los Angeles tested positive two or more weeks after receiving a second dose of either the Pfizer-BioNTech or Moderna vaccines. Both reports, published on Tuesday in the New England Journal of Medicine, show how well the vaccines work in the real world, and during a period of intense transmission.

But these breakthrough cases, though quite rare, are a sharp reminder that vaccinated people are not invincible, especially when the virus continues to circulate widely.

“We felt really strongly that this data should not lead people to say, ‘Let’s all get vaccinated and then we can all stop wearing masks,’” said Dr. Francesca J. Torriani, an infectious disease specialist at UC San Diego Health who led the California study. “These measures have to continue until a larger segment of the population is vaccinated.”” (D)

“In public health, a “breakthrough case” is when a fully vaccinated person later gets the disease they were vaccinated for. No vaccine provides 100 percent protection against infection, so breakthrough cases are not new, and not unique, to COVID-19. There have been reports of COVID-19 breakthrough cases in South Carolina and throughout the U.S., and this is not unexpected.

COVID-19 vaccines are very effective in preventing mild symptoms, severe disease, and hospitalizations due to COVID-19 disease. But it is still possible for a fully vaccinated person to get infected if they are exposed to the virus. These individuals may have no symptoms or mild symptoms, yet they can still spread the virus to others. That’s why even after getting vaccinated for COVID-19 we recommend continuing to wear a mask, keep your distance, avoid crowded settings, and wash your hands: this helps you to prevent exposure to the virus and unknowingly spreading it to others.

Because fully vaccinated people usually have some immunity against the disease, breakthrough cases usually have either no symptoms or mild symptoms.  A breakthrough case occurs when an individual has had a lower immune response from the vaccine. No vaccine is 100 percent effective.”(E)

“”CDC has developed a national COVID-19 vaccine breakthrough database where state health department investigators can currently enter, store, and manage data for cases in their jurisdiction,” the CDC said.

“Vaccine breakthrough infections make up a small percentage of people who are fully vaccinated. CDC recommends that all eligible people get a COVID-19 vaccine as soon as one is available to them. CDC also continues to recommend people who have been fully vaccinated should keep taking precautions in public places, like wearing a mask, staying at least six feet apart from others, avoiding crowds and poorly ventilated spaces, and washing their hands often.”

Outside experts agreed.

The likelihood of these “very rare” infections depends on how much virus is circulating within a community, Dr. Kawsar Talaat, an infectious disease physician and assistant professor at Johns Hopkins Bloomberg School of Public Health, told CNN.

“That’s the whole point of getting to herd immunity,” Talaat said. “Because once we get to a point where enough people in the community are vaccinated, then if somebody develops Covid in that community, the people around them are protected and it’s much harder for that person to spread the virus to somebody else, and therefore the transmission stops.”

Less transmission means fewer breakthrough cases, said Dr. Carlos del Rio, executive associate dean at Emory University School of Medicine.

“There is currently a lot of transmission in many parts of the country. Vaccines will help decrease that,” del Rio said. “Get vaccinated as soon as you can and help control this pandemic.”” (F)

“This incomplete protection that some people experience occurs to some extent with a vaccine against any disease, says Dr. Saad Omer, a vaccine researcher at Yale University, and the numbers gathered so far are in line with what’s expected, the CDC says.

The three vaccines authorized for use against COVID-19 in the United States appear to be at least 94% effective at preventing severe disease and death (starting about two weeks after a person is fully vaccinated), according to data reported so far, and about 80% effective at preventing infection. But that’s not 100%, Omer notes, so a relatively small number of infections despite immunization with these very effective vaccines is to be expected…

Meanwhile, scientists are trying to figure out why breakthrough infections occur.

“Right now we don’t have a great understanding of exactly where we’re open — our sort of Achilles’ heel,” says Dr. Alexander Greninger, an infectious disease researcher at the University of Washington.

Is the determining factor how much virus someone is exposed to? Or maybe exposure to one of the variants that can evade the immune system?

“Is it people in the lower part of the vaccine response mixing with the variants? I think it’s a little bit more — honestly — mysterious,” Greninger says.

