Novavax clinical trial
While Novavax hasnt yet sought approval by the Food and Drug Administration (FDA) for its more conventional Covid-19 vaccine, it has recently applied for licensing its vaccine in Australia, Canada, Indonesia, New Zealand, and the U.K. This hasnt gained much traction in the U.S. media, which is odd, given that Novavaxs vaccine could not only help close the equity gap in vaccinations worldwide, but it may also help convince some who are vaccine hesitant to get vaccinated.
If Novavax does submit a marketing application in the U.S. and the FDA approves, the Novavax vaccine has the potential to boost chances of overcoming doubts on the part of the vaccine hesitant. Its a vaccine without the baggage, if you will, of a new technology which people arent familiar with, and may therefore not feel comfortable receiving.
Earlier this week the virologist Dr. Angela Rasmussen tweeted: Ive talked to some unvaccinated folks here in Canada and the U.S. who stated theyd reconsider their position if a more traditional (not mRNA or viral vectored) vaccine were available.
About 57% of the U.S. adult population is fully vaccinated; leaving 43% either partially vaccinated or unvaccinated. Approximately 65 million Americans have had no vaccinations whatsoever.
In the U.S., stubborn vaccine hesitancy has helped shape the trajectory of the Delta variant wave. Peer nations blasted past the U.S. in vaccinating their populations just prior to and during the Delta waves initial onslaught. Adjusting for population, the daily death rate during the Delta wave was about eight times higher in America than in other wealthy nations.
At present, most of the media attention with respect to Covid-19 is on vaccinating en masse children between the ages of five and 11. President Biden tweeted: We have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5-11. But, one wonders whether this really represents a turning point of significance. Additionally, one can question whether there may be some misplaced emphasis on vaccinating young children rather than redoubling efforts to vaccinate the still unvaccinated adults, that is, continuing to try and reach as many unvaccinated folks as possible.
Perhaps theres a sense that further attempts to persuade the unvaccinated will just encounter entrenched resistance. Multiple factors contribute to vaccine hesitancy. Some are more nefarious than others, like intentional misinformation. Other factors arent deliberate deception. Rather, theyre shaped by fear of the unknown, as a new kind of vaccine, namely mRNA, is being used in the real world for the first time.
Viral vector and mRNA Covid-19 vaccines have thus far been the work horses in Western countries. But, these are not the typical vaccines people are accustomed to from childhood. This particularly applies in the case of mRNA vaccines where the only active ingredient is the messenger ribonucleic acid (mRNA), which trains a persons body to recognize and kill the virus.
The Novavaxs Covid-19 vaccine candidate, named Covovax, could be the first approved in the U.S. to rely on a traditional, tried-and-true inoculation method. Its protein-based Covid-19 vaccine employs whats called recombinant nanoparticle technology, distinguishing it from mRNA and viral vector vaccines.
The purified protein, or protein subunit approach which Novavax used to develop its vaccine has been deployed in other vaccines that have been on the market for several decades. The Hepatitis B vaccine, for example, is a subunit agent.
But, the subunit type of vaccine is not the only traditional vaccine. In fact, when people speak of traditional vaccines with long histories theyre referencing a slew of types, from killed and inactivated, to live attenuated, to protein subunit.
An inactivated vaccine consists of virus particles, bacteria, or other pathogens that have been grown in culture and then killed to destroy disease producing capacity. Live vaccines use a weakened (or attenuated) form of the germ that causes a disease. Unlike live attenuated or an inactivated vaccine, a subunit vaccine contains purified parts of the pathogen that are antigenic, or necessary to elicit a protective immune response.
The polio vaccine is a typical example of an inactivated vaccine, as is the combination diphtheria, tetanus, and pertussis vaccine. The combination measles, mumps, and rubella vaccine is a live attenuated agent. Influenza vaccines can be both inactivated and live attenuated.
In September, Novavax applied to the World Health Organization (WHO) for an emergency use listing of its coronavirus vaccine. The company expects to soon be a major distributor to lower and middle-income countries, given that the vaccine has much less onerous storage requirements than the others on the market. Novavax is partnering with the Serum Institute of India on the WHO application, which could facilitate getting the vaccine to countries supported by COVAX, a coalition of international vaccine organizations that are collaborating to provide equitable global access to vaccines.
