The drugmaker Moderna said on Wednesday that it would soon begin testing its coronavirus vaccine in children ages 12 through 17. The study, listed Wednesday on the website clinicaltrials.gov, is to include 3,000 children, with half receiving two shots of vaccine four weeks apart, and half getting placebo shots of salt water.
But the posting says the study is not yet recruiting, and Colleen Hussey, a spokeswoman for Moderna, said it was not certain when the testing sites would be listed or start accepting volunteers. A link on the website to test centers is not yet working, and Ms. Hussey said she was not sure when it would become active.
Moderna announced on Monday that data from its study in 30,000 adults had found its vaccine to be 94.1 percent effective, and that it had applied to the Food and Drug Administration for emergency authorization to begin vaccinating adults. If approval is granted, certain groups of high-risk adults, including people in nursing homes, could receive shots late in December.
But no vaccine can be widely given to children until it has been tested in them. Vaccines meant for both adults and children are generally tested first in adults to help make sure they are safe for pediatric trials.
Modernas vaccine has not yet been studied in children or pregnant women. In the new clinical trial in adolescents, girls past puberty will be tested before each injection to make sure they are not pregnant.
Everyone anticipates that when we test this first in adolescents, then older children, then the real small kids, that the Covid vaccine will work, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University and an adviser on vaccines to the Centers for Disease Control and Prevention.
With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:
But children have more active immune systems than adults, and may have stronger reactions, including more fever, muscle and joint aches, and fatigue, Dr. Schaffner said.
They may be more out of sorts than adults for a day or two, he said. You really do want to know, if its given in adolescents, what can parents expect? You really want to be able to tell them clearly how you might feel for 24 or 48 hours after you receive the vaccine. And obviously, we really want to be able to tell parents it works.
If a child had intense side effects and parents were not prepared for it, they might be reluctant to go back for the second shot, Dr. Schaffner said.
Dr. Paul A. Offit, a vaccine expert at Childrens Hospital of Philadelphia, said that vaccines for the most part work equally well in children and adults. Occasionally, as with the hepatitis B vaccine, different doses are required, he said. Moderna will study the same dose in children that it has tested in adults.
Pfizer began testing its coronavirus vaccine in children as young as 12 in October. A large clinical trial found its vaccine to be 95 percent effective in adults, and the company has requested emergency authorization from the F.D.A. Britain approved the Pfizer vaccine for adults on Wednesday, the first country to do so.
AstraZeneca has also tested its vaccine in children, but not in the United States.
As vaccine studies have moved forward, rumors have spread on social media, particularly among people who oppose vaccines in general, that President-elect Joseph R. Biden Jr. plans to require vaccination for everyone, including children. His team has denied those claims, and Mr. Biden has said that he will rely on scientists advice for the best way to end the pandemic.
UC Davis is among seven California hospitals to receive a portion of California's first 327,000 allotted doses. In a tweet, UC Davis Health said the shipment was delivered by FedEx and will be stored in dry ice. The vaccines are on their way to a UC Davis' ultra-cold storage freezer, then will soon be administered to frontline workers in the Sacramento region.
The first in line are those who work in the emergency department, which includes staff who clean rooms, food service workers, reception staff who greet patients, and those who provide direct patient care such as doctors, nurses, respiratory therapists and more.
As of Tuesday morning, the Greater Sacramento Region sits at 14.8% ICU bed capacity as rising coronavirus cases statewide are being linked to Thanksgiving gatherings. The region was put under a stay-at-home order on December 10. The stay-at-home will continue for a minimum of three weeks despite the positive trend.
Hospital leaders say the plan is start vaccinating staff within an hour of vaccine delivery as early as Monday, likely Tuesday.
Carolyn Bauer said she wasnt afraid when she decided to take part in a COVID-19 vaccine trial earlier this year. In fact, she thought it was just common sense.
Im a very healthy individual, and someone has to do this, Bauer said. To me, I didnt realize how big a deal some people thought that was.
I was like, Is there still room for me?'
Bauer, 55,has been encouraging friends, family and colleagues to get the vaccine when they get the chance.
I would have opted the whole family into the trial if i could have, said Bauer, a Transportation Security Administration agent at San Jose International Airport.The more participants they have, the better data theyre going to get. I wanted to do whatever I could.
Bauer is one of some 44,000 people worldwideparticipatingin the phase 3 trial for the vaccine developed by biotech companiesPfizer and BioNTech. The early research has indicated the vaccine is about 95% effective in protecting people from contracting COVID-19.
Although the trial is still ongoing, the U.S. Food and Drug Administration approved the Pfizer-BioNTech vaccine for emergency use Dec. 11.Santa Clara County received its first 5,850 dosesDec. 15, part of the initial 17,550 doses stateofficials allocated to the county.
Dr. Marty Fenstersheib, COVID-19 testing officer for Santa Clara County, said the county will receive all of its first round of Pfizer doses by the end of this week. Those doses willgo to acute care facilitiesand skilled nursing staff and residents.
