Category: Covid-19 Vaccine

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U.S. study suggests vaccines may be ineffective against Omicron without booster - Reuters

The US Centers for Disease Control and Preventions vaccine advisers will meet on Thursday to revisit the benefits and risks for the Johnson & Johnson Covid-19 vaccine. The Advisory Committee on Immunization Practices is scheduled to vote on the vaccines recommendation for use.

According to an agenda posted online on Wednesday, the group will hear presentations about thrombosis and thrombocytopenia syndrome known as TTS a rare but serious type of blood clot that has been linked to the vaccine, as well as the benefits and risks assessment of the vaccine.

The CDC has said for months that the J&J vaccines known and potential benefits outweighed the known and potential risks. However, it says, women younger than 50 years old should be aware of the rare but increased risk of TTS, which involves blood clots with low platelets. Safety monitoring has been ongoing since the adverse event was first identified in April.

The advisory committee is scheduled to meet from noon to 4 p.m. ET Thursday. It is scheduled to vote at 2:30 p.m. ET. Its not clear what the voting question will be.

The single-dose Johnson & Johnson vaccine is authorized for use in people age 18 and older, and can be used as a booster shot for adults fully vaccinated with the J&J, Pfizer or Moderna vaccines.

The vaccine advisers will also hear a presentation on vaccine safety in children ages 5 to 11.

During a White House Covid-19 briefing on Wednesday, CDC Director Dr. Rochelle Walensky did not say why the committee was meeting about the Johnson & Johnson vaccine or whether she believes the benefits of the vaccine still outweigh the risks.

A source close to the situation told CNN the CDC has been "coy" about what the vote will be about, but it mayinvolvelimiting who's recommended to get the vaccine.

"I think a fair amount of the discussion will be about J&J do we need to use this one at all since we have so much of the others, or, if it's used, should it be focused on certain populations?" the source said. "J&J hasn't lived up to its billing as one and done."

"We could just take J&J off the table and do fine in this country," the source said.

The source added that its possible the CDC could recommend against the use of Johnson & Johnsons vaccine in women under age 50. While women 30-49 have seen the highest rates of the TTS blood clot, the source noted that it has also occurred in older women and in men.

J&J did not address the ACIP meeting in a response to CNN on Wednesday. It acknowledged that the US Food and Drug Administration updated its fact sheets for the vaccine on Tuesday to say people with a history of TTS should not get the Johnson & Johnson's Janssen Covid-19 vaccine.

Johnson & Johnson said "the safety and well-being of the people who use our products is our number one priority" and that it "strongly support raising awareness of the signs and symptoms of this rare event."

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Latest on the coronavirus pandemic and the Omicron variant - CNN

-- Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for NDA, to Japan's Ministry of Health, Labour and Welfare (MHLW)

-- Interim data from Phase 1/2 trial in Japan demonstrate robust immune response and favorable tolerability with no serious adverse events

GAITHERSBURG, Md., Dec. 16, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Company Limited (Takeda). Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M adjuvant, known as TAK-019 in Japan and NVX-CoV2373 outside Japan, is the first protein-based COVID-19 vaccine to be submitted under an NDA in Japan.

With the support of the MHLW, the companies are working to establish the capability to manufacture TAK-019 at Takeda's facilities in Japan and aim to begin distribution in early 2022, pending regulatory approval.

"Today's submission marks further progress in our quest to ensure broad global access to our protein-based COVID-19 vaccine," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Our partnership with Takeda reflects our shared commitment to tireless collaboration to deliver a COVID-19 vaccine, built on a well-understood vaccine platform."

The NDA submission includes an interim analysis from Takeda's ongoing Phase 1/2 immunogenicity and safety clinical trial of NVX-CoV2373/TAK-019 in Japan, in which the vaccine demonstrated a robust immune response and was well tolerated with no serious adverse events. Takeda submitted all available chemistry, manufacturing and controls (CMC), non-clinical and clinical data as of December 2021. Additional CMC data will be subsequently submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) during the NDA review period.

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The application also includes safety and efficacy data from Novavax' two pivotal Phase 3 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 circulating variants 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.

