Category: Vaccine

By Tracy Neal, Open Justice reporter of

The nation's newly branded health agency has been ordered to remove, or fix misleading advertisements about Covid-19 vaccination. (File image) Photo:

The nation's newly branded health authority has been ordered to remove or fix a misleading advertisement about vaccination against Covid-19 that ran across multiple media platforms.

The Advertising Standards Authority complaints board received 44 complaints against Te Whatu Ora/Health New Zealand's Vaccinate for Life advertisements which ran across television, print and on billboards and mobile phones.

In a statement to Open Justice, the health agency's National Immunisation Programme has apologised for any confusion or concern caused by the advertisements, which concluded in July.

Programme director Astrid Koornneef said while it was disappointed with the decision, it accepted the authority's ruling, which related to one element of a wider vaccination campaign.

The complaints said the advertisement, in its various forms, was misleading because of the wording: "Protect them for life. Immunise against Covid-19". Respondents argued there was no life-long protection from a Covid-19 vaccine.

Some were also concerned the use of the word "immunise" was misleading, based on how the vaccine worked, but this was not supported by the complaints board.

Most board members agreed the ads themselves did give the wrong impression, and upheld four complaints against the television advertisement, 29 complaints over the print version, and 11 complaints over the billboard and mobile phone version.

They agreed the likely consumer takeaway from the advertisement was that the Covid-19 vaccine offered life-long protection.

The Te Whatu Ora - Health New Zealand (Ministry of Health - Manat Hauora) television advertisement promoted immunisation for children, which featured the New Zealand Government and the Ministry of Health - Manat Hauora logos.

In considering this complaint, the board referred to an earlier decision regarding a longer television ad, which it did not find fault with, because it was designed to encourage parents and caregivers to take steps to protect children in their care, and did not directly reference Covid-19.

The health authority defended its ad during the complaints process and said the phrase "Protect them for life. Immunise", was developed to have a dual meaning.

It said the word "life" could be "the time between being born and death, or the experience of being alive".

Te Whatu Ora - Health New Zealand said the tagline "Protect them for life. Immunise", referred to the immunisation programme as a whole-of-life programme.

It said the campaign was developed to cover the concept of childhood immunisations and was not specific to a single vaccine, but provided overarching messaging, for example for MMR, polio, Covid-19, HPV or whooping cough vaccines.

In making its decision, the complaints board took on board the exceptional circumstances of the rapidly evolving nature of the Covid-19 pandemic.

It confirmed it would take a higher-level approach in assessing the advertising, based on the principles in the Advertising Standards Code, being the requirements for "social responsibility and truthful presentation in responsible advertising".

While some of the board members did not think the television ad was misleading, most said it had not been prepared and placed with a due sense of social responsibility to consumers and to society, considering context, medium, audience and product.

The complaints board was unanimous in its view that the message in the billboard and mobile phone ads was likely to mislead or confuse consumers, because it contained only the lines "Protect them for life", "Immunise" and the call to action to vaccinate against Covid-19.

The board said the advertisement did not have the wider context of television advertisements, which showed children being protected by parents or caregivers in different aspects of their lives.

The bulk of the complaints were against the print version of the advertisement.

The decision to uphold them was backed by the News Publishers Association, but it also noted earlier complaints about the same statement were not upheld.

The board said in addressing concerns about use of the word "immunise", and whether it was misleading, the likely consumer takeout would be that the vaccine was intended to teach an individual's immune system to recognise an infectious disease so that when exposed to that disease the immune system can fight it off.

The complaints board did not consider this element of the complaint to be misleading.

In all cases it ordered the advertisement to be removed, or not used again in its current form.

Koornneef told Open Justice that Te Whatu Ora took its commitment to responsible advertising very seriously.

She said there was no intent to mislead or confuse the public through the advertisements, which included some "very specific protection-focused vaccination messaging".

Koornneef said comments by the Advertising Standards Authority had been taken on board and would be valuable in helping to shape future campaign messaging.

"We will also continue to develop advertising campaigns and other initiatives that seek to challenge, inform, and encourage audiences, while promoting the greater protection of our tamariki through the full suite of life-saving vaccinations available," Koornneef said.

"This has never been more important, particularly as child immunisation rates continue to fall across the globe, and the impact of the Covid-19 pandemic continues to be felt."

* This story originally appeared in the New Zealand Herald.