But, manufacturing concerns continue to plague the company. In fact, production problems at a Novavax facility in Maryland have led to delays in the COVAX vaccine sharing program.
As Novavax continues to work through these issues, the manufacturing delays may be partly to blame for Novavax not yet submitting an application for approval to the FDA. If ultimately approved, Novavax will need to be able to produce at scale in order to have the vaccine serve a dual role: Reducing vaccine hesitancy at home, while helping the global push for vaccination.
Full coverage and live updates on the Coronavirus
HONESDALE, Pa. Children and others can get their COVID-19 vaccine in Wayne County.
Wayne Memorial Community Health Centers is hosting a clinic this Saturday, November 6, from 9 a.m. to noon at the Stourbridge Medical Complex on Maple Avenue in Honesdale.
Children from five to 11, teenagers, and adults can all get vaccinated.
You must register online.
WILLIAMSON COUNTY, Texas (KXAN) Health officials are making big plans to get shots in little arms across Central Texas.
This comes after federal health officials gave the final approval for a kid-size dose of the Pfizer vaccine to be used for 28 million children who are ages 5 to 11.
In Williamson County, there are about 68,000 children now eligible to get the vaccine.
It was a matter of just picking the day and scheduling it. It was incredible easy, said Jessamy Rose.
Roses 9-year-old daughter is one of the first in line. Shes looking forward to fewer close calls at school.
Her class, twice, got the email that she was in close contact with someone that had a confirmed COVID case, said Rose.
Walgreens, H-E-B, pediatric offices and local heath districts are where parents are finding the vaccine. The Williamson County and Cities Health District says it doesnt expect a shortage in vaccines this time around.
Theres a about 18 providers in the area including us, said Kaitlin Murphee, WCCHD clinical services director. Here at the health district, we are receiving 100 doses. There are some providers that are getting up to 2,400.
WCCHD plans to begin administering vaccines starting Monday, Nov. 8. Theres also a tremendous relief for school districts.
WCCHD clinics will be offering COVID vaccinations for 5-11-year-olds beginning the week of Nov. 8. Call 512-943-3600 to schedule an appointment. https://t.co/yOPMacoR5E
The anxiety of not having this vaccination for our 5 to 11 year olds has been the top of our list, said Cristin Wicketts, Leander ISD district nurse. Were really excited about having this opportunity now.
Leander ISDs head nurse has scheduled their first 5 to 11 year old vaccine clinic for Saturday. There are 1,000 doses already in hand, and any student, even outside the district, is welcome.
The clinic will be held at the Leander Extended Opportunity Center located at 300 West South Street from 1 to 5 p.m. The district says appointments arent required, but parents should look for a form on the district website to fill out prior to arrival.
In Round Rock, the school district is also preparing for future clinics in November and December.
This is what weve been waiting for. The term game changer is overused, but its applicable here, said Jenny Caputo with Round Rock ISD communications.
The Centers for Disease Control and Preventions (CDC) endorsement of the Food and Drug Administrations (FDA) emergency use authorization for the Pfizer COVID-19 vaccine to prevent severe illness and complications related to Coronavirus Infectious Disease 19 (COVID-19) in children 5 to 11 years old is a major step in the battle against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2), the virus that causes COVID-19.
The decision by the CDC is not only good news for children, but it is exciting news for families, schools, and the community at large, says Dr. Matifadza Hlatshwayo Davis, Director of Health for the City of St. Louis. It could mean larger yet safe end of the year holiday gatherings for families, fewer interruptions to in-person learning for students attending primary and secondary schools (elementary, middle and high school), and a reduction in cases and deaths associated with SARS CoV-2 infection in City of St. Louis communities.
The City of St. Louis Department of Health is partnering with Federally Qualified Health Centers, city schools, hospital systems, and community-based organizations to ensure parents and caregivers have opportunities to obtain COVID-19 vaccinations for their eligible children. Affinia Healthcare, SSM Health and BJC are examples of Department of Health partners who will be working to make sure vaccines are equitably distributed throughout the city and barriers to access are eliminated.
