Side Effects And Adverse Events
No serious adverse events were reported in early trials of the Novavax vaccine, but more information will be available after the late-stage trial results are published. In Phase 3, adverse events “occurred at low levels and were balanced between vaccine and placebo groups.” according to Novavax.
The most common side effects, according to Novavax:
- Injection site pain and tenderness
- Muscle pain
Injection site pain lasted less than three days and fatigue, headaches, or muscle pain lasted less than two days in the Phase 3 trials.
Some Parents Are Skeptical
Fast or slow, it won’t make a difference for some parents.
“It could come out three years from now and I’m still not going to do it for my kids,” Mariah Bowman said.
Some parents said they’ll make it a family decision. Anthony Cruz plans to talk it through with his 8-year-old son.
“We want to include him in the conversation at the very least and not just mandate ‘yes’ or mandate ‘no,'” he said.
Is A Virus Needed To Develop A Vaccine Against It
With modern molecular tools and technologies, isolating a virus is not required to make a vaccine against it. The genetic sequence can be obtained directly from infected patients and this can be converted into proteins using various platform technologies.
This makes it possible to have vaccines ready for hundreds of pathogens that have not yet infected humans, but have the potential to do so in future.
Shahid Jameel is CEO, Wellcome Trust/DBT India Alliance, Hyderabad and New Delhi
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What Will The Covid
COVID-19 vaccines that are FDA-approved for emergency use will be free to everyone who wants one for the duration of the public health crisis in 2020 and 2021, federal health officials said. That means you dont have to worry about going to an out-of-network provider because no balance billing or surprise billing is allowed.
Cardinal Dolan The Leader Of New Yorks Catholic Church Is In Quarantine
Cardinal Timothy M. Dolan, the leader of the Roman Catholic Archdiocese of New York, was in quarantine on Friday after he interacted last week with a person who later tested positive for the coronavirus, according to a spokesman.
In a statement, the archdiocese said the cardinal has not tested positive, feels fine, and has no symptoms. Joseph Zwilling, a spokesman for the archdiocese, said the cardinal is tested regularly, had tested negative since the interaction, and would be tested again in a few days. He did not specify what kind of tests were used nor the timing of when he cardinal was tested after the interaction.
Tests taken too soon after exposure may return false negative results, because the virus has not yet had time to build up to detectable levels. People are thought to carry the largest quantity of virus around the time their symptoms appear, if they experience symptoms at all.
The cardinals quarantine had not previously been announced by the archdiocese. Mr. Zwilling said the cardinal had been in quarantine since Wednesday but that no announcement had been made because the infected individual had not received the results of their coronavirus test until Thursday.
The cardinal will continue to follow health and safety protocols as instructed by medical professionals, as will others on his staff who also had close contact with this individual, the statement said.
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Vaccine Development: Vaccines Approved For Use And In Clinical Trials
The speed at which the first COVID-19 vaccines were developed was extraordinary. We have previously looked into the history of vaccine development. The measles vaccine was found relatively rapidly: it took only 10 years from the discovery of the pathogen to the development of the first vaccine. But for typhoid it took more than a century, and for some diseases for which weve known the pathogens for more than a century we still havent found an effective vaccine.
The development of a vaccine against COVID-19 has been much faster than the development of any other vaccine. Within less than a year several successful vaccines have already been announced and were approved for use in some countries.
The hope is that even more manufacturers develop vaccines for COVID-19. This will be important because eventually a very large share of the world population needs to receive a COVID-19 vaccine.
We are on the way to several vaccines against COVID-19 vaccine trackers monitor the progress:
Several institutions maintain websites on which they list COVID-19 candidate vaccines that are currently being developed:
|Oxford/AstraZeneca, Sinopharm/Beijing, Sinovac, Sputnik V|
Johnson & Johnsons Vaccine Offers Strong Protection But Fuels Concern About Variants
Johnson & Johnson said on Friday that its one-dose coronavirus vaccine provided strong protection against Covid-19, offering the United States a third powerful tool in a race against a worldwide rise in virus mutations.
