Category: Covid-19 Vaccine

GAITHERSBURG, Md., Dec. 13, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a regulatory filing to the Ministry of Health and Prevention (MoHaP) for emergency use of its COVID-19 vaccine in the United Arab Emirates (UAE).

"The rapid emergence and continuedspread of variants is a stark reminder that no one is safe until everyone is safe in the fight against COVID-19," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We remain committed to delivering our vaccine, which is based on a proven, well understood platform, to countries around the world as we anticipate that ongoing vaccination will be necessary over the long term to end the pandemic."

Novavax made the submission for the regulatory evaluation by MoHaP of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The filing includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulatingvariants of concern and variants of interest, and 90.4% efficacy overall; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.

Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine inIndonesiaand thePhilippines, and the companies have filed for EUA inIndiaand for Emergency Use Listing (EUL) with theWorld Health Organization(WHO). Novavax also announced regulatory filings for its vaccine in theUnited Kingdom,Australia,New Zealand,Canada, theEuropean Union, Singapore and with theWHO.Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA)submission to MFDSinSouth Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

The chemistry, manufacturing and controls (CMC) data package submitted to MoHaP and other global regulatory agencies leverages Novavax' manufacturing partnership with SII, the world's largest vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulatingvariants of concern and variants of interest, and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels.

About Matrix-M Adjuvant

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, received Emergency Use Authorization in Indonesia and the Philippines and has been submitted for regulatory authorization in multiple markets globally. NanoFlu, the company's quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company's NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visitwww.novavax.comand connect with us on Twitter,LinkedIn, Instagram and Facebook.

Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, the scope, timing and outcome of future regulatory filings and actions, Novavax' plans to submit a complete package to the U.S. FDA by the end of the year, and Novavax' plan to supplement the CMC data submitted to the MoHaP with data from the additional manufacturing sites in Novavax' global supply chain are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

InvestorsNovavax, Inc.Erika Schultz| 240-268-2022[emailprotected]

Solebury TroutAlexandra Roy| 617-221-9197[emailprotected]

MediaAlison Chartan| 240-720-7804Laura KeenanLindsey | 202-709-7521[emailprotected]

SOURCE Novavax, Inc.

http://www.novavax.com

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Novavax Files for Emergency Use of COVID-19 Vaccine in the United Arab Emirates - PRNewswire

At least 90% of adults in Maryland have received one dose of their COVID-19 vaccine, according to the Office of Gov. Larry Hogan.

At least 90% of adults in Maryland have received at least one dose of their COVID-19 vaccine, according to the Office of Gov. Larry Hogan.

Hogan celebrated the milestone in a Saturday news release, saying that Even as we continue to urge booster shots, we are also very focused on getting the remaining unvaccinated individuals vaccinated.

As part of our commitment to leave no arm behind, we will work to get that last remaining 10% vaccinated. This continues to be the single most important thing you can do to protect yourself, your family, and your fellow Marylanders, Hogan continued.

The state identifies adults as everyone who is 18 or older who received their first shot.

Booster shots are also on the rise in Maryland with 60% of the states eligible seniors having received one. On Thursday, Hogan expanded eligibility for boosters to include anyone 16 and older.

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Looking for more information? D.C., Maryland and Virginia are each releasing more data every day. Visit their official sites here: Virginia | Maryland | D.C.

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90% of Maryland adults have received at least one dose of a COVID-19 vaccine - WTOP

COVID-19 ushered in the biggest vaccination campaign in history. And a relentless disinformation campaign about vaccines quickly followed.

One of the latest controversial statements about the vaccines came from Robert F. Kennedy Jr., a nephew of former President John F. Kennedy, and one of the biggest sources of anti-vaccine rhetoric today, as he spoke to Louisiana lawmakers.

Kennedy was given the floor for about 20 minutes during a Dec. 6 Louisiana House oversight meeting on a proposal that would require students to get vaccinated against COVID-19 before entering school. The meeting ended several hours later with the state House Committee on Health & Welfare voting 13-2 to oppose requiring vaccination.

Kennedy used his time to make a series of problematic and false statements about the COVID-19 vaccines and, at one point, argued that the shots record "confirms that this is the deadliest vaccine ever made."

Pointing to a pie graph that compiled deaths reported in the federal governments Vaccine Adverse Event Reporting System over the last 30 years, Kennedy claimed that there are "more people who have died in eight months from this vaccine than from 72 vaccines over the last 30 years."

But there are several errors with Kennedys claim. We address them here, one by one.

VAERS is unreliable

The biggest issue is the low-quality data that Kennedy relies on to make his point.