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National health agency apologises over Covid vaccine ads it was ordered to remove - RNZ

Editorial: How Jewish space lasers and vaccine nanobots seized the brains of GOP voters  St. Louis Post-Dispatch

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Editorial: How Jewish space lasers and vaccine nanobots seized the brains of GOP voters - St. Louis Post-Dispatch

1 : a preparation that is administered (as by injection) to stimulate the body's immune response against a specific infectious agent or disease: such as a : an antigenic preparation of a typically inactivated or attenuated (see attenuated sense 2) pathogenic agent (such as a bacterium or virus) or one of its components or products (such as a protein or toxin) a trivalent influenza vaccine oral polio vaccine Many vaccines are made from the virus itself, either weakened or killed, which will induce antibodies to bind and kill a live virus. Measles vaccines are just that, weakened (or attenuated) measles viruses. Ann Finkbeiner et al. a tetanus toxoid-containing vaccine might be recommended for wound management in a pregnant woman if [greater than or equal to] 5 years have elapsed . Mark Sawyer et al. In addition the subunit used in a vaccine must be carefully chosen, because not all components of a pathogen represent beneficial immunological targets. Thomas J. Matthews and Dani P. Bolognesi b : a preparation of genetic material (such as a strand of synthesized messenger RNA) that is used by the cells of the body to produce an antigenic substance (such as a fragment of virus spike protein) Moderna's coronavirus vaccine works by injecting a small piece of mRNA from the coronavirus that codes for the virus' spike protein. mRNA vaccine spurs the body to produce the spike protein internally. That, in turn, triggers an immune response. Susie Neilson et al. The revolutionary messenger RNA vaccines that are now available have been over a decade in development. Messenger RNA enters the cell cytoplasm and produces protein from the spike of the Covid-19 virus. Thomas F. Cozza Viral vector vaccines, another recent type of vaccine, are similar to DNA and RNA vaccines, but the virus's genetic information is housed in an attenuated virus (unrelated to the disease-causing virus) that helps to promote host cell fusion and entry. Priya Kaur

Note: Vaccines may contain adjuvants (such as aluminum hydroxide) designed to enhance the strength and duration of the body's immune response.

2 : a preparation or immunotherapy that is used to stimulate the body's immune response against noninfectious substances, agents, or diseases The U.S. Army is also testing a ricin vaccine and has reported success in mice. Sue Goetinck Ambrose many of the most promising new cancer vaccines use dendritic cells to train the immune system to recognize tumor cells. Patrick Barry

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Vaccine Definition & Meaning - Merriam-Webster

08/19/2022

FDA Roundup: August 19, 2022

Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.

FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

The FDA issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

FDA Roundup: July 8, 2022

The FDA announced approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age. The agency also finalized the Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. Additionally, the agency will continue hosting virtual town halls for test developers for SARS-CoV-2 on July 27 and August 24 from 12:05 p.m. 1 p.m. ET.

Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022.

FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.

FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

FDA Roundup: April 29, 2022

On Thursday, the FDA updated the page, At-Home OTC COVID-19 Diagnostic Tests, to include expiration date information to help consumers find the current expiration date for any FDA authorized at-home OTC COVID-19 diagnostic test.

Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

Today, the FDA is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

FDA Roundup: April 15, 2022

On April 14, the FDA issued an emergency use authorization (EUA) to InspectIR Systems for their InspectIR COVID-19 Breathalyzer test. The InspectIR COVID-19 Breathalyzer test is the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection. The authorization for the InspectIR COVID-19 Breathalyzer test is an example of the FDAs continued commitment to support the development of innovative, appropriately accurate and reliable diagnostic tests that increase testing options for COVID-19.

FDA Roundup: April 1, 2022

The FDA published two FDA voices - Give Your Community a Boost: Combatting Misinformation Through Communication and Research and FDAs Technology and Data Modernization in Action in 2022. The FDA also published findings from a facility inspection of Abbott Nutrition in Sturgis, Michigan, revised the guidance: Emergency Use Authorization for Vaccines to Prevent COVID-19, denied two the request in two citizen petitions, published the FDA voices announced the extension of a public comment period, approved a new animal drug, updated a list of which regions in which the drug Sotrovimab is not authorized, approved a medical device to treat defects or legions that can occur in cartilage covering bones in the knee joint, authorized marketing of a medical device for measuring the brain temperature of neonates (infants less than four weeks old) and updated a fact sheet and FAQ regarding dosing information of Evusheld.

FDA Roundup: March 29, 2022

Today, the FDA authorized a manufacturing change for the Moderna COVID-19 Vaccine to include an additional presentation of the vaccine for booster vaccination doses only.

Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.

Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.

FDA Roundup: March 11, 2022

As part of the FDAs effort to protect consumers, on March 7, the agency issued a warning letter jointly with the Federal Trade Commission to Viraldine, LLC for selling unapproved products with fraudulent COVID-19 claims. On March 4, the FDA authorized an extension for the shelf life of the refrigerated Janssen COVID-19 Vaccine, from six to nine months, allowing the product to be stored at 2-8 degrees Celsius. Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.

FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

The FDA has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. Based on the agencys preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.

Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

FDA Takes Key Action By Approving Second COVID-19 Vaccine

The FDA approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.

FDA Roundup: January 11, 2022

The FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension).

Coronavirus (COVID-19) Update: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

Today, the FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.

FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

The FDA amended the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to take several actions that will expand the use of the vaccine in certain populations.

Coronavirus (COVID-19) Update

The FDA approved a manufacturing change for Comirnaty to include a formulation that uses a different buffer; and an abbreviated new drug application for increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines (a class of neurotransmitters).