In addition to the submission of the NDA to MHLW in Japan, Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada, Singapore, United Arab Emirates, and the European Union and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea. Novavax expects to submit its complete CMC data package to the U.S. FDA by the end of the year.

About NVX-CoV2373NVX-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 AdjuvantNovavax' 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 NovavaxNovavax, 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, visit http://www.novavax.com and 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, the capability to manufacture TAK-019 at Takeda's facilities in Japan and aim to begin distribution in early 2022, Novavax' quest to ensure broad global access of its protein-based COVID-19 vaccine, Novavax' plans to deliver a COVID-19 vaccine to people around the globe, Novavax' plan to supplement the CMC data submitted to the PMDA with additional CMC data, and Novavax' plans to submit a complete CMC data package to the U.S. FDA by the end of the year 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 | 240-268-2022ir@novavax.com

Solebury TroutAlexandra Roy | 617-221-9197aroy@soleburytrout.com

MediaAlison Chartan | 240-720-7804Laura Keenan Lindsey | 202-709-7521media@novavax.com

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SOURCE Novavax, Inc.

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Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine - Yahoo Finance

As the first organization to envision a polio-free world through mass immunization of children, Rotary believes the decision to vaccinate is a humanitarian imperative. The Rotary International Board of Directors and Rotary Foundation Trustees believe that:

Global vaccination is the path to ending the pandemic, and we strongly encourage vaccination for all individuals, including our members.

Misinformation hinders the fight against COVID-19, and we are committed to providing our members with science-based information.

Rotary is engaged in assuring equity in vaccine access to all people. Through joint efforts with Gavi, the Vaccine Alliance we are leveraging our frontline experience with polio to facilitate vaccine delivery.

Rotary salutes health care workers everywhere as they continue to provide lifesaving services. We encourage clubs to offer recognition and encouragement to these heroes.

Rotary and Rotaract clubs are encouraged to redouble their efforts to support COVID-19 prevention and vaccination efforts.

As one of the greatest advances of modern medicine, vaccines are safe, effective and save millions of lives each year. They have eliminated or controlled numerous diseases such as polio, smallpox, measles, and Ebola, and now, there is the opportunity to end the COVID-19 pandemic through vaccination.

The eradication of polio remains the goal of the highest order for Rotary. We can continue to apply the lessons we have learned in fighting polio to COVID-19 response efforts.

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Rotary International and The Rotary Foundation release position statement on COVID-19 vaccination - World - ReliefWeb

Efficacy of the NVX-CoV2373 COVID-19 Vaccine Co-Administered With Seasonal Influenza Vaccines  Infectious Disease Advisor

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Efficacy of the NVX-CoV2373 COVID-19 Vaccine Co-Administered With Seasonal Influenza Vaccines - Infectious Disease Advisor

There's no need for variant-specific vaccines, they said, while hedging on the question of redefining what it means to be fully vaccinated, saying instead that Americans should get booster shots because it's the sensible thing to do.

And they noted that the Delta variant is wreaking plenty of havoc on its own. The US Centers for Disease Control and Prevention predicted an increase in the rate of deaths from Covid-19 over the coming weeks. It projected between 837,000 and 845,000 people will have died by January 8.

An average of close to 120,000 new Covid-19 cases are being diagnosed each day, according to data from Johns Hopkins University -- 50% more than a month ago. And more than 1,200 people are dying every day, on average.

"We are already in a Delta surge," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's Wolf Blitzer.

"The cases are going up. We have an average of about 117,000 cases. We have an increase in the percentage of hospitalizations. Deaths are still over a thousand," Fauci said. "Then you have, looking over your shoulder, the Omicron variant, which we know, from what's going on in South Africa and in the UK, is a highly transmissible virus.

"That's the reason why we are encouraging people, if they haven't been vaccinated, to get vaccinated but, as importantly, for those who've been fully vaccinated to get a booster."

There is no doubt Omicron will infect people who have been vaccinated, Fauci said.

'No doubt' about breakthrough infections

"There will be breakthrough infections, no doubt about that," he said.

Asked whether that means the federal government should redefine what it means to be fully vaccinated, Fauci said that does not really matter.