VAERS, which is run by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration, was established in the late 1980s to help health agencies and researchers collect and analyze data on vaccine after-effects and to detect patterns that may warrant a closer look. But the database is an open-access system and unlike other government data sources that are screened before being made available to the public.

VAERS is designed so that anyone parents, patients and health care professionals can freely report any health effects that occur after a vaccination, according to the CDC, whether or not those effects are believed to be caused by a vaccine.

The reports arent verified before theyre entered and have included car accidents and incidents of self injury. Still, anyone with a computer can search the data, download it, and interpret the numbers as they wish making VAERS fertile ground for vaccine misinformation.

The VAERS search engine has a prominent disclaimer that says: "The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines." VAERS reports alone "cannot be used to determine if a vaccine caused or contributed to an adverse event or illness," it says. People using the database are required to click on a form saying that they understand these limitations.

Dr. Paul Offit, director of the Vaccine Education Center and physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia, said VAERS is misnamed because it leads people to believe that if something was reported, its automatically an adverse effect of the vaccine.

"At its best, VAERS is a hypothesis-generating mechanism. It really should be titled suspected adverse event," Offit said. "There is no screening. You could report that your child got the vaccine and turned into the Incredible Hulk."

More than 459 million doses of COVID-19 vaccines have been administered in the United States from Dec. 14, 2020, through Nov. 29, 2021, according to the CDC. During this time, VAERS received 10,128 reports of death (0.0022%) among people who received a COVID-19 vaccine, agency spokesperson Martha Sharan told PolitiFact in an email. That includes people who died of any cause.

"Reports of adverse events, including deaths, do not necessarily mean that a COVID-19 vaccine caused a health problem," Sharan added. "Statements that imply that reports of deaths to VAERS following vaccination equate to deaths caused by vaccination are scientifically inaccurate, misleading and irresponsible."

Health officials have data on billions of individuals who have received multiple doses of the COVID-19 vaccines, said Dr. Rebecca Weintraub, an assistant professor in the Department of Global Health and Social Medicine at Harvard Medical School.

"So yes, we are confident that we have a robust database that these vaccines are as safe and effective as other vaccines," Weintraub said. "It prevents death, it prevents severe disease and it decreases transmission. And we know that for those who are vaccinated who get breakthrough cases, they clear the virus faster."

On average, 2,800 people die each day in the U.S., and health officials say that there will always be people who got a vaccine who die afterward from unrelated causes. This is especially true for a vaccine that over 70% of the countrys population has received.

"Hank Aaron is one example," Offit said. "He died of a stroke because he was in his mid-80s, not because of a vaccine."

The CDC said in an email to PolitiFact that it hasnt detected any unusual or unexpected patterns for deaths following immunization that would indicate that the COVID-19 vaccines are causing or contributing to deaths, outside of six confirmed deaths following the Johnson & Johnson vaccine due to complications from a rare and serious adverse reaction called thrombocytopenia syndrome. The reaction prompted officials to pause injections of the vaccine for about 10 days.

In an email, Kennedys spokesperson, Rita Shreffler, cited the same VAERS numbers and said that a 2010 study found that, as opposed to overcounting, VAERS vastly undercounts vaccine injuries fewer than 1%.

But that study evaluated an automated system that tracked a patients health changes following a vaccination, rather than the voluntary reporting system that Kennedy drew his numbers from. It also didnt explain how it calculated the percentage.

In VAERS, the degree of underreporting varies widely depending on the symptom being reported, the Department of Health and Human Services said on its website.

"As an example, a great many of the millions of vaccinations administered each year by injection cause soreness, but relatively few of these episodes lead to a VAERS report," HHS says. "Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes."

COVID-19 vaccines comparewith other vaccines

Ren Najera, an epidemiologist and editor of the College of Physicians of Philadelphias History of Vaccines website, said that Kennedys statement is typical of anti-vaccine activists who make inflammatory comments without credible evidence.

Najera said that its difficult to compare the COVID-19 vaccines with vaccines from decades ago because the technology and communication are better. If anything, he said, a very small signal of an adverse reaction would be identified and detected more quickly now than back then.

"First, we had the smallpox vaccine in the early 1800s," Najera said. "It was given to millions around the world, but we just don't know how many people may have died from it there was no such thing as a clean needle back then. But we do know that it prevented smallpox, and the epidemic started to die down afterward."

The closest thing to a "deadly" vaccine was the result of a lab accident, Najera said, not the therapeutic itself.

When the polio vaccine was licensed in the 1950s, independent labs started to create it. One California lab, Cutter Laboratories, didnt deactivate the virus used in the vaccine as it should have, and several thousand children were exposed to the live polio virus, with several dozen dying as a result.