But the results came with a significant cautionary note: The vaccines efficacy rate dropped from 72 percent in the United States to 57 percent in South Africa, where a highly contagious variant is driving most cases. Studies suggest that this variant also blunts the effectiveness of Covid vaccines made by Pfizer-BioNTech, Moderna and Novavax.
The variant has spread to at least 31 countries, including two cases documented in the United States this week.
Johnson & Johnson said it planned to apply for emergency authorization of its vaccine from the Food and Drug Administration as soon as next week, putting it on track to receive clearance later in February.
This is the pandemic vaccine that can make a difference with a single dose, said Dr. Paul Stoffels, the companys chief scientific officer.
The companys announcement comes as the Biden administration is pushing to immunize Americans faster even as vaccine supplies tighten. White House officials have been counting on Johnson & Johnsons vaccine to ease the shortfall. But the company may have as few as seven million doses ready when the vaccine is authorized, according to federal health officials familiar with its production, and no more than 32 million doses by early April.
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When Will A Coronavirus Vaccine Be Ready
The Russian vaccine still has to complete final trials, raising concerns among some experts at the speed of its approval
Around the world, politicians, drugmakers and regulators offer contradictory outlooks on when a COVID-19 vaccine will be ready. Much depends on what ‘ready’ means and for what group of people. Some key questions around the timeline are:
WHEN WILL WE KNOW A VACCINE WORKS?
More than half a dozen drugmakers around the world are conducting advanced clinical trials, each with tens of thousands of participants, and several expect to know if their COVID-19 vaccines work and are safe by the end of this year.
The most optimistic timeline comes from AstraZeneca Plc , which is running a study in Britain that it says could be completed as early as August.
Dr. Anthony Fauci, the top U.S. infectious diseases expert, told Reuters last week that a trial by Moderna Inc could produce decisive results by November or December. Others will come later, some much later.
Some experts are skeptical that the trials, which must study potential side effects on different types of people, can be completed that quickly. Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine in Texas, says that collecting enough data to prove a vaccine is safe for the world could take until mid-2021.
WHEN WILL THE FIRST SHOTS BE READY?
- Coronavirus in Israel: Only four ‘green’ countries let Israelis enter, Foreign Ministry official says
WHEN CAN I GET IT?
It Seems Likely That The Earliest We Could Have A Covid
Pfizer says they anticipate sharing results and seeking authorization for their vaccine in ages 5 to 11 as early as September or October. Their COVID-19 vaccine is still the only one authorized for ages 12 to 17 in the U.S.
Moderna has talked about a similar timeline.
Once either company shares safety results and files for emergency use authorization, it could take weeks or months for the FDA to review the information and make a decision.
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Could Schools Require Children To Be Vaccinated
The Pfizer vaccine is authorized for children ages 12 to 18 and shot mandates to attend school currently vary by state.
The board of the Los Angeles Unified School District which oversees the second-largest public school system in the country voted to require students age 12 and up to be fully vaccinated. Those who take part in sports and other extracurricular activities should have taken both shots by the end of October and all other students by Dec. 19. New York Citys school system, the nations largest, has only mandated vaccinations for 20,000 student-athletes in certain sports considered at high risk of spreading the virus.
While some districts mull over COVID-19 vaccine mandates, multiple states have banned schools from requiring vaccines.
Denver has a strict vaccine mandate for teachers, plus masks: It’s keeping kids in school.
Health experts say its too soon to speculate if schools will mandate COVID-19 shots after authorization or approval, but vaccines in schools have helped eradicate some diseases in the U.S. like smallpox and polio.
Its to prevent disease in children themselves and prevent outbreaks in communities and those school requirements have been long-standing for many decades and theyve led to very successful control of vaccine-preventable diseases, OLeary said.