A full list of partners, a schedule of available testing and vaccination sites, and available wrap-around services will be released following the Missouri Department of Health and Senior Services updating its guidance. The list of partners will include the organizations the Department of Health will collaborate with to assist all schools in the City of St. Louis with vaccination efforts. This information will also be available on the City of St. Louis Department of Healths website https://www.stlouis-mo.gov/covid-19/. If you have questions, please contact the Department of Health by phone (314) 657-1499 or email health@stlouis-mo.gov.
FORIMMEDIATERELEASENov. 2, 2021Contact: ODH Office of Communications 614-644-8562
COVID-19 Vaccines Will Soon Be Available to Ohioans Ages 5-11 Years Old
COLUMBUS Following the U.S. Food and Drug Administration (FDA) granting an emergency use authorization (EUA) to the Pfizer-BioNTech COVID-19 pediatric vaccine formulation, and pending a recommendation from the Centers for Disease Control and Prevention (CDC), the Ohio Department of Health (ODH) is announcing that vaccine providers across the state can begin vaccinating children ages 5 to 11 years old as soon as the CDC makes its recommendation.
Today is a day that many children and numerous adults parents, guardians, grandparents, aunts, uncles, pediatricians, teachers, and coaches have long awaited, said Ohio Department of Health Director Bruce Vanderhoff, MD, MBA. The authorization of this COVID-19 vaccine for younger Ohioans is yet another crucial turning point in this pandemic, allowing us to better protect young children from severe complications from COVID-19. This deadly virus has killed more than 24,000 Ohioans, and has caused nearly 206,000 pediatric infections among those ages 17 and younger.
While children are less likely than adults to get severely ill from COVID-19, they most certainly can, and do, become ill. As of Nov. 1, more than 2,000 Ohio children under 18 had been hospitalized with COVID-19, and 15 had died.
Just like adults, when children become sick from COVID-19, they can spread it to others and suffer severe health outcomes, or even death, explained Dr. Vanderhoff. When more people are vaccinated, it lessens the opportunity for dangerous variants to take hold, helping us to get control of this pandemic.
The Pfizer COVID-19 vaccine pediatric formulation is a smaller 10 microgram dose compared with the dose of 30 micrograms used in adults and adolescents 12 and older. It is arriving in Ohio on a staggered schedule over the coming days. Providers across the state, including local health departments, pediatricians, family physicians,community health centers, adult andchildrens hospitals, and pharmacies, are receiving shipments and will be scheduling appointments or accepting walk-ins. As the shipments arrive and following the CDCs recommendation, providers can begin to administer the vaccine.Ohioans are encouraged to call their provider for more information or visitgettheshot.coronavirus.ohio.govor call 1-833-4-ASK-ODH (1-833-427-5634) to locate a provider or make an appointment.
There are an estimated 997,570 Ohioans ages 5 to 11 years old, bringing the total of Ohioans eligible to be vaccinated based on age to 10,998,272, approximately 94% of the states population.
Ohio Department of Health (ODH) Director Bruce Vanderhoff, MD will hold a press conference with pediatric medical experts about the COVID-19 vaccines for children between the ages of 5 and 11 years old.
Press Conference
WHO: Bruce Vanderhoff, MD, Director, Ohio Department of HealthPatty Manning-Courtney, MD, Pediatrician, Chief of Staff, Cincinnati Childrens Hospital Medical CenterMichael Forbes, MD, Pediatric Intensive Care Specialist, Akron Childrens HospitalMichele Dritz, MD, Pediatrician, Cornerstone Pediatrics; Delegate at Large, American Academy of Pediatrics, Ohio Chapter
WHEN: Wednesday, Nov. 3, 10 a.m.
LIVESTREAM: Watch a livestream on YouTube at https://youtu.be/54iWhEvwLyo
MEDIA ACCESS: Media ONLY may join via Zoom. All guests who are not members of the media planning to ask questions or record should watch on YouTube using the link above.