When the flu vaccine rolled out in the mid-to-late 1970s, it was found that on very rare occasions, people developed Guillain-Barr syndrome after being vaccinated. Guillain-Barr is a disorder in which the immune system attacks the nerves, and it can also result from the flu itself. In the late 1990s, the live virus RotaShield vaccine was found to be a rare cause of intussusception, a type of bowel blockage caused when the intestine folds into itself like a telescope. There was one death, and the vaccine was pulled from the market.

"This was caught by the same surveillance systems we have now, and while it was very treatable it was still taken off the market," Najera said.

Offit said vaccines have in rare cases been associated with adverse events, including the diseases theyre meant to prevent, but that Kennedys claim is "just not true."

"The COVID-19 shots are very typical of vaccines, which have associated adverse events," he said. "The mRNA COVID-19 vaccines are a rare cause of myocarditis. The J&J vaccine is a very rare cause of one in 500,000 for blood clots.

"The flu vaccine can rarely cause Guillain-Barr syndrome. The polio vaccine that we used from the early 60s to 2000s was a rare cause of polio. The yellow fever vaccine can cause yellow fever for about one per million recipients."

Meanwhile, few measures in public health can compare with the impact of vaccines, which medical officials and analysts say have saved more lives than any other single medical advance. Vaccinations have reduced disease, disability, and death from a variety of infectious diseases by protecting those vaccinated and by reducing the spread of disease. One 2017 report highlighted the impact in the U.S. of immunization against nine diseases, including smallpox, measles and polio. All were shown to have been reduced by 90% or more.

Our ruling

Kennedy claimed that the COVID-19 vaccine is the deadliest vaccine ever made according to deaths reported in VAERS.

VAERS is an unreliable source, and the agencies that run it say its reports cannot be used on their own to establish whether a vaccine caused any adverse event.

Health officials and experts said that the COVID-19 vaccines are safe and comparable to others, and that they would have been discontinued if they had caused many deaths.

We rate this Pants on Fire!

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No, the COVID-19 vaccine is not the deadliest vaccine ever made - PolitiFact

Saturday marks one year since the Food and Drug Administration authorized Pfizer's COVID-19 vaccine the first of three COVID-19 vaccines now in use in the United States.

During that time, more than 480 million shots have been administered, and just over 60% of eligible Americans are fully vaccinated. But even with those protections, case numbers have gone up 22% in the past two weeks.

Confirmed COVID cases showed up this week at an average rate of 120,000 per day, according to the U.S. Centers for Disease Control and Prevention. Ninety-nine percent of those new cases are from Delta variant, not Omicron.

The hope is that current vaccines will also be effective in beating back the Omicron variant.

But government officials are still preparing for the worst.

In New York, Governor Kathy Hochul issued a statewide indoor mask mandate on Friday. Anyone entering a New York business that does not have a vaccination policy is required to wear a mask.

Hochul said now is the time to take action to stop the spread of the Omicron COVID variant.

"We're entering a time of uncertainty and we could either plateau here or our cases could escalate beyond control," said Hochul.

More Omicron variant cases surfaced this week, with at least 75 known cases in 25 states. The CDC analyzed 43 of those cases and found nearly 80% of the people afflicted are fully vaccinated.

Additionally, CDC Director Dr. Rochelle Walensky said there was a pattern in the cases studied.

"Over half were between the ages of 18 and 39 and about one-third reported international travel before they were diagnosed," she said.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to the president, continues to urge people to get vaccinated and get booster shots to protect against the virus.

New cases increased some 37% since last week pushing case numbers up in 44 states.

Case numbers continue to compromise health care delivery in some places, according to St. Joseph County deputy health officer Dr. Mark Fox.

"Not just the ability to treat COVID patients, but the ability to treat everything else," he said. "There are surgeries being delayed for cancer, for a heart valve, for everything you can think of, and a number of patients who are boarding in the emergency room waiting for beds, so the system is really stressed right now," said Fox.

A survey of 250 hospitals from across the country shows that unvaccinated COVID patients are eight times more likely to require hospitalization than vaccinated people.

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One year after FDA authorized Pfizer's COVID vaccine, cases are on the rise - CBS News

For many Americans who scrambled to get vaccinated against COVID-19 as soon as their turn came up, the relief of gaining immunity was just one reward. Achieving fully vaccinated status conferred a faint halo of virtue as well.

Now, both the shots biological protection and the satisfaction of contributing to the herds immunity are proving short-lived. And with a worrisome new coronavirus variant threatening to erode vaccine-induced immunity further, health officials are debating whether the definition of fully vaccinated should be amended to include a booster shot.

Scientists are leaning heavily in favor, and public health leaders are not far behind.