"Well, it's almost a semantic thing for the regulation, as it were," Fauci said. It just makes sense for people to get booster shots, he said.

"We know what optimal is. Optimal is getting a boost. So instead of worrying about what the definition of fully versus not fully is, I'm telling people, if you want to be optimally protected and you're vaccinated, get boosted. That's the message and not worry about a definition," he added.

For now, the federal government considers people to be fully vaccinated if they have received two doses of Moderna's or Pfizer's vaccine, or a single dose of the Johnson & Johnson vaccine -- even with the strong recommendations to add a dose to any of those regimens.

"The definition right now is two doses of an mRNA vaccine or a single dose of the J&J vaccine," US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky told a White House Covid-19 briefing.

More important is getting more people vaccinated, Fauci said.

"The vulnerable people are the people who have not been vaccinated, and I hope that the possibility that we're seeing -- that we're going to be getting a surge of Omicron, which is almost inevitable given its characteristic of high degree of transmissibility," Fauci said. "We have the tools to be able to blunt this. We just need to implement them."

Vaccine makers have said they are working ahead to ready formulations of their vaccines that would specifically protect against the Omicron variant. But Fauci said there's no need for them yet.

"At this point, there is no need for a variant-specific booster," Fauci told the White House briefing Wednesday morning.

Omicron 'freight train is here already'

It's probably too late, anyway, Dr. Peter Hotez, a vaccine specialist and dean of tropical medicine at the Baylor College of Medicine, told CNN's Alisyn Camerota and Victor Blackwell.

"It takes time to make that. They are talking maybe three or four months. This freight train is here already," he said. "It looks like it's going to be here around Christmas so that there's not going to be enough time to really have that booster in place to make a meaningful difference."

Americans are taking the advice to get booster doses to heart, with more than half of the nearly 1.8 million vaccines going into arms each day being booster shots, according to the CDC. Just over 61% of the population is now fully vaccinated and the pace of vaccinations is up 23% over a month ago.

"Across the first two weeks of December, we've gotten 14 million booster shots. That's our highest ever two-week total. So our booster program is accelerating," White House Covid-19 response coordinator Jeff Zients told the White House briefing.

"In looking at early data on transmissibility of Omicron from other countries, we expect to see the proportion of Omicron cases here in the United States continue to grow in the coming weeks," Walensky told the White House briefing. "Early data suggest that Omicron is more transmissible than Delta, with a doubling time of about two days."

But US health officials were keeping a wary eye on Britain, which reported its highest daily number of new coronavirus infections ever Wednesday -- 78,610.

Dr. Jenny Harries, Chief Executive of the UK Health Security Agency, said case numbers will be "quite staggering compared to the rate of growth that we've seen in cases of previous variants."

Omicron evades one Chinese vaccine

More studies indicated that current vaccines will not fully protect people against infection, and one worrying study from researchers in Hong Kong indicated that one of the most widely distributed vaccines, China's Sinovac Covid-19 vaccine doesn't provide sufficient antibodies to protect against the Omicron variant.

The researchers tested samples of Omicron variant virus in blood taken from 25 people who had received both doses of either Sinovac's Coronavac or Pfizer/BioNTech vaccines.

Blood taken from people who got the Pfizer/BioNTech vaccine also showed reduced immune response to the Omicron samples, with just 20% to 24% of samples producing sufficient neutralizing antibodies, the study by Kelvin Kai-Wang To and colleagues at the University of Hong Kong found.

CNN's Naomi Thomas, Jacqueline Howard, Deidre McPhillips and Allegra Goodwin contributed to this story.

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Omicron is coming but boosters should fight it, federal health officials say - CNN

Members of the public queue for Covid-19 vaccinations and booster jabs at St Thomas' Hospital on December 14, 2021 in London, England.

Dan Kitwood | Getty Images News | Getty Images

LONDON The U.K. is being engulfed by a tidal wave of Covid cases, with a growing number linked to the omicron Covid variant, as it races to give booster shots to as many people as possible.

Early studies show booster shots restore much of the vaccine protection lost through a natural waning of immunity and boost our bodies' ability to fight the omicron variant if we become infected.