Coronavirus (COVID-19) Update

The Janssen COVID-19 fact sheets have been updated to include contraindications for people with a history of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored COVID-19 vaccine.

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

Today, the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

FDA is working with federal partners, international regulators and medical product companies to quickly address any potential impacts of the omicron variant.

FDA Expands Eligibility for COVID-19 Vaccine Boosters

The FDA amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

Coronavirus (COVID-19) Update

The FDA discussed the agencys actions to expand the use of a single booster dose for COVID-19 vaccines in eligible populations. In addition, the FDA authorized the 11th over-the-counter (OTC) COVID-19 test and is investigating certain imported medical gloves that appear to have been reprocessed, cleaned or recycled and sold as new.

FDA Authorizes COVID-19 Vaccine in Children 5 through 11

The authorization was based on the FDAs thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

Vaccines and Related Biological Products Advisory Committee Meeting

The committee will discuss a request to amend Pfizer-BioNTechs Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. View livestream.

Coronavirus (COVID-19) Update

Today, the FDA began posting materials for the next Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting, happening on Tuesday, Oct. 26. The committee will meet in open session to discuss a request to amend Pfizer-BioNTechs Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.

FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

The FDA took additional actions regarding booster doses of COVID-19 vaccines, including authorizing heterologous (or mix and match) booster doses in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine. Listen to media call.

Vaccines and Related Biological Products Advisory Committee Meeting

The committee will discuss the Emergency Use Authorization (EUA) of the ModernaTX Inc. COVID-19 vaccine and the Janssen Biotech Inc. COVID-19 vaccine for the administration of an additional dose, or booster dose, following completion of the primary series, to individuals 18 years of age and older. View October 14 livestream. View October 15 livestream.

FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children

The FDA is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.

Coronavirus (COVID-19) Update

The FDA authorizes an emergency use authorization for one additional batch of the Janssen COVID-19 vaccine and the FDAs Acting Commissioner, Dr. Janet Woodcock, discusses the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

Stakeholder Call: Pfizer-BioNTech COVID-19 Vaccine Booster Dose

Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the Pfizer-BioNTech COVID-19 Vaccine booster dose.

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series with the Pfizer-BioNTech COVID-19 Vaccine in certain populations.

Podcast: COVID-19 Vaccine Boosters and COVID-19 Vaccines for Kids

Acting FDA Commissioner Dr. Janet Woodcock discusses additional shots of the COVID-19 vaccine ("boosters") and COVID-19 vaccines for kids under 12

Coronavirus (COVID-19) Update

The FDA took the following actions in the agencys ongoing response to the COVID-19 pandemic: issued a Letter to Health Care Providers about the potential for false positive results with Abbott Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits; revised the Emegency Use Authorization (EUA) for bamlanivimab and etesevimab, administered together, to include an emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms) who are at high risk for progression to severe COVID-19; issued a revised guidance to help expand the availability of face masks, barrier face coverings and face shields for the general public, including health care personnel, as well as surgical masks and particulate filtering facepiece respirators (FFRs) (including N95 respirators) for health care personnel for the duration of the COVID-19 public health emergency; and authorized the use, under the EUA for the Janssen COVID-19 vaccine, of two additional batches of vaccine drug substance manufactured at the Emergent facility.

Vaccines and Related Biological Products Advisory Committee

The Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older. View livestream.

Coronavirus (COVID-19) Update

The FDA approved an abbreviated new drug application indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting, authorized the use--under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine--of one additional batch of vaccine drug substance manufactured at the Emergent facility, and issued a revised guidance which provides general recommendations to prospective generic drug applicants in the form of questions and answers that have been addressed during the COVID-19 public health emergency. The FDA also posted a statement titled FDA Will Follow The Science On COVID-19 Vaccines For Young Children.

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children.

FDA's Dr. Janet Woodcock on COVID-19 Vaccines and Treatments

Acting FDA Commissioner Janet Woodcock, M.D.,discusses COVID-19 vaccines for kids, additional vaccine doses, and the latest on COVID-19 treatments with WebMD.

FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTechs Application for COVID-19 Booster

Today, the U.S. Food and Drug Administration announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the matter of additional doses of COVID-19 vaccines and specifically to discuss the Pfizer-BioNTech supplemental Biologics License Application for administration of a third (booster) dose of Comirnaty (COVID-19 Vaccine, mRNA) in individuals 16 years of age and older.

Coronavirus (COVID-19) Update

The FDA updated the Pfizer-BioNTech emergency use authorization (EUA) to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months.

FDA Approves First COVID-19 Vaccine

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Public health and medical experts from the U.S. Department of Health and Human Services released a statement on the Administrations plan for COVID-19 booster shots for the American people.

Coronavirus (COVID-19) Update

A new FDA Consumer Update highlights 5 Things to Know about COVID-19 Vaccination for Adolescents and FDAs vaccine expert, Dr. Peter Marks, participated in the HHS Ask An Expert video series to answer some of your most frequently asked questions about COVID-19 vaccination.