So far, the Centers for Disease Control and Prevention hasnt officially shifted the goalposts. Americans subject to job-related vaccine mandates or required to show proof of full vaccination to enter gyms, restaurants or public events can satisfy the requirement without a booster.

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But the CDC has tiptoed up to those goalposts, telling all but the youngest vaccinated Americans that durable immunity will require an extra dose, and urging everyone 16 and older to get one as soon as they are eligible.

Dr. Anthony Fauci, President Bidens senior advisor on the pandemic, also walked right up to the line but didnt cross it.

Optimal protection is going to be with a third shot, Fauci told CNN this week. He added that while he didnt see the official definition of fully vaccinated changing this week or next, it was bound to happen at some point: Its going to be a matter of when, not if.

The number of fully vaccinated Americans, under the current definition, passed the 200 million mark this week, and a quarter of them have gotten a booster. That leaves millions of Americans with another to-do item on their list, asking whether theyll be better off if they get one, and wondering whether it will be the last.

Their confusion is understandable. The vaccines early promise of spectacular effectiveness has given way to some gloomy headlines about waning immunity. But the CDC has continued to assert that for most healthy Americans, full vaccination two jabs of the Pfizer-BioNTech or Moderna vaccine or a single Johnson & Johnson shot provides powerful protection against hospitalization or death in those with breakthrough infections.

Until recently, independent vaccine experts seemed ambivalent too. In September and October, advisors to the CDC and the Food and Drug Administration who reviewed the latest evidence were distinctly underwhelmed by the case made for recommending boosters for healthy adults under 65.

They endorsed the extra shots wholeheartedly for older Americans and people with compromised immune systems. But many were unwilling to conclude that younger adults would benefit from a booster, especially considering the risk of heart-related side effects that mostly affect younger men and blood clotting risks for women under 50.

Their vote to limit access was promptly overruled by the CDC, which recommended boosters for virtually all adults once six months had passed since their second dose of one of the two mRNA vaccines or two months had passed since their J&J shot.

Now, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical School, experts who had doubts are abandoning their qualms.

For starters, he said, sending different messages to different age and occupation groups had proved too confusing. Plus, new research has made it increasingly clear that the first two doses of an mRNA vaccine and the single shot of the J&J vaccine, behave like a single prime dose that requires a follow-up boost to reach its full effect.

As with most vaccines, a COVID-19 booster will be required to shore up immunity and make it last. And theres precedent for a three-dose series, he noted. Widely administered vaccines for hepatitis B, polio and other diseases require three or more shots.

Dr. Peter Hotez, dean of Baylor Universitys National School of Tropical Medicine, agreed: From the beginning, Ive said this is a three-dose vaccine.

Given the sense of urgency that prevailed when vaccines first became available, it made sense to space the first and second doses of mRNA vaccine close together, Hotez said. But based on previous experience with vaccines, we know thats going to result in waning immunity. And youll need a third dose some time later.

By summer, the rising incidence of breakthrough infections offered growing support for that surmise. Most of the initial cases were in older and immunocompromised people, who frequently dont mount a strong immune response to vaccines. Many experts hoped the need for boosters would end there.

But evidence of waning immunity from all vaccines, and across the age spectrum, is growing. Even fully vaccinated younger adults with breakthrough infections can become severely ill and die.

This week brought the first real-world evidence of boosters benefits in young, healthy people. Israeli researchers found that a third dose of the Pfizer vaccine prevented infections more dramatically in 16- to 29-year-olds than in any other age group measured. Given the key role of young adults in sustaining pandemic spread, some scientists suggested a policy of universal boosters could do more than reduce hospitalizations and deaths. It might also suppress new waves of infections.

That and another new study from Israel also shored up evidence of boosters powerful benefit for middle-age adults. Israelis 50 and over who got a third shot were 10 times less likely to die of COVID-19 than their vaccinated-but-unboosted peers. Israelis 60 and over reduced their risk of severe illness by a factor of more than 12 compared with their counterparts who didnt get a third shot, and they were almost 15 times less likely to die of COVID-19.

Los Angeles County has provided further evidence of boosters impact. For the seven-day period that ended Nov. 29, there were 43 new infections for every 100,000 residents who were fully vaccinated but not boosted. But among those who did get a booster, the rate of new infections was just 7 per 100,000.

For now, Hotez said, communicating clearly to those 16 and up that they should get booster shots for their own protection is more important than changing the definition of fully vaccinated something that would affect everyday life in cities like Los Angeles and San Francisco that require proof of vaccination to enter indoor businesses like restaurants and gyms.

As health officials grapple with the pandemics next move, he said, they may decide that reducing COVID-19 deaths and keeping people out of the hospital are the most urgent priorities. That would dictate a greater focus on increasing rates of initial vaccinations over boosters.