This has prompted the U.K., U.S. and countries across Europe to throw everything they can at accelerating their booster shot programs, given the urgent need to protect citizens and prevent health services from being overwhelmed.

The U.K. in particular is being closely watched as it is already seeing what Prime Minister Boris Johnson warned would be a "tidal wave" of Covid cases, even though it's ahead of the U.S. and EU in terms of its booster shot deployment.

"The pace of [the booster] rollout across the four nations is such that the U.K. as a whole now has twice as many boosters per head as the EU and more than twice as many as the United States," U.K. Prime Minister Boris Johnson said Wednesday as he urged the public to get boosted as soon as possible.

"So let's keep going. Let's carry on giving omicron both barrels. Let's slow its spread and give the vaccines more time."

In the U.K., over 24 million people have now received a booster shot, according to official data that states 43% of the population aged 12 and above have received their third shot.

The data is likely to refer to adults, however; since Wednesday, anyone in England who is 18 or over can book a booster dose, as long as they had their second dose at least three months ago. Those aged 16 or over can also book it they have a health condition that puts them at high risk from Covid.

More than 650,000 booster shots were administered in the U.K. on Wednesday alone in a national effort that is involving the army, mobile vaccination centers, pharmacies and legions of volunteers to get shots into arms as quickly as possible.

It comes as omicron cases double every two days across the country, prompting a further surge in Covid cases. On Wednesday, the U.K. reported its highest ever daily number of Covid cases since the pandemic began, with 78,610 new infections. And another 88,376 cases were reported on Thursday.

In the U.S., the Centers for Disease Control and Prevention notes on its website that the current 7-day moving average of daily new cases (118,515) is 37.3% higher than the previous 7-day moving average (86,315).

However, CDC data shows that only 30% of U.S. adults over the age of 18 have received a booster shot (52.3% of the over-65s have received a third dose).

In the EU, meanwhile, data from the European Centre for Disease Prevention and Control shows that, as of Dec.15, just over 81 million third doses had been delivered, equating to around 18% of the total population of the EU and European Economic Area (the EU plus Iceland, Liechtenstein and Norway).

Germany and France have seen around 28.7% and 27.3% respectively of their adult populations take up the booster shot, despite rampant Covid cases in both countries. Germany reported more than 51,000 new infections on Wednesday and France reported 63,000 new cases.

Experts have judged omicron as being far more transmissible than the delta variant and believe it will soon become the dominant variant internationally.

It is too early to say whether it causes more severe illness as it was only designated as a "variant of concern" by the World Health Organization on Nov. 26.

The spread of the variant is also being aided and abetted by the winter in countries like the U.K., as there's more indoor mixing and social gatherings in the run-up to Christmas. British experts are warning people to try to limit their socializing if at all possible.

Dr. Jenny Harries, chief executive of the U.K. Health Security Agency, said on Wednesday that growth of the omicron variant over the coming days would be "staggering" given the current rate of infection. On Wednesday, the U.K. recorded 4,671 new cases of omicron, the UKHSA tweeted, taking the total omicron case number to 10,017 cases. On Tuesday, the total number of omicron cases had stood at 5,346.

One bright spot for the U.K. could be the relative ease it has in encouraging vaccine uptake, as long lines outside vaccination centers this week demonstrate. The U.K. was one of the first countries to start vaccinating people and around 81% of the population aged 12 or over has received two doses of a Covid vaccine.

It also has a lower rate of vaccine hesitancy compared to many other countries. An Ipsos survey conducted in conjunction with theWorld Economic Forumthis time last year when Covid vaccines were only just starting to be rolled out in Britain found that 77% of U.K. adults surveyed said they intended to receive a Covid vaccine, and hesitancy rates have fallen over the last year.

In comparison, 69% of those surveyed in the U.S. said they intended to get the vaccine and only 40% of adults asked in France intended to get the vaccine.

