Report Series: A Primer On Covid
This series of brief reports will shed light on COVID-19 vaccine development, allocation and deployment in the United States and globally. Topics will include ensuring the safety and efficacy of Covid-19 vaccines, principles for vaccine allocation, strategies for deployment and delivery of Covid-19 vaccines, vaccine confidence and demand, and the economics of Covid-19 vaccines.
Do I Need To Give Consent For My Child To Get Vaccinated
Parents generally need to consent to children receiving medical care, including Pfizer’s COVID-19 vaccine. This is especially true for younger children.
However, depending on which state you live in, there may be a legal precedent for teens and other kids to request the vaccine without parental permission.
Tennessee’s vaccine director, Michelle Fiscus, was fired in August, allegedly in part for sending out a memo detailing the state’s “mature minor doctrine,” which explains how minors may seek medical care without the consent of their parents.
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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What Vaccines Does Covax Use
Six vaccines have been given “emergency use authorisation” by the WHO, meaning they can be shared via Covax: AstraZeneca, Pfizer, Janssen, Moderna, Sinopharm and Sinovac.
However, only Pfizer and AstraZeneca doses have been delivered so far.
Moderna has agreed to supply 500 million doses at its “lowest-tiered price”, but most won’t be available until 2022.
What Does Full Fda Approval Of A Covid
Review for full FDA approval is a normal step in the process of making a vaccine available for the public. One of the COVID-19 vaccines has full approval, and the FDA may grant full approval for others in the future.
Full FDA approval takes place when enough data demonstrate that the vaccines are safe and effective for most people who receive them, and when the FDA has had an opportunity to review and approve the whole vaccine manufacturing process and facilities. After many months of studies and more than 165 million people having received a COVID-19 vaccine, the FDA has a lot of information on how safe and effective the COVID-19 vaccines are in protecting people, how well they work to prevent severe coronavirus disease, and how the vaccines are safely and consistently manufactured.
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Evaluation Of The Moderna Covid
The effectiveness and safety data evaluated and analyzed by the FDA for the Moderna COVID-19 Vaccine to support the EUA for these pediatric populations were generated in two ongoing, randomized, blinded, placebo-controlled clinical trials in the United States and Canada which enrolled infants, children and adolescents.
The safety data to support the Moderna COVID-19 Vaccine EUA in individuals 6 months through 17 years of age are as follows:
The most commonly reported side effects in the clinical trial participants for both the 6 through 11 age group and the 12 through 17 age group who received the vaccine include, pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever.
Covax: How Many Covid Vaccines Have The Us And The Other G7 Countries Pledged
The US has pledged to donate 500 million more doses of the Pfizer vaccine to poorer nations from next year – bringing its total commitment to more than one billion.
“To beat the pandemic here, we need to beat it everywhere,” US President Joe Biden told a virtual Covid-19 summit.
The donation will be routed through Covax – the international scheme designed to ensure low-income countries aren’t left behind in the fight against Covid.
It came amid growing warnings over the pace of global vaccinations, and inequity of access.
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Is The Covid Vaccine Safe For Children
The results submitted to the FDA and CDC are still preliminary, both agencies say they are safe and effective.
“There are many processes in place to ensure safety, including oversight from vaccine advisory groups, the FDA, and the vaccine manufacturers,” Dr. Leslie Sude, a pediatrician at the Yale School of Medicine, said in a statement. “We are fortunate to live in a country that has these oversights in place.”
Sude added that children get lower doses of the vaccines than adults but “mount robust antibody responses with no safety concerns.”
Us Throws Out Millions Of Doses Of Covid Vaccine As World Goes Wanting
Figures surged over summer as doses expired and vaccinations flagged amid widespread hesitancy
The United States is wasting millions of Covid-19 vaccine doses even as shortages plague many parts of the world.
At least 15m doses were scrapped in the US between March and September, according to one analysis of CDC data. A separate investigation found 1m doses were discarded in 10 states between December and July.
States continue tossing unused shots. Louisiana has thrown out 224,000 unused doses of the Covid vaccines a rate that has almost tripled since the end of July, even as a deadly fourth wave of the virus gripped the state. Some of the lost doses came from opening and not finishing vials, but more than 20,000 shots simply expired.
The wasted doses represent a small fraction of the number of shots administered in these states in Louisiana, for instance, 4.4m doses have been given out successfully.
But the news comes as millions of people around the world wait for their first doses. Only 1% of the populations of low-income countries had received first shots as of July, compared with more than half of those living in a handful of high-income countries.
Officials are also working with vaccine manufacturers to reduce the number of doses in each vial.
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Covid Vaccines: Emergency Use Authorization Vs Approval
Not every vaccine is granted an emergency use authorization before full approval. The FDA authorized three COVID-19 vaccines to answer an urgent need to protect people from the coronavirus pandemic, which was a public health emergency.