Solving that mystery could help scientists improve the vaccines to prevent more breakthrough infections. Booster shots might become part of the answer down the road, they say.

The CDC is continuing to monitor breakthrough coronavirus infections “for clustering by patient demographics, geographic location, time since vaccination and vaccine type or lot number.” In addition, the agency is studying specimens of virus from people who experience breakthrough infections, including conducting genetic studies to see if any particular variants are more likely to be involved than others.” (G)

“Some of the breakthrough infections are thought to stem from certain strains of the virus that may be more resistant to vaccines, experts say. They also say some highly contagious variants may pose a greater risk of reinfection from other variants, but much of the research around that has been lab-based and lacks real-world context.

In New York City, health officials are trying to extrapolate more real-world data as it relates to its most dominant variants, including the B.1.526 strain that is thought to have originated in Washington Heights last year before spreading to other boroughs and states. Right now, the city is still investigating whether that variant poses a higher risk of reinfection from other variants or causes more severe outcomes, according to a detailed report from health officials earlier this week.

Reinfection remains highly rare, though New York City hasn’t publicly reported data on any potential cases of that it may be investigating locally…

Overall, health officials admit the presence of variants is likely highly underreported. The CDC, along with individual states and cities, only conducts the exhaustive genetic sequencing to detect variants in about 5 percent of samples, which is up from 2 percent a number of months ago. It’s still a fraction of all positive cases.” (H)

“In some ways, the shots’ staggering success in trials—where breakthrough cases were also observed, causing appropriately minimal stir—may have papered over the inevitability of post-vaccination infections in more natural settings. “The vaccines exceeded expectations,” Luciana Borio, a former acting chief scientist at the FDA, told me. Now, as we exit what Borio calls the “honeymoon phase” of our relationship with the jabs, we need to temper our enthusiasm with the right amount of realism, especially as more data on the shots’ strength and longevity accumulate. Even excellent vaccines aren’t foolproof, and they shouldn’t be criticized when they’re not. “We can’t expect it’s going to be perfect, on day one, always,” Borio said…

Efficacy, a figure specific to clinical trials, also doesn’t always translate perfectly to the messiness of the real world, where there’s immense variability in how, when, where, by whom, and to whom shots are administered. The vaccine’s performance under these conditions is tracked by a separate measure, called effectiveness. Studies rigorously examining vaccine effectiveness are challenging, but early data suggest that the Pfizer-BioNTech and Moderna shots are living up to their initial hype…

There’s something a touch counterintuitive about breakthrough cases: The more people we vaccinate, the more such cases there will be, in absolute numbers. But the rate at which they appear will also decline, as rising levels of population immunity cut the conduits that the virus needs to travel. People with lackluster responses to vaccines—as well as those who can’t get their jabs—will receive protection from the many millions in whom the shots did work. In a crowd of people holding umbrellas, even those who are empty-handed will stay more dry.” (I)

“To Topol, there was nothing surprising about a case like mine. He and his colleagues had been looking at some seventy cases of breakthrough infections in San Diego. On March 23rd, The New England Journal of Medicine published a letter to the editor from a group of researchers in Southern California who had found that the risk of infection in fully vaccinated health-care workers there was higher than in the original vaccine trials, but still extremely low—around one per cent. Breakthrough infections have been reported in Florida, Michigan, and Washington. Much of the time, these cases are caught through routine testing of health-care workers, and the infections are asymptomatic. Symptomatic cases like mine are more unusual….

“People with breakthrough infections really need to be studied,” Topol said. “The highest priority is to sequence the virus of the breakthrough infections.” Currently, labs in New York City are sequencing a fraction of the virus samples, every week. These samples are then cross-referenced with patient databases to see whether the person has been vaccinated against or was previously diagnosed with covid-19. Statistics on breakthrough infections, and on the role of variants in these infections, come from this process. The problem, however, is that vaccinated people are unlikely to shed enough virus to sequence; this means that breakthrough infections may be passing under the radar.” (J)

“However, according to the Washington Post, there are some challenges in collecting accurate information about breakthrough cases. For instance, people who’ve been vaccinated may be less likely to get tested if they get symptoms of Covid-19, writing off a stuffy nose or cough to a cold rather than Covid-19. And even some of the post-vaccination fatalities are still under investigation to determine if they were caused by Covid-19 or something else…

According to the Post, there’s no clear-cut explanation as to why some people remain susceptible to the virus after vaccination. However, Fauci on Friday hypothesized that some people, such as the elderly and those with underlying health conditions, may have a weak immune response to the vaccine—an issue that has more to do with the characteristics of an individual patient than the overall efficacy of a given vaccine. “I don’t think that there needs to be any concern about any shift or change in the efficacy of the vaccine.”