Adaptive Design For The Solidarity Trial
A clinical trial design in progress may be modified as an “adaptive design” if accumulating data in the trial provide early insights about positive or negative efficacy of the treatment. The WHO Solidarity trial of multiple vaccines in clinical studies during 2020, will apply adaptive design to rapidly alter trial parameters across all study sites as results emerge. Candidate vaccines may be added to the Solidarity trial as they become available if priority criteria are met, while vaccine candidates showing poor evidence of safety or efficacy compared to placebo or other vaccines will be dropped from the international trial.
Adaptive designs within ongoing Phase IIIII clinical trials on candidate vaccines may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, avoiding duplication of research efforts, and enhancing coordination of design changes for the Solidarity trial across its international locations.
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Six Children Infected With Covid
From CNNs Maggie Fox
About six US children were infected with coronavirus for every case diagnosed in September meaning most cases went undetected, a US Centers for Disease Control and Prevention researcher said Tuesday.
CDC estimates show that about 38% of US children ages 5-11 have been infected with coronavirus more than adults, overall, and about the same as among children and teens ages 12 to 17, the CDCs Dr. Jefferson Jones told a meeting of CDC vaccine advisers. But this varies from 11% in some states to 61% in others, he said.
The CDC looked at data taken from people who had blood drawn for a number of reasons not related to Covid-19, but who were tested for antibodies against coronavirus.
And while about half of all infections among adults are going undiagnosed now, many more are being missed among younger children, Jones told the Advisory Committee on Immunization Practices. In September, among children 5 to 11, the CDC estimates 6.2 were infected in September for every case diagnosed.
Infections resulting in mild or no symptoms appear to be much more common in children than adults, Jones told the meeting.
The CDCs ACIP is meeting now to consider a one-third dose of Pfizers vaccine for children ages 5-11 and will vote later Tuesday.
We Have One More Vaccine That Saves The Lives Of Children Cdc Vaccine Adviser Says
From CNN’s Maggie Fox
Vaccine advisers to the US Centers for Disease Control and Prevention spent considerable time Tuesday explaining their votes in support of Pfizers Covid-19 vaccine for children ages 5 to 11, saying its safe and will protect children form an infection that can hurt them.
We have one more vaccine that saves lives of children. And that we should be very confident to deploy it to the maximum to do what it is meant to do without significant concerns of serious adverse effects, said Dr. Sarah Long, a professor of pediatrics at Drexel University College of Medicine in Philadelphia, and one of 14 members of the Advisory Committee on Immunization Practices who voted to recommend the vaccine.
As youve heard, we all have a lot of enthusiasm for this vaccine in this age group, added Dr. Beth Bell, a clinical professor of global health at the University of Washington.
It’s now up to CDC Director Dr. Rochelle Walensky to recommend the vaccine, and she has signaled she will do so. After that, vaccination of the younger children may begin immediately.
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When Will A Covid
Industry experts say a vaccine against the SARS-CoV-2 virus will either be ready this fall, at the end of the year or 18 months from now, depending on the vaccine and how they define ready.
Generally, those experts are talking about emergency use authorizations for targeted populations, such as healthcare workers, first responders and the elderly. Widespread, population-level vaccinations are unlikely to begin before sometime in 2021, Scott Gottlieb, former FDA commissioner, speculated in a CNBC interview.
Normal vaccine development takes 8 to 10 years, Thomas Lingelbach, president and CEO of Valneva SE, said. In principle, developing a new vaccine isnt difficult. The human body creates antibodies to the virus, so drug developers are trying to build antigen that does the same.
SARS-CoV-2 isnt just another virus, though. Its never been seen before and scientists are still learning its fundamentals. Given the potential of the threat, drug developers and regulators are doing everything in their power to expedite safe, efficacious vaccine development.
Pfizer, with its mRNA vaccine BNT162, was a few weeks slower. It dosed its first cohort in Germany at the end of April and the first U.S. patients in Phase I/II trials in the U.S. in May. It predicts commercialization by the end of October and the manufacture of 10 to 20 million doses for emergency use by years end.
Speed may not confer success, of course.