MEDIA LINK:https://us02web.zoom.us/j/83010933139?pwd=ZE5iSFdZVjRjbXRFZVlucS9sVzdpUT09
Meeting ID: 830 1093 3139Passcode: 687830One tap mobile
+19292056099,,83010933139#,,,,*687830# US (New York)+13017158592,,83010933139#,,,,*687830# US (Washington DC)
COVID-19 vaccines are widely available throughout the state. Many providers offer walk-in appointments, or Ohioans can schedule a vaccination appointment at gettheshot.coronavirus.ohio.gov. Ohioans who want to learn more about the safety, efficacy, and side effects of COVID-19 vaccines should talk to their doctor, nurse, or pharmacist, or visit coronavirus.ohio.gov/vaccine.
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LEXINGTON, Ky. (LEX 18) 11-year-old Wyatt became one of the first Kentuckians in his age group to get vaccinated. He and his siblings each got their first dose at Commonwealth Pediatrics Wednesday morning.
They are among the 28 million kids in America who are now eligible for Pfizer's two-dose COVID-19 vaccine, marking a major milestone in the fight against COVID-19.
"It didn't even hurt!," said Wyatt after receiving his first dose.
LEX 18
The pediatric shots are different from the ones adults and older kids get. They're one third of the dose, and the vials are orange instead of purple, to help prevent any confusion.
What's inside the vial is perhaps the most important.
Doctor Beth Hawse says these vaccines mean more protection for kids, and eventually, a return to normal.
"It's fun to watch the kids come in, I've never seen kids want a vaccine. And I hope I never do again, I hope we never go through this again. But it's interesting how much they understand, and they want to get back to normal. So it's a really good day," said Dr. Hawse.
Elizabeth Hatton feels the same way. She's seen the impacts of COVID-19 firsthand as a physician assistant at Georgetown Community Hospital.
"I'm also a mom. I have a 7 and 10-year-old who've had their lives pretty significantly impacted over the last year and a half or so," said Hatton. "It's just such a gift to be protected and I don't have to worry about that as a mom."
She says her sons will hopefully get their first shot within the next week and join other vaccinated kids like Wyatt and his siblings.
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CENTRAL NEW YORK, N.Y. (WSYR-TV) On Tuesday, a CDC advisory panel voted unanimously to recommend the Pfizer vaccine to children ages 5 to 11. The FDA already cleared the shots, which deliver about one-third of the vaccine given to adults.
The CDC recommendation went to CDC Director Dr. Rochelle Walensky who gave her approval. In New York State, the health department still has to sign off.
NewsChannel 9s Nicole Sommavilla has been reaching out to local doctors and pharmacies to find out where parents might be able to get their kids vaccinated.
Here are the responses from the pediatricians she spoke with:
Heres how pharmacies are shaking out:
Part of the statement from Kinney Drugs reads:
Kinney Drugs is proactively working on protocols to ensure a vaccination experience that is as safe, comfortable, and convenient as possible for these young patients and their families. When Kinney Drugs protocols are complete and when appointments are opened, Kinney Drugs will alert the public as quickly and clearly as possible.
Before the vaccine can be administered to children in New York, the state department of health must also provide official program guidance.
RIVIERA MAYA, Mexico Beginning Nov. 8, PGA Tour players and caddies who are not U.S. nationals will be required to be vaccinated for COVID-19 in order to enter the United States.
The tour alerted its membership of the CDC's new policy in the informational "Green Sheet" it sends to players and caddies each week, a copy of which was viewed by Golf Digest. The updated regulations also require non-U.S. nationals to receive a negative COVID-19 test within three days of traveling to the U.S.
Unvaccinated Americans will still be able to enter the country but must provide a negative COVID-19 test within three days of travel.
Vaccinations became an issue at last week's Bermuda Championship, which was not able to fill its 132-man field in part because of the island nation's vaccine requirement. Had this week's World Wide Technology Championship at Mayakoba taken place one week later, every non-U.S. national player and caddie in the field would be required to be vaccinated in order to return to the United States and resume playing the PGA Tour.
The PGA Tour stopped testing fully vaccinated players in April and ceased its on-site testing program entirely in July. According to Golf Channel, 83 percent of the PGA Tour's players, caddies and essential staff are fully vaccinated.
Nov 4 (Reuters) - Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by U.S.-based Merck (MRK.N) and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, molnupiravir, for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.
It will be administered as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, the regulator said, citing clinical data.