According to the Post, while none of the currently authorized vaccines are 100% effective at preventing infection, research last year indicated that the Pfizer-BioNTech and Moderna vaccines had nearly 100% efficacy at preventing hospitalization. In addition, studies suggest that in real-world conditions, the vaccines are about 80% effective at reducing the odds of infection after the first shot, and about 90% effective after the second dose.

And although conducted at a different time, when more variants had emerged, research on Johnson & Johnson’s vaccine—whose use federal officials are currently pausing—presented 100% efficacy rate against hospitalization and death, as well as a 85% efficacy rate against severe illness, Becker’s Hospital Review reports.

Moreover, research indicates that the protection afforded by these vaccines could last for a substantial amount of time, with at least one study finding that fully vaccinated individuals had high antibody levels more than six months after being inoculated. Emerging research suggests the vaccines may also limit how infectious vaccinated people are if they do contract the virus, the Post reports.” (K)

“Scientists have long said that giving people a single course of a Covid-19 vaccine might not be sufficient in the long term, and that booster shots and even annual vaccinations might prove necessary.

In recent days, that proposition has begun to sound less hypothetical.

Vaccine makers are getting a jump-start on possible new rounds of shots, although they sound more certain of the need for boosters than independent scientists have.

Pfizer’s chief executive Albert Bourla said on Thursday that a third dose of the company’s Covid-19 vaccine was “likely” to be needed within a year of the initial two-dose inoculation — followed by annual vaccinations.

Dr. David Kessler, who runs the Biden administration’s vaccine effort, told a House subcommittee on Thursday that the government was also looking ahead. One factor at play is the spread of coronavirus variants and whether further vaccination could better target mutant strains.

Mr. Bourla said that “a likely scenario” is “a third dose somewhere between six and 12 months, and from there it would be an annual re-vaccination.” Moderna said this week that it was at work on a booster for its vaccine, and Johnson & Johnson has said that its single-shot vaccine will probably need to be given annually.

Dr. Kessler emphasized the “strong efficacy” of the current vaccines, including against the variants, but said that the government was “taking steps to develop next generation of vaccines that are directed against these variants if in fact they can be more effective.”…  (L)

“In the first four months that COVID-19 vaccines have been available — between Dec. 14 and April 13 — more than 75 million people in the U.S. were fully vaccinated against the virus. Of those who were fully vaccinated, just under 6,000 later became infected with COVID-19.

Those statistics mean that the “breakthrough rate” of COVID-19 infections in fully vaccinated people in the U.S. is a measly 0.008%.

The CDC further reports that only about 400 of those who suffered a breakthrough infection were sent to the hospital, and 130 of those who were hospitalized were “asymptomatic or hospitalized for a reason not related to COVID-19.”

A total of 74 people have died after suffering a COVID-19 breakthrough infection — meaning less than one out of every 1 million people who were vaccinated later died after contracting COVID-19. Of those deaths, nine were “reported as asymptomatic or the patient died due to a cause not related to COVID-19.”

The CDC study is consistent with the findings published by drug companies during their trials last year — that the vaccines are safe and highly effective.”  (M)

“Noting that there’s “nothing surprising” about the breakthrough rate, Francis Collins, director of the National Institutes of Health, added, “These are still vaccines that are fantastically safe and effective. But 95% [efficacy] is not 100%.”

He voiced concern that people opposed to the vaccines will use breakthrough cases to claim the vaccines don’t work—an argument he pushed back on. “Would you stop wearing your seat belt because you heard somebody who was wearing a seat belt got run over by an 18-wheeler and didn’t survive?” he asked.” “ (K)

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