FDA Authorizes Additional Vaccine Dose for Immunocompromised People

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Coronavirus (COVID-19) Update

Today, FDA announced that it has found certain lots of Astra Zeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccine made from the lots, will now be exported for use.

Coronavirus (COVID-19) Update

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COVID-19 Vaccines | FDA

Novavax COVID-19 vaccine available for ages 12 and up; CDC Community Level back at Low

NEW HANOVER COUNTY The New Hanover County Pandemic Operations Center is now offering the Novavax COVID-19 vaccine to those 12 and older.

This week, the Food and Drug Administration expanded Emergency Use Authorization to Novavax, adding eligibility to those 12-17 years old. The Centers for Disease Control and Prevention also agreed with the recommendation.

As everyone is getting ready to head back into a classroom, it is important to know there is now another option for kids and teens to get vaccinated, said Pandemic Operations manager Jon Campbell. COVID-19 can be transmitted through the air and the more people you have in an indoor space, the more virus particles can be transmitted. So as students are sitting in classrooms, its important to keep in mind the things that can keep them safe like vaccinations and improving ventilation where possible.

At this time, Novavax is a primary series vaccination and is not authorized for use as a booster.Anyone 12 and older that is not yet vaccinated, is now eligible to receive the Novavax COVID-19 vaccine.This is a 2-dose series given 3 weeks apart.

Novavax and all other COVID vaccines are being offered free of charge at the Pandemic Operations Center (1507 Greenfield Street in Wilmington), along with boosters, and testing. Members of the community are also encouraged to pick up free at-home tests and masks at the center during operating hours.

Appointments are recommended but not required and can be made by visitingTakeMyShot.NC.gov. Vaccines and boosters will be available during the following days and times:

The Pandemic Operations Center is also offering no cost rapid testing. An appointment is recommended and can be made by visitingthis link,but again it is not required. Rapid tests will be available during the following days and times:

For more information on the Pandemic Operations Center, vaccines, boosters, or testing, visitHealth.NHCGov.com/Coronavirusor call the Pandemic Operations Call Center at 910-798-6800.

Community Level returns to Low

New Hanover County is back in the Low CDC Community Level this week after being in Medium for most of the summer. Declining case rate in New Hanover County has allowed for the change in level. This weeks case rate fell below 200 cases per 100,000 for the first time in seven weeks. New Hanover County moved to the Medium Community Level back on July 8 and has remained there since.

Getting back into the Low CDC Community Level is something to celebrate, said Campbell. The impact to our healthcare system has remained low showing that as the virus changes a combination of the protective measures, we have available, like the vaccine, have been able to help prevent severe illness and now our case rate is falling as well. We are getting ready to move into cooler weather and more indoor activities where we know viruses like COVID-19 can thrive, so celebrate the low level but remember that preventative measures like vaccines, hand washing, and proper ventilation indoors can keep us here.

Recommended precautions for a Low Community Level include being fully vaccinated and boosted, and testing for COVID if you develop symptoms. Mask usage at this community level is optional. The CDC plans to update community levels weekly, so residents can check the CDC website here to know the current community impact level.

COVID-19 Community Data, as of August 26:

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Novavax COVID-19 vaccine available for ages 12 and up; CDC Community Level back at Low - Communications and Outreach - New Hanover County

The U.S. Department of Agriculture has initiated its annual oral rabies vaccine distribution, a project that will continue through October. The project is focused on preventing the spread of raccoon rabies from the eastern United States into the heartland, according to a news release from the USDA.

This year's distribution started on August 6. If you've gotten your dog vaccinated for rabies, you probably remember taking it to the veterinarian to get a shot. But these rabies vaccines are edible pellets covered in fishmeal to attract raccoons and other hungry critters.

In rural areas, the USDA will distribute the vaccines by airplane. In suburban and urban areas, they'll arrive by helicopter or vehicle or be deposited by hand in designated "bait stations," says the release.

The August phase of the program is focused on Maine and West Virginia. Approximately 348,000 vaccines will be distributed in northern Maine and 535,000 distributed in parts of western Pennsylvania, West Virginia, and a small portion of southwestern Virginia.

Then from mid-September to mid-October, 70,000 vaccines will be distributed in parts of peninsular Massachusetts.

Finally, in October southern states will receive their rabies vaccines. Parts of North Carolina, Tennessee, and Virginia will receive more than 880,000 vaccines; Alabama, Georgia, North Carolina, South Carolina, and Tennessee will receive around 820,000 vaccines; and parts of Alabama will include 1.1 million vaccines.

The oral vaccine, also called RABORAL V-RG, has been found to be safe in over 60 animal species, says the USDA. This includes domestic dogs and cats, so you don't need to worry much about your beloved pet snacking on one of the vaccines. Dogs that eat large number of the vaccines may have stomach problems -- but they won't have any long-term health consequences, according to the USDA.