But if case rates begin to recede, emphasizing boosters might be a way to slow transmission and end the pandemic sooner and changing the definition of fully vaccinated may well support such a goal, Hotez said.

Some experts remain skeptical that taking that step would make sense. They ask whether it is ethical and productive to offer extra doses to those least likely to become very ill when many of the worlds poorest countries have barely begun vaccinating their populations.

The new findings from Israel clearly show that booster shots are valuable to people 50 and older, said Dr. Emily P. Hyle, an infectious disease specialist at Massachusetts General Hospital. But it gets a little trickier to conclude that theyre useful for younger people, she added.

Im looking for more granular data on what type of symptoms theyre preventing. Is it a day of sniffles or a week or two of significant illness? Hyle said. Thatll be really helpful to know.

The answer could inform a fuller debate on whether getting more Americans or the rest of the world their initial doses of vaccine is a more effective use of scarce resources, she said. That, in turn, should also spark some tough conversations about the goals U.S. health officials should shoot for: to stamp out transmissions altogether, minimize severe illness and deaths, or return to pre-pandemic life without public health strictures.

Hotez said its possible a fourth shot or more will be needed. That will depend on a host of unknowns beyond the human immune systems response to boosters, including the emergence of variants that erode vaccine protection, and the priorities of health leaders.

We dont know till we know, he said.

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Should the definition of 'fully vaccinated' include a booster shot? - Los Angeles Times

Anthony Fauci isnt convinced Covid-19 vaccine manufacturers are going to need to produce an Omicron-specific version of their vaccines.

Rather, the long-time director of the National Institutes of Allergy and Infectious Diseases suggested to STAT in an interview Thursday, its possible the current vaccines will provide enough protection against the new variant for most vaccinated and boosted individuals.

Fauci stressed that he was hypothesizing, based on how the vaccines have held up against other SARS-CoV-2 variants. Studies will need to be done, he insisted. And manufacturers are working on and will test versions of their vaccines based on the mutation-studded Omicron spike protein. Thats prudent, he said.

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The companies are going to be making variant specific boosters, Fauci told STAT. But what I think is something that we need to keep our eye on [is] it could be that things turn out better than we expected.

Omicron was first identified in late November in Botswana and South Africa, and was declared a variant of concern by the World Health Organization on Nov. 26. On Wednesday, WHO Director-General Tedros Adhanom Ghebreyesus said the variant has been found to be circulating in 57 countries. That number includes the United States. In parts of Europe, the variant appears to be picking up steam.

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The many differences between this version of the virus and others that pre-date it most especially the original strain that emerged from Wuhan, China, in early 2020 have led to speculation about whether the target of the existing Covid vaccines should be updated to focus on Omicron.

But on Wednesday, Pfizer and BioNTech released data suggesting that while two doses of their vaccine might not be enough to stave off Omicron viruses, people who had received a booster dose may have adequate protection. And in an interview with STAT, Kathrin Jansen, Pfizers head of vaccine research, said she hasnt yet developed a gut feeling about whether the vaccine will need to be updated.

You know, now we get ready. We look at the evidence. I think we are in a position to address it. But I do not have a good sense right now if we want to, need to, should have to. You have to give us a little bit more time, Jansen said.

Faucis views are similar. He noted that many studies have shown that the vaccines can protect against a range of variants that have emerged.

Im not so sure that were going to have to get a variant-specific boost vaccine to get an adequate protection from Omicron, he said. Because if you look at protection against variants, it appears to relate to the level of immunity and the breadth of the immunity that any given vaccine can instill on you.

Weve seen also when you boost yet again with the ancestral strain, vaccines that target the Wuhan virus not with a variant-specific strain, you get a rather dramatic multi-, multi-fold increase [in antibodies] what I would call a projection or a prediction of protection, Fauci said.

He pointed to a study from South Africa released earlier this week. It reported that, when blood from people who had been vaccinated was exposed to the Omicron virus, there was a substantial reduction in neutralization as compared to the vaccine strain. (The study, which has not yet been peer-reviewed, did not include people who had been given booster doses.)

But the neutralizing capacity of blood drawn from people who had been vaccinated after having had a Covid infection told a different story. When you looked at people who were vaccinated and infected, they did pretty well. And to me, vaccinated and infected is equivalent to getting boosted, Fauci said.

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Fauci: Omicron-specific version of Covid vaccines may not be necessary - STAT

A study conducted by the Social Policy Institute at Washington University in St. Louis shows that among surveyed parents in Israel, only 37 percent intended to vaccinate their child (aged 5-11) against COVID-19 when the option became available, while 23 percent of parents were undecided and 40 percent had no intention to vaccinate their children.