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UK to see 'staggering' omicron surge as it races to deploy boosters and the world is watching closely - CNBC

CARSON CITY, NV December 13, 2021

Tuesday, December 14 marks one year since the first doses of COVID-19 vaccine arrived in Nevada. From the first allocation of 17,550 doses of Pfizer vaccine through today, more than half of eligible Nevadans have received at least one dose of a COVID-19 vaccine.

I am continually grateful and thankful for Nevadas public health professionals who have continued to work nonstop throughout the COVID-19 pandemic to care for Nevadans. The COVID-19 vaccine roll-out continues to be a historic and monumental effort and that wouldnt be possible without the medical community and those working on the frontlines as vaccinators, said Nevada Governor Steve Sisolak. The work is tremendous but is nowhere near done we are continuing to use every tool at our disposal to reach Nevadans and make sure they have access to their first dose, second dose or a booster dose.

Nevadas COVID-19 vaccination response has required partnership among all levels of government, community organizations and individuals looking to protect themselves and their families from COVID-19.

This monumental task began for the Nevada State Immunization Program and Local Health Authorities before the first doses of vaccine were received in the state and has continued with each announcement of new vaccine presentations, expanded eligibility and booster doses.

Throughout the past year communities statewide, local governments, organizations and the State have developed plans and ideas to ensure the vaccine was available when and where it was needed. Some highlights from the year include:

Western States Scientific Safety Review Workgroup: In October 2020, before the vaccine was available to states, Nevada joined with California, Oregon, Washington and Colorado as the Western States Scientific Safety Review Workgroup to independently review the safety and efficacy of any vaccine approved by the Food and Drug Administration for distribution. Since the Workgroup formed, they have reviewed each decision issued by the FDA and Centers for Disease Control and Prevention to provide feedback and input to support safe and effective vaccination for residents.

Vaccine Playbook: The first version of the COVID-19 Vaccination Program Playbook was released in October 2020 in anticipation of the vaccine being sent to states, and the Playbook has been updated as changes have been made regarding eligibility and vaccine availability. Nevadas Playbook for Statewide Operations was a Nevada-specific plan crafted with input from each county, recognizing the states diverse geography, economy and populations. The document has been updated as the response has progressed to provide additional guidance and detail about priority populations and vaccine eligibility.

Vax Nevada Days: This effort was announced in June and led by Immunize Nevada with support from the Nevada Governors Office and Nevada State Immunization Program. Through the eight-week award period, 440,988 vaccines were administered to Nevadans, following a declining rate of vaccinations experienced in the month of June.The effort included eight weeks of prize drawings, with the announcement of a grand prize $1 million winner. Incentives included cash prizes ranging from $1,000 to $1 million and secondary education savings accounts for post-secondary education from $5,000 to $50,000. Additionally, more than 1,000 fishing licenses and nearly 500 Nevada State Park entrance permits were awarded to eligible residents. In total, 2,000 winners were randomly selected from all Nevadans who had received at least one dose of a COVID-19 vaccine, no matter when their vaccine process was initiated.

Get Out the Vaccine: In July, Nevada became the first state to partner with the Federal Emergency Management Agency (FEMA) surge teams offered by the federal government to assist the State in COVID-19 vaccination and outreach efforts. These teams targeted zip codes in Southern Nevada with low rates of vaccination and high rates of infection. Leveraging partnerships with community organizations, like Immunize Nevada and Mi Familia Vota, teams developed direct and targeted outreach in those zip codes. Teams canvassed 22 zip codes, supported more than 436 outreach and vaccination events and distributed almost 350,000 materials in the Las Vegas Valley.

Throughout Nevadas COVID-19 vaccination response, the goal has remained to ensure vaccine is available for all eligible Nevadans when and where they would like to be vaccinated.

COVID-19 vaccination and booster shots offer the best protection against COVID-19. State health officials remind Nevadans that everyone ages 5 years and older should get vaccinated with the COVID-19 vaccine approved for their age group.

Additionally, Nevadans ages 16 years and older are urged to get their booster dose when they are eligible (6 months after receiving their Pfizer or Moderna shots, or 2 months after receiving their Johnson & Johnson shot).

For more information on vaccination go to NVCOVIDFighter.org or call 800-401-0946.