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The USDA is sprinkling fish-flavored vaccines from the sky to fight rabies - CNN

And that whole process from end to end can be immensely expensive, cost billions of dollars and take, you know, up to a decade to do that. And in many cases, it still fails. You know, there's countless diseases out there right now that have no vaccine for them, that have no treatment for them. And it's not like people haven't tried, it's just, they're, they're challenging.

And so we built the company thinking about: how can we reduce those timelines? How can we target many, many more things? And so that's how I kind of entered into the company. You know, my background is in software engineering and data science. I actually have a PhD in what's called information physicswhich is very closely related to data science.

And I started when the company was really young, maybe a hundred, 200 people at the time. And we were building that early preclinical engine of a company, which is, how can we target a bunch of different ideas at once, run some experiments, learn really fast and do it again. Let's run a hundred experiments at once and let's learn quickly and then take that learning into the next stage.

So if you wanna run a lot of experiments, you have to have a lot of mRNA. So we built out this massively parallel robotic processing of mRNA, and we needed to integrate all of that. We needed systems to kind of drive all of those, uh, robotics together. And, you know, as things evolved as you capture data in these systems, that's where AI starts to show up. You know, instead of just capturing, you know, here's what happened in an experiment, now you're saying let's use that data to make some predictions.

Let's take out decision making away from, you know, scientists who don't wanna just stare and look at data over and over and over again. But let's use their insights. Let's build models and algorithms to automate their analyses and, you know, do a much better job and much faster job of predicting outcomes and improving the quality of our, our data.

So when Covid showed up, it was really, uh, a powerful moment for us to take everything we had built and everything we had learned, and the research we had done and really apply it in this really important scenario. Um, and so when this sequence was first released by Chinese authorities, it was only 42 days for us to go from taking that sequence, identifying, you know, these are the mutations we wanna do. This is the protein we want to target.

Forty-two days from that point to actually building up clinical-grade, human safe manufacturing, batch, and shipping it off to the clinicwhich is totally unprecedented. I think a lot of people were surprised by how fast it moved, but it's really We spent 10 years getting to this point. We spent 10 years building this engine that lets us move research as quickly as possible. But it didn't stop there.

We thought, how can we use data science and AI to really inform the, the best way to get the best outcome of our clinical studies. And so one of the first big challenges we had was we have to do this large phase three trial to prove in a large number, you know, it was 30,000 subjects in this study to prove that this works, right?

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I Was There When: AI helped create a vaccine - MIT Technology Review

In a bid to curb the spread of SARS-CoV-2, the virus that causes COVID-19, public health experts have been pushing for a fast and effective vaccine rollout. However, some members of the public have been hesitant to take up vaccines. What happened, and is there something that science communicators keep getting wrong about vaccine hesitancy?

Millions of people around the world have now received a vaccine for COVID-19, yet for many the decision was not an easy one indeed, some people are yet to accept a COVID-19 vaccine, even though it is available to them.

Some researchers have named this phenomenon vaccine hesitancy the European Centre for Disease Prevention and Control (ECDC) defines it as the delay in acceptance or refusal of vaccines despite availability of vaccination services.

But what renders people unsure about accepting any given vaccine? And is vaccine hesitancy something that science communicators can help resolve?

Theories about the reasons behind peoples vaccine-related worries abound, and they may all hold some truth. Some researchers surmise that what makes people hesitant about whether or not they should accept a vaccine is the lack of access to accurate, complete information about that vaccine.

Others say that it all comes down to the spread of willful dis- and misinformation about vaccination. Yet others point out that, during the COVID-19 pandemic, those belonging to some historically marginalized communities, such as Black Americans, were the most likely to be hesitant about COVID-19 vaccines.

This is due to a long history of medical experimentation and gaslighting experienced by this community, as well as to present experiences of racism and discrimination when attempting to access healthcare.

But the lack of trust in scientists and public health authorities spreads much farther and deeper, and it may be a core factor in vaccine hesitancy around the world.

In this installment of the In Conversation podcast, we spoke with Prof. Maya Goldenberg, who is a professor of philosophy at the University of Guelph in Ontario, Canada, and the author of Vaccine Hesitancy: Public Trust, Expertise, and the War on Science.

We were also joined by reporter Aaron Khemchandani, who is a science communication MSc student at Imperial College London in the United Kingdom, and who has studied the phenomenon of mistrust in science.

This feature is based on an edited and shortened record of the discussion featured in our podcast. You can listen to the podcast in full below or on your preferred platform.

In her book, Prof. Goldenberg explains that vaccine hesitancy is a spectrum phenomenon people may feel anywhere from vaguely uncertain about whether or not a vaccine is safe and effective, to very anxious about its potential effects.

Yet the concept itself, she explains, is a fairly new one for public health experts to focus on historically, public health institutions have focused on recording rates of vaccine refusal rather than looking at what makes people hesitant about accepting vaccines, regardless of their final decision.

Understanding what drives vaccine hesitancy, however, is far more helpful when it comes to promoting public health, Prof. Goldenberg argues. Firstly, she writes, understanding peoples misgivings about vaccines and allaying those fears can help boost vaccine uptake.