When it was clear in 2020 that COVID-19 was a rapidly spreading, dangerous disease, the FDA worked with vaccine manufacturers, independent laboratories, academic research centers and nonprofit organizations to quickly gather and interpret large amounts of data on the vaccines.
The data showed that the vaccines were very effective in preventing severe COVID-19 and the risks of serious side effects was extremely low. Based on these findings, the FDA granted the EUA so people could be vaccinated earlier in the approval process and be protected from serious effects of COVID-19.
Full approval is granted when, over time, the FDA has amassed even more scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality.
Vaccines Roll Out Slowly For Us Children Younger Than 5
Health workers across the United States began to give Covid-19 vaccinations to children 6 months to 5 years old on Tuesday, another milestone in the coronavirus pandemic that came 18 long months after adults first began to receive injections against the virus.
But the response from parents was notably muted, with little indication of the excitement and long lines that greeted earlier vaccine rollouts.
An April poll showed that less than a fifth of parents of children under 5 were eager to get access to the shot right away. Early adopters in this age group appeared to be outliers.
At 9 a.m., Dayton Childrens Hospital in Ohio became one of the first sites to vaccinate the youngest children, with the three-dose Pfizer-BioNTech vaccine meant for this age group. The Centers for Disease Control and Prevention has also endorsed a second option for young children, a two-dose regimen from Moderna.
Brian Wentzel, 38, brought his 2-year-old son, Bodhi, at 9:15 a.m. The boy clutched a stuffed dog and bravely took the shot in his leg. His mother is a physician at the hospital.
It was important to get him vaccinated, Mr. Wentzel said. It is extremely effective at preventing severe illness.
At a White House news conference on Tuesday afternoon, President Biden
The United States, he continued, is now the first country in the world to offer safe and effective Covid-19 vaccines for children as young as 6 months old.
Jill Cowan contributed to this report.
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How Each State Compares To The National Share Of Fully Vaccinated People
There are many reasons eligible people are not vaccinated. Surveys have indicated that some people are adamant in their refusal of the coronavirus vaccines, while others are open to getting a shot but have been putting it off or want to wait and see before making a decision.
The first group, surveys have shown, tends to be disproportionately white, rural, evangelical Christian and politically conservative. The second group tends to be a more diverse and urban group, including many younger people, Black and Latino Americans, and Democrats.
In April, The New York Times analyzed vaccine records and voter records in every county in the United States and found that both willingness to receive a coronavirus vaccine and actual vaccination rates were lower, on average, in counties where a majority of residents voted to re-elect former President Donald J. Trump in 2020.
When Might Nearly Everyone Be Vaccinated
Some experts have estimated that 90 percent or more of the total population adults and children would need to be fully vaccinated for the country to reach a possibly elusive threshold of protection against the coronavirus known as herd immunity, now that the outbreak is driven by the highly contagious Delta variant.
A number of factors will determine if and when this threshold is met, including the pace at which newly vaccinated people join those who are immune after past infections. But the presence of more transmissible virus variants could complicate that progress. And children, who became eligible for the Pfizer vaccine in late October, may be key to reaching herd immunity, experts say.
The projection below shows the share of the total population that is fully vaccinated based on the current rate of vaccination, and provides a rough indication of when the viruss spread could begin to stall.
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The Pace Of Vaccinations Has Been Steadily Climbing Since The Summer
Based on the seven-day average of people becoming fully vaccinated each day.
But the pace of vaccinations varies across the country. Many states in the South and West, for example, have fully vaccinated a smaller share of their population than in other regions.
On Dec. 9, the C.D.C capped its vaccination rate figures at 95 percent, after acknowledging that it may be overestimating first doses of the vaccine and underestimating booster shots. As a result, even locations that have exceeded that vaccination rate will remain at 95 percent.
The C.D.C. said on its website that the cap helps address potential overestimates of vaccination coverage due to first, second, and booster doses that were not linked. Other possible reasons for overestimation, according to the agency, include census population data that excludes part-time residents or reporting errors.
Early Authorizations In China And Russia
On 24 June 2020, China approved the CanSino vaccine for limited use in the military and two inactivated virus vaccines for emergency use in high-risk occupations. On 11 August 2020, Russia announced the approval of its Sputnik V vaccine for emergency use, though one month later only small amounts of the vaccine had been distributed for use outside of the phase 3 trial. In September, the United Arab Emirates approved emergency use of the Sinopharm BIBP vaccine for healthcare workers, followed by similar emergency use approval from Bahrain in November.
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Who Is Eligible For A Vaccine
The United States has reached a new milestone in its vaccine rollout: children ages 5 to 11 are now eligible for a vaccine, after the F.D.A. authorized use of the Pfizer vaccine for this age group.