The study was conducted November 3-8, 2021, among a representative sample of Israeli parents of children aged 5-11 (N = 912).

Unlike COVID-19 vaccination among adults, where the uptake rate varies among population groups, intention to vaccinate children varies much less, from 34 percent among ultra-Orthodox (Haredi) and traditional Jews to 40 percent among secular Jews. (Figure 1).

Child age, however, appears to make a difference in parents decision on vaccination. As childrens age increases, parents are more likely to intend to vaccinate them. Accordingly, intention to vaccinate children rises from 30 percent for children aged 5 up to 46 percent for 11-year-old children. Child gender on the other hand, does not matter (Figure 1).

The findings also suggest that parents who oppose child vaccinations against COVID-19 do not oppose vaccinations on principle. Even among parents who are vaccinated themselves against COVID-19, the majority are either still undecided or not intending to vaccinate their children against COVID-19, as only 42 percent of parents claim that they intend to vaccinate their children. Furthermore, previous vaccination of a child is also not an indicator of intention to vaccinate them against COVID-19; only 40 percent of parents who gave their children all their infant and toddler vaccinations on time intend to give them the COVID-19 vaccine as well (Figure 1).

That is, it seems that resistance to vaccinate children against COVID-19 does not exclusively stem from parent fear of child vaccinations, nor from deterrence from COVID-19 vaccines in general. Instead, the circumstance that deters parents is the combination of the two: COVID-19 vaccines in children. The aforementioned unwillingness to vaccinate younger children illustrates that the fear of COVID-19 vaccines for children is related to their young age.

In a previous study we found that the perception of lack of transparency about vaccines from the government deterred Israeli adults from getting vaccinated. Out of a desire to encourage childrens vaccination and because of the previous experience with adult vaccines, the Israeli Ministry of Health decided to increase transparency by opening one of its discussions on COVID-19 child vaccination to the public on November 4, 2021.

Our study finds that indeed this measure positively influenced parents to vaccinate their children. Nevertheless, it seems that one instance of transparency is not enough to achieve a significant effect, indicating that more effort in this direction is needed. Our findings suggest a modest impact, as 37 percent of undecided parents report that this measure encouraged them to vaccinate their children, compared to only 7 percent of parents who do not intend to vaccinate them.

According to our study, transparency is a focal issue for parents, as approximately half of them feel that it lacks in many aspects: 45 percent of parents feel there is not enough transparency on vaccine side effects, 59 percent of them feel the states agreement with Pfizer lacked transparency, and 55 percent feel that there is not enough transparency in the governments decisionmaking process (Figure 2).

These perceptions made the difference in parents willingness to vaccinate their children: Parents who felt theres enough transparency were approximately three times more likely to intend to vaccinate their children compared to those who felt that there is not enough transparency (Figure 2). Furthermore, parents claim that once they feel that theres full transparency, they will vaccinate their children at higher rates. Among those who do not intend to vaccinate, 50 percent report that pro-transparency measures will encourage them to vaccinate their children, and, among undecided parents, up to 90 percent claim that they would be encouraged by these measures.

It seems that the Israeli governments decision to open its discussion to the public was a move in the right direction. Scaling up the increased transparency through open governmental meetings has the potential to double vaccination takeup among children.

Since Israel was one of the first countries in the world to vaccinate its population, its pandemic experience has become a test case for the other countries to learn from. Israeli vaccination rate declines created by vaccine hesitancy have been early warning signals to other countries that having a sufficient supply of COVID-19 vaccines is just the first barrier to vaccine uptake.

Although child vaccination against COVID-19 started in Israel very recently (on November 22, 2021) and a few weeks after the U.S., uptake rates in the U.S. and Israel are quite similar, as two-thirds of American parents of children aged 5 to 11 are either reluctant or adamantly opposed to childrens vaccination against COVID-19. That is, the need for the authorities to increase the proportion of vaccinated children is common to both countries. Moreover, the publics wish for more transparency, and the significant effect better transparency can have on COVID-19 vaccine uptake, is also common to more nations including the U.S.

In conclusion, the Israeli experience brings unequivocal findings that can be used by governments around the globe, suggesting that efforts to improve transparency and convey information to the public are an effective policy measure that encourages COVID-19 vaccinations. Our findings also show that while this is true for vaccinations of adults and adolescents, it is twice as true for vaccinations of children whose parents protectiveness increases hesitation. Increasing transparency is the most effective way to address vaccine hesitation among parents.

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What we can learn from Israels COVID-19 vaccination of children - Brookings Institution

The first real-world study of how vaccines hold up against the Omicron variant showed a significant drop in protection against symptomatic cases caused by the new and fast-spreading form of the coronavirus.