Secondly, failing to effectively communicate with people about what makes them hesitant when it comes to vaccination can actually make up their minds to refuse it.

So what are the factors that drive vaccine hesitancy? The COVID-19 pandemic has made one of them clear: Many people around the world do not trust national and international health authorities, often for complex reasons.

In our latest podcast episode, Aaron Khemchandani gave the situation in Hong Kong as an example, explaining that the mistrust in governmental institutions initially led to low COVID-19 vaccine uptake. However, the ensuing rise in COVID-19 cases eventually flipped the script, Aaron noted.

[P]eople decided that the vaccine was important to protect the community, and community is one of the values that, especially in East Asia, is widely prioritized among the population. From the start of the pandemic, [in] Hong Kong mask wearing was widespread, because masks [] protect other people from you, so people wanted to protect their loved ones, he explained.

[T]hat just showed how [much] Hong Kong valued protecting the wider society, and so vaccines became part of that when [COVID-19] case numbers started to rise, Aaron added.

While the outcome here is a positive one, for Prof. Goldenberg, the initial resistance to vaccines in Hong Kong was very telling about the way in which peoples relationship with institutions can influence their views about, and trust in, medical interventions.

The things that really stand out to me from this account from Hong Kong, she told us, is the way that general trust in government and social structures influence opinions about vaccines.

[T]his goes against the common thinking that people who dont vaccinate somehow dont understand the science, or have some kind of cognitive break that keeps them from doing the right thing. Instead, theres lots of social science research, not just in Hong Kong, but in many countries, pre-COVID and during COVID, showing that a persons trust in government, especially [in a] government dealing with a crisis is largely correlated with your likelihood to get vaccinated. [] You have to trust the system that brings you vaccines, in order to be willing to participate in [vaccination programmes].

Prof. Maya Goldenberg

Its not about understanding science, [] its about trusting the scientific and regulatory process that is bringing us vaccines and telling us that [they are] safe and effective, and something that we should [accept]. If you dont trust the system, youre not going to trust the vaccine, she pointed out.

While it may be helpful to think about hesitancy rather than refusal when it comes to understanding the factors that influence vaccine uptake, not everybody agrees that the term vaccine hesitancy is a useful one in every context.

For some, it is a misnomer that fails to acknowledge the fact that medical institutions themselves are sometimes to blame for the low uptake of vaccines in the community.

[T]here were serious political complaints about the use of the term when, lets say, there wasnt enough access [to] vaccines [among] marginalized groups, Prof. Goldenberg told us.

And politicians would say, well, theyre just vaccine-hesitant. And people from within those communities would say, well, thats [a] lazy use of the term, we have an access problem, we dont have a vaccine hesitancy problem, and theyre using [the term] as a slide for not taking responsibility, for the lack of infrastructure, for the lack of supports for people who are not fully integrated into the system, she explained.

In fact, in the United States and elsewhere in Western countries, the people who have been disproportionately affected by COVID-19 throughout the pandemic are those belonging to historically marginalized communities, such as migrants, Black and Hispanic individuals, and those with undocumented status.

Oftentimes, individuals belonging to these communities work in customer-facing roles that increase their risk of infection, may face less safe living conditions such as overcrowded housing, and may have limited or no access to timely healthcare.

Even when they do have access to vaccines, people belonging to marginalized groups may still be hesitant to take them. Why is that?

According to research looking at vaccine hesitancy among Black adults in the U.S., their views on vaccination are tied to the long legacy of systemic racism in the U.S. healthcare system.

Both historical and recent personal experiences of discrimination in healthcare have rendered many Black adults less likely to trust the health system and healthcare providers who do not understand their needs and may often perpetuate harmful stereotypes.

I think [the experience of current and historic discrimination is] a major driver of vaccine hesitancy, Prof. Goldenberg told us. I think it was like that before COVID, but it somehow became more visible to the public [during the pandemic.

I remember near the beginning of [the] COVID [pandemic], they had done a lot of survey research, when the COVID vaccines become available, [asking] will you get vaccinated?, she recalled, and it was treated as a surprise that marginalized groups who were suffering the most from COVID, [the] people that couldnt work from home, lived in housing conditions that [werent] conducive to social distancing, [] were the least likely to get vaccinated.

And it shouldnt have been treated as a shock, because I think the knowledge about mistrust of healthcare and government among marginalized communities was already there. Its just that the links hadnt been made between healthcare decision-making and experiences of marginalization. Truth is, we dont even need to look that far back to famous case studies, like the Tuskegee syphilis studies you can look at the experiences of [] people in healthcare today to understand why theyre not front in line there []

Prof. Maya Goldenberg

It is difficult to deny that vaccine hesitancy is also complicated by wilful mis- and disinformation spread by influencers with questionable agendas.