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Nevada reflects on one-year anniversary of COVID-19 vaccination efforts - Nevada Governor

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Dec. 13 (UPI) -- Regions that require proof of COVID-19 vaccination to enter indoor restaurants, theaters and events see a boost in inoculation rates after instituting the policies, a study published Monday by the Lancet Public Health found.

Countries starting at lower-than-average vaccine coverage in the study, such as France, Israel, Italy and Switzerland, experienced a large increase in uptake of the shots after requiring so-called "vaccine passports" for certain activities, the data showed.

However, the requirements did not have a significant effect in Germany, where vaccine coverage already was high, or in Denmark, where vaccine supply was limited, the researchers said.

Increases in vaccination rates linked to these regulations was most pronounced in people 30 years old and younger.

When restrictions were applied to only nightclubs and large events in Switzerland, for example, the largest increase in vaccination rates were seen among people under age 20.

Based on the findings, COVID-19 proof-of-vaccination requirements could help increase inoculation rates in vaccine-complacent groups, such as younger people, the researchers said.

However, implementation should be considered in the context of existing circumstances, such as vaccination coverage, vaccine hesitancy, levels of trust in authorities and pandemic trajectory, they said.

"As mass vaccination programs continue to play a central role in protecting public health in this pandemic, increasing vaccine uptake is crucial both to protect the individuals immunized and break chains of infection in the community," study co-author Melinda Mills said in a press release.

"Overall, we observed a significant uptick in anticipation of restrictions coming into place around 20 days before introduction, which lasted up to 40 days after," said Mills, director of the Leverhulme Center for Demographic Science at the University of Oxford in England.

COVID-19 certification, or "vaccine passports," require people to have proof of their being fully vaccinated, having tested negatively for the virus or having recovered following infection to access public venues and events.

Despite objections from people who consider the policies an infringement on civil liberties, several cities across the country have instituted them, including Los Angeles, New York City and San Francisco.

For residents of these cities, proof of vaccination is required to enter and dine at restaurants, attend concerts and sporting events, or see a movie in a theater.

In addition to helping prevent the spread of COVID-19 in public areas, some studies suggest that requiring proof-of-vaccination might encourage more unvaccinated people get the shot, particularly those who perceive their own risk from the virus as low.

For this study, Mills and her colleagues assessed vaccination rates before and after the institution of vaccine passports in six countries that introduced them between April and September 2021.

The countries included in the analysis were Denmark, Israel, Italy, France, Germany and Switzerland.

Modelling was used to estimate what vaccination rates would have been in each of these countries without vaccine passports.

The models were based on vaccination trends from 19 otherwise similar control countries without similar proof-of-vaccination requirements.

In countries in which vaccine coverage previously was low, introduction of COVID-19 vaccine passports was associated with a significant increase in the number of additional vaccine doses per million people.

Israel experienced a 24% boost in vaccine doses administered after implementation of the requirements, while France saw a 13% increase and Italy and Switzerland each had a 7% rise, the data showed.

Compared with the 19 control countries, daily COVID-19 case numbers decreased after proof-of-vaccination implementation in France, Germany, Italy and Switzerland, but increased in Israel and Denmark.

"We know that certain groups have lower vaccine uptake than others, and it may be that COVID-19 certification is a useful way to encourage vaccine complacent groups, like young people and men, to get vaccinated," study co-author Tobias Rttenauer said in a press release.

"However, COVID-19 certification alone is not a silver bullet for improving vaccine uptake and must be used alongside other policies, such as targeted vaccine drives," said Rttenauer, a post-doctoral research fellow at the University of Oxford.

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Study: Requiring proof of COVID-19 vaccination for some activities boosts shot uptake - UPI News

Scientists have worked at an unprecedented speed to develop coronavirus disease 2019 (COVID-19) vaccines to contain the ongoing pandemic caused by the rapid spread of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). To date, several COVID-19 vaccines have received emergency use authorization (EUA) from global regulatory bodies, and vaccination programs have commenced in the majority of the countries of the world.