Government scientists on Friday also offered the most complete look yet at how quickly Omicron was spreading in Englands highly vaccinated population, warning that the variant could overtake Delta by mid-December and, without any precautionary measures, cause Covid-19 cases to soar.

Those warnings were reinforced by a computer modeling study of England released on Saturday suggesting that even in populations with high levels of immunity, Omicron could significantly disrupt life and overwhelm hospitals. Scientists cautioned that those projections could change as they learned more about the severity of Omicron infections.

The vaccine study published Friday indicated reduced levels of protection. Four months after people received a second dose of the Pfizer-BioNTech vaccine, the shots were roughly 35 percent effective in preventing symptomatic infections caused by Omicron, a significant drop-off from their performance against the Delta variant, the scientists found.

A third dose of the Pfizer-BioNTech vaccine, though, lifted the figure to roughly 75 percent.

Two doses of the AstraZeneca vaccine appeared to offer virtually no protection against symptomatic infection caused by Omicron several months after vaccination. But for those recipients, an additional Pfizer-BioNTech dose paid big dividends, boosting effectiveness against the variant to 71 percent.

Still, the studys authors said they expected that the vaccines would remain a bulwark against hospitalizations and deaths, if not infections, caused by Omicron. And the researchers cautioned that even in a country tracking the variant as closely as Britain is, it was too early to know precisely how well the vaccines would perform.

That study was released alongside new findings about how easily Omicron is managing to spread. Someone infected with the Omicron variant, for example, is roughly three times as likely as a person infected by the Delta variant to pass the virus to other members of his or her household, Britains Health Security Agency reported.

And a close contact of an Omicron case is roughly twice as likely as a close contact of someone infected with Delta to catch the virus.

Neil Ferguson, an epidemiologist at Imperial College London, said that Omicrons ability to evade the bodys immune defenses accounted for most of its advantage over previous variants. But modeling work by his research team also suggested that Omicron was simply more contagious than Delta, by roughly 25 to 50 percent.

I think that theres a significant amount of immune escape, Dr. Ferguson said, referring to the viruss ability to dodge the bodys defenses. But its also more intrinsically transmissible than Delta.

He and other scientists have cautioned that evidence was still coming in, and that better surveillance in places where the Omicron wave is most advanced could affect their findings.

The World Health Organization said this week that some evidence had emerged that Omicron was causing milder illness than Delta, but that it was too early to be certain. Still, scientists have warned that if the variant keeps spreading as quickly as it is in England, where cases are doubling every 2.5 days, health systems around the world may be deluged with patients.

Even if Omicron causes severe illness at only half the rate of the Delta variant, Dr. Ferguson said, his computer modeling suggested that 5,000 people could be admitted to hospitals daily in Britain at the peak of its Omicron wave a figure higher than any seen at any other point in the pandemic.

Scientists said that widespread vaccination in countries like Britain and the United States would keep as many people from dying as have in earlier waves. But the experts also warned that patients with Covid and with other illnesses would suffer if hospitals became too full.

It only requires a small drop in protection against severe disease for those very large numbers of infections to translate into levels of hospitalization we cant cope with, Dr. Ferguson said.

It will take several weeks to understand how the current surge in Omicron infections may translate into people needing hospital care. Im concerned that by the time we know about severity, Dr. Ferguson said, it may be too late to act.

The potential for a surge in hospitalizations was thrown into sharp relief by the modeling study released on Saturday, created by a separate group of experts at the London School of Hygiene & Tropical Medicine. For now, those scientists assumed that Omicron would cause disease just as severe as Delta does in unvaccinated people, but also that mounting levels of immunity from vaccinations and previous infections would temper the Omicron wave, as has happened in South Africa.

In the scenario that some outside experts said was most likely in which Omicron evaded peoples immune defenses to a large degree, but booster doses also proved highly effective the scientists said that England could be hit hard. Through April, they predicted roughly 300,000 hospitalizations and 47,000 deaths.

That could place a bigger daily burden on English hospitals at the peak of the Omicron wave than was seen at any time earlier in the pandemic.

Crucially, the scientists said that reintroducing certain restrictions could save thousands of lives and spare tens of thousands of people hospital stays.

Outside experts emphasized that Omicron remained poorly understood, that people may be able to fight off severe infections more effectively than the models predicted, and that the arrival of new antiviral pills in the coming months could soften the blow of infections.

Still, scientists urged governments to speed up inoculation campaigns, share doses with less-vaccinated nations and consider measures like more self-testing, if not new restrictions.

The coronavirus has not finished with us, said Michael Head, a senior research fellow in global health at the University of Southampton in England.

A tactic of turning the lights off and pretending we are not in is a failed policy.