In our discussion, Aaron mentioned the disproportionate impact of the so-called Disinformation Dozen in 2021, the Center for Countering Digital Hate (CCDH) published the results of an investigation that found that most of the disinformation spread about COVID-19 vaccines online at that time had originated from no more than 12 active social influencers.

In todays fast-paced digital age, altered information can spread very fast and do much harm. However, while she acknowledged the impact of mis- and disinformation, Prof. Goldenberg cautioned that we must be wary of blaming lack of trust in vaccines exclusively on the wrong information that easily circulates online.

There will always be bad social actors who spread health myths, she noted, and simply debunking those myths over and over will not be enough to restore the trust in health institutions, she argued.

Prof. Goldenberg also thought that some people may be attracted to these bad actors precisely because they place themselves in the role of fighters against an oppressive system and that is what we need to address.

[T]hat, for some reason, resonates with a lot of people and people who have experience of [how] this system fails them the American dream is not something that they feel is within reach for them. So we need to look at the sort of social structures that create this level of dissatisfaction, she emphasized.

I look at all the time spent debunking the myths being propagated by these disinformants, and its almost beside the point. Its not that we should let this disinformation linger [] But the point is, its just going to move from one [source] to another, you shut down one source another one will open up because theres an appetite for it. You debunk one myth, its OK, another one will pop up in its place because people are looking for that kind of outlet. [] [W]hatever hurts that they are feeling they want to place it on something, and placing it on these kinds of disinformation and conspiracy theories [is] a way to have it all make sense []

Prof. Maya Goldenberg

So if a lack of trust between the public and health experts and organizations is the core driver for vaccine hesitancy, how can we repair that trust?

Recent research suggests that what is most important for scientists, organizations, and individuals is to communicate with empathy, above all.

Theres been good research demonstrating that the way to talk to people about vaccines is, first of all, not to try to convince them otherwise, and not to ply them with the facts, said Prof. Goldenberg.

A sympathetic approach is what works, you have to hear them out, listen to what they have to say, try not to be judgmental about it that is hard to do sometimes because were all kind of tired and would like things to go a little easier. But the best thing to do is listen to what they have to say, respond not with the fact-based approach [] but [instead] ask more questions and try to find out where the source of the misgivings [lies]. There might be concrete pieces of misinformation, perhaps you can deal with that. But it needs to be done in a respectful way, the same way you would want to be spoken to by someone who disagrees with you.

Prof. Maya Goldenberg

Its more about try[ing] to meet them on common ground, she noted.

Vaccine mandates may push some people to get vaccinated in the short term, but in the long term they will do little to report the trust between the public, the government, and health organizations, Aaron also pointed out.

[Goverment-mandated restrictions] did increase the vaccine rate, but didnt do anything to repair the trust between citizens and the government, because it was sort of done out of necessity and fear, as opposed to sharing any sort of values with government officials and their plan for success in [the COVID-19 pandemic], he explained.

Aaron was in agreement with Prof. Goldenberg that empathy is key, and science communicators need to shift the way in which they approach vaccine hesitancy to put individuals and their experiences first:

I think the most important thing is to find common ground, just to find shared values, understand people, understand them as people, as opposed to just [thinking of them as] statistics, [] understand historical context, empathize.

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Vaccine hesitancy and trust in health experts: Shifting the focus - Medical News Today

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Q&A: The new COVID vaccine booster is coming. Should you get it? - The Lawton Constitution

Daly Walker

It started out like a normal summer day for 8-year-old Daly Walker.

It was 1949, and the future Columbus Regional Hospital surgeon was playing Little League baseball in the town of Winchester, Indiana, unaware that his life was about to change.

While on the baseball field, he suddenly started feeling sick. I actually collapsed, Walker, now 81, recalled 73 years later in an interview with The Republic. I had a fever, and I was very weak. It was a very rapid onset. The coach carried me off the field. I was dizzy, and I was vomiting.

What nobody knew at the time was that one of the most feared viruses in the world had invaded his body and was attacking his brain stem.

Walker said he was rushed to a local doctor who performed a spinal tap, a test in which a needle is inserted between two lumbar bones to remove a sample of fluid that can be used to diagnose medical conditions.

It didnt take long for the doctor to figure out what was wrong: Walker had contracted polio, a disabling and life-threatening disease with no cure that struck fear in hearts of parents for decades during the first half of the 20th century.

While most infected people would have no visible symptoms, some children would develop an infection of the covering of the spinal cord or brain, according to the Centers for Disease Control and Prevention. Others would develop paralysis in the arms or legs. Many polio survivors including former President Franklin D. Roosevelt were disabled for life.

Walker was taken to a hospital in nearby Muncie. He was soon joined by his older sister, who had also contracted polio, though she was not as sick as him and recovered. We were in the same hospital room for a while, he said.

Big epidemic in Indiana

Walker, however, was just one of many children in Indiana who were stricken with the disease.

By the time he contracted the virus in late 1940s, polio outbreaks in the U.S. were increasing in frequency and size, disabling an average of more than 35,000 people, including more than 15,000 cases of paralysis, each year, according to the CDC.