The green light is the first for an oral antiviral treatment for COVID-19 and the first for a COVID-19 drug that will be administered widely in the community. U.S. advisers will meet this month to vote on whether molnupiravir should be authorized. read more
Treatments to tackle the pandemic, which has killed more than 5.2 million people worldwide, have so far focused mainly on vaccines. Other options, including Gilead's (GILD.O) infused antiviral remdesivir and generic steroid dexamethasone, are generally only given after a patient has been hospitalised.
Merck's Molnupiravir has been closely watched since data last month showed it could halve the chances of dying or being hospitalised for those most at risk of developing severe COVID-19 when given early in the illness. read more
Molnupiravir, which will be branded as Lagevrio in Britain, is designed to introduce errors into the genetic code of the coronavirus that causes COVID-19 and is taken twice a day for five days.
Professor Stephen Powis, national medical director for the National Health Service (NHS) in England, said the drug would be administered to patients at higher risk of complications as Britain heads into one of the most challenging winters ever.
A wider rollout will follow if it is clinically and cost effective in reducing hospitalisations and death, he added.
"We are now working across government and the NHS to urgently get this treatment to patients initially through a national study so we can collect more data on how antivirals work in a mostly vaccinated population," UK vaccines minister Maggie Throup told parliament.
PRESSURES
The speedy approval in Britain, which was also the first Western country to approve a COVID-19 vaccine, comes as it struggles to tame soaring infections.
Britain has about 40,000 daily cases of COVID-19, according to the latest seven-day average. That is second only to the roughly 74,000 a day in the United States, which has five times more people, and has fuelled criticism of the government's decision to abandon most pandemic-related restrictions
Data released on Wednesday night showed COVID-19 prevalence in England hit its highest level on record last month, led by a high numbers of cases in children and a surge in the south-west of the country. read more
Pressure is growing on the government to implement its "Plan B" aimed at protecting the NHS from unsustainable demands, involving mask mandates, vaccine passes and work-from-home orders.
Many other big economies, including Germany, France and Israel, have either retained some basic COVID-19 measures like mask mandates or reintroduced them in response to rising cases.
The UK government has said its focus remains on administering vaccine boosters and inoculating 12 to 15-year-olds.
"With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data (on molnupiravir)," MHRA chief June Raine said in a statement.
Last month, Britain agreed a deal with Merck to secure 480,000 courses of molnupiravir.
Professor Penny Ward, an independent pharmaceutical physician, welcomed the approval, but said the NHS needed to outline its plans for rollout and cautioned that supplies were likely to be tight given the strong global demand.
"Comments made by Mr Javid today suggest that it may be made available via a clinical trial, presumably to investigate its effectiveness in vaccinated patients with breakthrough infections, as the original study incorporated unvaccinated adults," she said.
If given to everyone becoming unwell, the nearly half a million courses would not last very long given the more than 40,000 current daily case rate, she said.
TREATMENT RACE
In a separate statement, Merck said it expected to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.
The U.S. based drugmaker's shares were up 2.1% at $90.54 before the market open.
Pfizer (PFE.N) and Roche (ROG.S) are also racing to develop easy-to-administer antiviral pills for COVID-19. Pfizer last month began a large study of its oral antiviral drug for the prevention of COVID-19 in people exposed to the coronavirus.
Merck's molnupiravir is also being studied in a late-stage trial for preventing infection.
Viral sequencing done so far has shown molnupiravir is effective against all variants of the coronavirus, Merck has said, including the more-infectious Delta, which is responsible for the worldwide surge in hospitalisations and deaths recently.
While it is not yet clear when Merck will deliver doses to Britain, the company has said it is committed to providing timely access to its drug globally with plans for tiered pricing aligned with a country's ability to pay.
Merck is also in talks with generic drugmakers about expanding manufacturing licences to build supply of the treatment.
Antibody cocktails like those from Regeneron (REGN.O) and Eli Lilly (LLY.N) have also been approved for non-hospitalised COVID-19 patients, but have to be given intravenously.
Reporting by Pushkala Aripaka in Bengaluru and Josephine Mason in London; additional reporting by Kate Holton;Editing by Anil D'Silva and Mark Potter
Our Standards: The Thomson Reuters Trust Principles.