Vaccines offer prophylactic immunization against specific diseases by triggering a persistent, adaptive immune response that generates immunological memory, protecting against future infections. Typically, T cells offer adaptive immune protection, and the humoral antibody response is mediated by B cells. After vaccination, the B cells get activated and produce neutralizing antibodies that can bind to target proteins of a virus and, subsequently, protect the individual from the disease. The cell-mediated immune response is associated with the activation of the effector CD4 T cells, which stimulate B cells to produce antibodies. These cells may also employ other cells, such as macrophages, which possess microbicidal functions. Activated CD8 T cells eliminate virus-infected cells. Both CD4 and CD8 memory T cells persist long after vaccination and are primed to become effector T cells. Previous studies have shown that natural killer cells also possess memory-like behavior.

Through vaccines, pathogenic protein subunits are introduced in an individual that stimulates the B and T cells responses. Some of the common forms of vaccines are inactivated viruses, vectors that infect cells to generate viral proteins, messenger RNA (mRNA), and viral proteins. mRNA COVID-19 vaccines are likely to induce both CD4 and CD8 T cells responses.

In the current scenario, it is extremely important to measure the effectiveness of the vaccines as well as vaccination strategies. Typically, the response to vaccines is evaluated by detecting and measuring antibodies against viral proteins present in the serum. Vaccine response can also be evaluated by detecting activated B and/or T cells.

One of the shortcomings of antibody-based assays (e.g., ELISA) is that they cannot detect low levels of antibodies, which might be sufficient in protecting from a particular disease. In many instances, the levels of antibodies decrease significantly long after vaccination or natural infection, but they offer strong protection against the disease. Detectable levels of antibodies may develop, for antibody-based assays, at least a few weeks post-vaccination.

ELISpot is a technique that is used to detect T and B cells that are responsive to the vaccine. This assay can measure interferon-gamma or granzyme B from the activated cells. Although this method can indirectly assess the activity of immune cells, it is not always accurate.

A new study published on the bioRxiv* preprint server has hypothesized that T cell receptors (TCR) repertoire can measure the response to vaccines, as it would identify the TCR of clones that respond to the vaccination.

Previous studies have revealed that TCR is a heterodimer of two trans-membrane polypeptide chains (TCR and TCR) linked by covalent disulfide bonds and a complete TCR repertoire can reflect the T cells present in an individual.

Researchers have developed a novel and accurate method known as Tseek, which is unbiased and provides sensitive profiling of TCR and TCR chains or TCR repertoire by sequencing the TCR a and b chains. To evaluate the effectiveness of Tseek in the assessment of vaccine responses, researchers compared the responses to mRNA COVID-19 vaccines and the annual influenza vaccines. Based on epidemiological and antibody data, the vaccines have very different rates of efficacy, i.e., the effectiveness of the COVID-19 vaccine is 90%, whereas the influenza vaccine is 30%.

Scientists have evaluated the different outcomes of the vaccines using the Tseek method. In this context, they utilized PBMC samples from individuals who consistently received yearly influenza vaccines over several flu seasons for several years. Additionally, researchers collected PBMC samples from individuals who received two doses of COVID-19 mRNA vaccines were obtained. Neutralizing antibody titers were also measured in COVID-19 vaccine samples.

This study revealed that an individuals TCR signature evolves gradually over the years in response to infections. Scientists found that SARS-CoV-2 vaccination induced a broad-spectrum T cell response that involved many expanded clones; however, this was not the case for the influenza vaccine, which elicited a narrower response involving fewer clones. In addition, many T cell clones provided temporal details that are typically not obtained from antibody measurements, especially, before the antibodies are detectable.

The current study revealed that TCR repertoire is a valuable biomarker for studying immune reactions to the vaccine. The authors highlighted some of the advantages of using Tseek to determine the response to vaccines, including it being a non-invasive approach, rapid assessment of vaccine efficacy, i.e., within a few days of vaccination, and a highly sensitive and specific method. The current study truly demonstrates that TCR repertoire sequencing can be effectively used for early and sensitive measurement of the adaptive immune response to vaccination, which can help improve the selection of the immunogen and optimize vaccine strategy.

bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

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Determination of the effectiveness of COVID-19 vaccination using T cell receptor repertoire - News-Medical.Net