Outbreaks periodically swept through cities and towns of all sizes. Walker said his father, who was a funeral director in the town of Winchester, buried 11 polio victims, including a young couple who left behind two children.

There was a big epidemic in Indiana, Walker said. Riley Hospital was filled with children on iron lungs and paralyzed, as were other hospitals in the state.

And Bartholomew County was no exception.

News coverage in The Republic at the time depicted periodic local outbreaks of polio and a state of fear hanging over the community.

Parents were scared to let their children go outside, particularly in the summer, when incidence of the disease was believed to peak. Public health officials would impose quarantines on homes and towns.

In 1946, health officials in Columbus closed all city playgrounds and pools, canceled Little League baseball games at Donner Park and barred anyone under the age of 18 from going to theaters after three cases of polio were confirmed in Bartholomew County.

At least four Bartholomew County residents including three small children died from polio in a two-month period in the fall of 1952.

By 1957, the National Foundation for Infantile Paralysis said there were 52 polio victims living in Bartholomew County, according to Columbus Regional Health.

It affected children more

Motivated by his battle with polio, Walker became a physician, graduating from the Indiana University School of Medicine in 1966. Just a few years later, he moved to Columbus to take a job as a surgeon at CRH, where he worked for decades.

And now, decades after being hospitalized with polio, Walker received the news of the first case of the disease in the U.S. in nearly a decade with a heavy heart. Last month, an unvaccinated young adult in New York contracted the virus and developed paralysis, The Associated Press reported.

Just a few weeks later, New York state and federal officials confirmed that the virus that causes polio had been detected in New York Citys wastewater in another sign that the disease is quietly spreading among unvaccinated people, according to wire reports.

Recently, an unvaccinated young adult north of New York City contracted polio. On Friday, health officials in the nations largest city said they had found the virus in wastewater samples, suggesting it was spreading among the unvaccinated.

And an estimated 886 children ages 19 to 35 months in Bartholomew, Jackson and Jennings counties were behind on their polio shots as of this past March, state records show.

Its very sad to think this is coming back, Walker said. It can attack anybody, but they called it originally infantile paralysis because it affected children more than adults. Its a problem for the pediatric population. Id hate to see it resurrect itself again.

Spared the worst

Walker said he was spared the worst consequences of polio. Because the virus attacks the brain stem which controls breathing and swallowing many children had to be put on ventilators called iron lungs to help them breath.

Fortunately, my respiratory center was spared, so I did not go on an iron lung, although there were a couple nights when I had trouble breathing, Walker said. My main problem was that my swallowing mechanism was paralyzed. So, I was unable to eat on my own. I was fed for many, many months by my mother (through a tube into his stomach.)

In an interview 20 years ago with The Republic, Walker said his family set up a hospital bed for him in their dining room, and their house was put under quarantine. They posted the notice on our front door, Walker said in 2002. People would cross the street so that they didnt have to walk close to our house.

Eventually, Walker was able to regain the ability to swallow, though somewhat impaired, and was able to live a normal life. But he still remembers the young couple who died of polio that his father buried some 70 years ago and the two children who were orphaned.

Introduction of vaccines

But everything changed in 1955, when the first polio vaccine was introduced.

When the polio virus vaccine was approved and was starting to be used, the whole community rejoiced, Walker said, recalling how Winchester residents reacted to the news. They were just ecstatic about that. They rang the church bells and cars drove around honking horns. When the announcement was made, my mother wept because she was so happy the other children and other families who wouldnt have to experience what we had.

By April 1955, almost 85% of parents of first and second graders in Bartholomew County had given permission for their children to get the vaccines, according to news coverage at the time. Later that month, more than 1,600 of those students had gotten their first dose.

The publics reaction to the polio vaccine was different than it was for the COVID-19 vaccine, which many people in Bartholomew County still havent gotten. But that was a different era, Walker said.

We had just come out of World War II and people, really as a nation, were united and working together to better our country, Walker said. So, things like polio they attacked with a vengeance like they did World War II.

Following the introduction of vaccines, the number of polio cases in the U.S. fell rapidly to less than 1,000 cases in 1962, less than 100 in the 1960s and fewer than 10 in the 1970s.

In 1979, the U.S. officially declared that polio had been eliminated in what has been viewed as one of the nations greatest public health victories, according to the CDC. Yet cases have cropped up occasionally since then, often among people who had traveled to other countries.

Walker, who became a writer after retiring and now spends his time between Florida and Vermont, developed post-polio syndrome a few years ago and his symptoms got worse. He underwent a procedure and was able to feel better, though I just have to be a little careful.

Walker is urging people to take the virus seriously and to get vaccinated.

Im just disheartened to learn that its cropping up again and people arent getting vaccinated, Walker said.

Its such a devastating illness, and the people that survived it with paralyzed legs and arms had a hard life after that, he added later in the interview. Although I was very ill, I was lucky that I didnt have any paralysis on my extremities.

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Former CRH surgeon who survived polio disheartened by vaccination lapses - The Republic