In May the F.D.A. had expanded its emergency use authorization of that vaccine for children 12 and older, allowing young adolescents to start getting vaccinated before school started in the fall of 2021.
And in April every state had made those 18 and older eligible for the shots, according to a Times survey. This universal eligibility followed months where states relied on complicated phase-based plans that prioritized certain vulnerable individuals like older Americans, critical workers and those with certain medical conditions. Often, county plans differed from state plans.
When Can My Kid Get A Booster
Most kids 5 and older are currently eligible for a single booster dose of Pfizer’s COVID-19 vaccine at least five months after their second primary dose. Immunocompromised kids are eligible for their first booster at least three months after their last vaccine.
In March, the FDA for children 12 and older with compromised immune systems.
Children’s booster shots are available only at locations where the low-dose Pfizer vaccine for kids is in stock. Call your pediatrician or local health clinic for a recommendation. You can text your ZIP code to 438829 or use this vaccine finder link to find a location near you.
“Vaccination with a primary series among this age group has lagged behind other age groups leaving them vulnerable to serious illness,” Walensky said in a statement in May. “We must continue to increase the number of children who are protected.” A decision has not been made yet about boosters for children under 5.
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Where Can I Get A Covid
All adults in the U.S. are eligible to receive a COVID-19 vaccine, and children 5 years and older are able to receive the Pfizer vaccine. Visit Vaccines.gov to find out where vaccines are in stock near you and schedule an appointment.
You can also text your ZIP code to 438 829 to receive contact information for vaccine providers in your area.
Illustrated guide: What to expect before and after getting a COVID-19 vaccine
Populations used for U.S. state, District of Columbia and Puerto Rico calculations are from the U.S. Census Bureau’s 2019 state population estimates. Populations used for other territory and associated island state calculations are from the World Bank.
The share of distributed doses used in each state or territory is calculated by dividing the number of doses administered in that state or territory by the number of doses distributed to that state or territory. The percent of people vaccinated in each state, territory or county is calculated by dividing the number of residents of that state, territory or county who have been vaccinated by the population of that state, territory or county.
Because of reporting delays and other factors, the CDC data above may differ from that of states’ and territories’ own reports and dashboards. For more information, see the footnotes on the CDC’s website. To see the CDC’s log of changes and corrections to the data, check the historical updates.
Contributing: Mitchell Thorson, Mike Stucka and Shawn Sullivan
Newshow India’s Covid Crisis Is Inflaming Global Vaccine Inequality
The number of doses that went to waste is a small fraction of the more than 438 million doses that were distributed in the country as of Tuesday and the 111.7 million additional doses the U.S. had given to other countries as of Aug. 3.
Demand for vaccines in the U.S. rose in August as cases and hospitalizations surged due to the delta variant. Still, the U.S. wasted at least 3.8 million doses in August alone, the data shows.
States, pharmacies and other vaccine providers also reported at least 4.4 million wasted doses to the CDC in June and 4.7 million in July more than in March, April and May combined.
No state health department came close to the number of doses wasted by pharmacy chains, but four reported over 200,000 wasted doses each. Texas led in reports of vaccine waste by states, with 517,746 wasted doses, North Carolina reported 285,126, Pennsylvania reported 244,214 and Oklahoma reported 226,163.
The Pennsylvania Department of Health released a statement saying, “While we do everything possible to avoid waste, and while we dont want to waste on purpose, we also dont want to miss any vaccination opportunities.”
Representatives for the North Carolina and Oklahoma health departments did not immediately respond to requests for comment. Officials in Oklahoma previously blamed vaccine waste on the need to get vaccines into arms, even if that means throwing away unused doses.
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Us Has Shipped 110 Million Covid
Calling it a major milestone, U.S. President Joe Biden announced on Tuesday that the country has shipped more than 110 million doses of coronavirus vaccine to 65 nations that are among the hardest hit in the world.
“This is more than the donations of all 24 countries that donate any vaccine to other countries, including China and Russia,” Biden said during remarks in the White House East Room.
The president emphasized that Washington is making no demands for its donations of doses.
“And there’s no favoritism and no strings attached. We’re doing this to save lives to end this pandemic,” Biden said.
In response to a question from VOA on whether other high-income countries should follow the lead of the United States, the president replied: “I think those countries that have been able to cover their population and have the ability to provide either dollars and/or vaccines for the 100 or so net-poor nations that need help should do so.”
Biden added that some Group of 7 countries, which made such pledges at their recent summit in England, have followed through.
“We’ve kept the commitment that we would do what we said, which is more than all the rest of the countries combined this far,” the president noted.
Tom Hart, acting chief executive officer of the ONE campaign, a global organization fighting extreme poverty and preventable disease, agreed with Biden’s call for other prosperous countries to do more.