Excerpt from:

Covid-19 Live Updates: Omicron Cases, Vaccines and Boosters News - The New York Times

NAIROBI, Dec 10 (Reuters) - Now that rich nations are sharing more COVID-19 shots with Africa, health officials across the continent are scrambling to overcome vaccine hesitancy and logistical problems to get the doses into arms fast enough before they expire.

Penda Health, a Nairobi-based chain providing low-cost private healthcare, has found a way to speed things up: bring the shots closer to people's homes.

For many Kenyans, travelling to one of the big hospitals prioritised as vaccine centres meant lost earnings from taking time off work and finding transport they could ill afford. So many didn't go.

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But this week, dozens of people patiently queued up for a shot outside Penda's Tassia Medical Centre, a clinic now delivering the vaccine on their doorstep in one of Nairobi's poorer neighbourhoods.

"It's closer to my place. I have a son so it's more accessible. I just walk a minute and I'm here," said Nancy Mwebi, 26, adding that many of her friends had feared they would be charged for the doses once they reached a big hospital.

The small Tassia Medical Centre administered 442 jabs last week, compared to the 782 shots given over the same period at Karen Hospital, one of Nairobi's largest private hospitals.

With just 7% of people fully vaccinated across Africa and supplies of vaccines improving, experts are urging African governments to copy the kind of approach taken by Penda to improve take up across the continent.

When Penda noticed many of its patients were unable to access vaccines after doses began arriving in Kenya in March, it approached the health ministry to set up a partnership.

But Penda, founded in 2012, still only offers shots in seven of its 21 clinics in Nairobi because of the expense involved in rolling out the programme.

The shots may be free but Penda has to pay 240,000 Kenyan shillings ($2,100) for World Health Organization-approved refrigerators to store them and has staffing costs to administer the vaccine and keep records that amount to $1,000 a month for each clinic.

"It's a small price to pay to get this many shots in arms, but on the other hand, it is very challenging for the narrow margins we have at our medical centres," said Penda's chief medical officer Dr. Robert Korom.

Last week, Penda administered about three in every 1,000 COVID vaccines given in Kenya, data from Penda and the ministry of health showed.

"The ministry of health is aware that vaccination needs to get to the last mile and especially in villages and grassroots," Andrew Mulwa, the ministry's acting director of medical services, told Reuters.

He said partners, including private sector players, were critical to achieve Kenya's target of vaccinating the entire adult population by the end of 2022.

($1 = 112.8 Kenyan shillings)

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Reporting by Maggie Fick; Editing by Katharine Houreld and Edmund Blair

Our Standards: The Thomson Reuters Trust Principles.

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Coming to a clinic near you: Kenya's COVID-19 vaccine drive gets a boost - Reuters

Some establishments already require proof of vaccination before entry. Now, there will a new way to provide that information in Connecticut: a digital health ID.

The technology is similar to vaccine passports used in other states. Governor Ned Lamont announced Friday that it will be in Connecticut by the end of the year.

The governor said this is a new tool available to local businesses, but using it will not be a mandate.

"What I want to do is get that digital health card, make it available to every single business, restaurant, store, let them make the right decision in terms of allowing people into their facility," Lamont said.

The governor is expecting to see interest from retailers and restaurants that were hit hard during lockdown.

At Music & Arts in West Hartford, sales representative Pete Borzellino does not know yet whether the store will make use of the technology, but thinks it will provide convenience.

Its just going to be a little bit easier to track," Borzellino said. "It is easy to lose things, I lost my card not too long ago.

His customer, Frank Bonavento, agrees.

It sounds like ease of access more than anything," Bonavento said.

Lamont's announcement comes as New York Governor Kathy Hochul announced Friday that all public places that do not require proof of full vaccination must require masks come Monday.

However, Lamont said he does not plan to implement new statewide mandates.

"You voluntarily get the digital health card and stores voluntarily use it as they see fit," he said.

Nonetheless, the co-owner of Powerhouse Super Gym in Berlin has concerns, saying the gym took a big financial hit during lockdown. Jack Banks worries this could lead to regulations.

Even though its starting as something thats voluntary, many things have started as voluntary and they all the sudden become mandated. And I fear the slippery slope," Banks said.

Eric Gjede with the Connecticut Business and Industry Association sees this as a way for people to feel more comfortable shopping local during the holiday season.

We really do not want to see any more restrictions placed on businesses," Gjede said. "But businesses can choose whether or not they want to use it, and they're going to be able to provide a little bit of extra peace of mind to other patrons.

Lamont said the digital vaccine verification system could be rolled out on a regional basis in partnership with Massachusetts and Rhode Island.

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Digital Health ID For COVID-19 Vaccination Status Coming to Connecticut - NBC Connecticut