Specifically for vaccines, ACTIV is:
Who Can Get The Novavax Vaccine
Like other COVID-19 vaccine candidates, the Novavax vaccine has been tested in adults aged 18 and up.
The company announced on June 14, 2021, that it completed enrollment of 2,248 adolescents in its Phase 3 trial in adolescents ages 12 to 17. Novavax has not provided updates on trials in younger children.
Information hasn’t been provided yet on concerns for specific groups.
If the vaccine is authorized by the FDA, any doses purchased by the U.S. government will be free to its citizens. While the vaccine itself is free, the facility or agency that offers the vaccine may seek reimbursement for administration costs from heal insurance plans or public health programs. However, no one receiving a vaccine can be charged any fees.
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How Long Does It Take To Develop A Vaccine
It can take years to develop vaccines first in laboratories to show proof-of-concept, then developing a manufacturing process to make stable and a highly pure product to be tested in animals and humans, and finally for the market.
The COVID-19 vaccine has been fast-tracked into humans without prior testing in animals. Still, it may take one to two years for the clinical trials to be over. Since there is no guarantee that the mRNA-1273 vaccine would work, a rich pipeline of over 40 candidates is important.
Guns Trucks And Trips: West Virginia Expands Prizes For Vaccinated Residents
Goepfert says it’ll be a good thing if all these vaccines make it to consumers. But that alone isn’t going to solve the problem of getting people vaccinated.
Why? “Because the vaccines that we have now are just beyond our wildest dreams kind of effective,” he says. “And I’m living in a state right now where it just frustrates me how slow our vaccine uptake is.”
Goepfert lives in Alabama. According to the latest numbers from the Centers for Disease Control and Prevention, only Mississippi has a lower per capita rate of vaccination.
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University Of Michigan Students Are Advised To Stay Home After 14 Cases Of A Coronavirus Variant Were Reported
Fourteen students at the University of Michigan have contracted a highly contagious variant of the coronavirus, leading health authorities to issue a stay-at-home recommendation for students living on and off campus.
Students were advised to not leave their residences until Feb. 7, except to attend classes, seek medical treatment or run essential errands.
The outbreak of the variant, first detected in Britain and known as B.1.1.7, appears to have started with a student who traveled to the United Kingdom over the winter break, according to Susan Ringler-Cerniglia, a spokeswoman for the Washtenaw County Department of Health.
The first case on the universitys campus was identified on Jan. 16 after the student tested positive and notified officials that he or she had traveled to an area where the variant was prevalent. That prompted additional sequencing that identified the student was infected with the variant, Ms. Ringler-Cerniglia said.
Since then an additional 13 students who are positive with the same variant have been identified. One of them had visited a local indoor mall and a grocery store before testing positive, leading authorities to issue a public notice to people who had visited those locations, asking them to seek testing.
Rick Fitzgerald, a spokesman for the university, said that all the infected students were in isolation with mild symptoms.
In other news from around the United States:
Most States Have Opened Vaccines To Older Americans According To A Times Survey
About seven weeks since the United States began rolling out vaccines against the virus, at least 47 states are offering shots to older people, a New York Times survey shows. Thats a significant shift from a few weeks ago when most places were focused on inoculating residents of long-term care facilities and frontline health care workers, and the rollout remains a dizzying, shifting patchwork as states set their own eligibility rules and residents try to keep track.
Many of the expansions follow a federal appeal to prioritize all people 65 and older. More than half of states have since expanded eligibility for those seniors but have had varying degrees of success in delivering the promised shots into arms. As of Friday, states have given out 57 percent of the shots delivered to them so far, and 6.9 percent of the nations population now has at least one shot, according to data from the Centers for Disease Control and Prevention.
This does not mean that right away you will be able to get the vaccine as quickly as you have in the past gotten your flu shot, said Gov. J.B. Pritzker of Illinois, a Democrat, who allowed residents 65 and older statewide to schedule appointments starting this week. He said that 3.2 million of the states 12.6 million residents fall into the group newly eligible for shots, adding, so there will be far greater demand than supply at least in the near term.
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