There are about 75,000 acute care hospital workers in Santa Clara County, so with this first round of vaccines doses, only 10% to 12% of these workers will get vaccinated. Health officials expect the general public wont have access to COVID-19 vaccines for several months.
State and federal officials are alreadyworking on setting priorities for the order in which people will get the coronavirus vaccines; county health officials plan tofollow those guidelines.County officialsexpect to soon receive additional information from the state about the next shipments of vaccines coming into the county, but did not provide a timeline. Theyll also soon receive and share information about future distribution and requirements.
Do this for everyone
When she enrolled in the trial, Bauer received a 22-page packet full of information about the vaccine, along with numerous consent forms and a copy of the human-research bill of rights. Under the terms of the trial, she had the freedom to decide on her own whether to take part in it at all, is allowed to drop out at any point for any reason, and is entitled to have answered any questions she hasabout her treatment.
Along with agreeing to take two doses of the vaccine, all research subjects agreed to fill out a survey at the end of every week that asks whether theyve had any symptoms of COVID-19. As part of her participation in the trial, Bauer received $119 initially and is paid $5 per week eachtime she fills out the survey.But she didnt do it for the money.
I didnt think it was a big deal, I didnt know they even pay you anything, Bauer said. If youre a healthy person you should do this for everyone.
Researchers plan to monitor studyparticipants for more than two years after their initial dose.
After Bauer joined the trial, she learned that researchers were looking for teenagers to participate also. So, she encouraged herdaughter, Savannah Bauer, to take part too. At first, Savannah, who just turned 17 this month, didnt want to do it.She wasnt excited about the prospect of having toendureseveral uncomfortable nasal-swab COVID-19 tests.
After going through the initial screening, however, Savannah changed her mind.
Im happy that I got to be part of this study, because I know that the information theyre getting (from my participation) it could help other people, Savannah Bauer said. Just taking the vaccine, even if I wasnt getting paid theres this whole global pandemic and this could be something to help it go away and get back to normal.
It was like a bruise
Both Carolyn and Savannah both felt somemild soreness in theirarms where they received theirinjections. But that was the extent of their symptoms.
It was like a bruise. It didnt hurt unless someone touched it, Carolyn Bauer said It hurt (for) like three days for that area.
Currently, the Pfizer vaccine requires a follow-up shot about 21 days after the first dose. An alternate vaccine developed byModerna likewise requires two doses, with the second recommended to be givenabout 28 days after the first.The FDA is expected to approve Modernas vaccine for emergency useas soonas the end of thisweek.
Butpeople shouldnt let down their guards just because the vaccines have started to arrive, Fenstersheib warned.
Testing remains essential in stopping the spread of the virus, Fenstersheib said. We continue to urge essential workers to get tested at least monthly its the only way to determine if someone is infected.
And everyone still needs to wear masks, maintainsocially distancingand refrain from gathering with people outside their households, he said.
We are hoping these vaccines will eventually spell the end of this pandemic, Fenstersheib said. Lets all stay safe and be patient, however, while we wait to receive the vaccine.
Carolyn Bauer had some advice for people who might be nervous about getting the vaccine.
If anything, you should be getting it for everyone else, Bauer said. Theres no reason if youre healthy that you should not get this.
Contact Madelyn Reese at [emailprotected] and follow her @MadelynGReese.
Hundreds of New Jersey health care workers are receiving their first of two doses of the coronavirus vaccine on Tuesday, 286 days after the first case was reported in the Garden State.
The vaccinations at University Hospital in Newark are underway a day after Gov. Phil Murphy announced 4,805 COVID-19 cases and 25 more deaths. That brings the states totals to 405,448 cases and 17,775 deaths from the virus 15,907 confirmed and 1,868 considered probable fatalities.
Officials said 76,050 doses of the Pfizer vaccine were due in New Jersey on Monday and Tuesday with another 86,000 doses of expected to arrive in the state next week.
About 20,000 from the first batch will go to long-term care facilities with the remaining 54,000 bound for hospitals, officials said.
When the Moderna vaccine is approved, New Jersey can expect to receive approximately 154,000 doses in the first shipment.
There were 3,660 patients in the states 71 hospitals with the coronavirus or a suspected case as of 10 p.m. Monday, an increase of 22 from the previous 24-hour period. There were 727 patients receiving intensive care with 456 on ventilators. Hospitals discharged 291 patients on Monday.
About 10.95% of the 38,861 coronavirus tests administered on Thursday, the most recent day for which data is available, were positive.
CORONAVIRUS RESOURCES: Live map tracker | Newsletter | Homepage
Heres a roundup of the latest coronavirus news in New Jersey and elsewhere:
Murphy uncorks bad news for New Years Eve partying. N.J.s indoor bar, restaurant curfew unlikely to change: Murphy said Monday he doesnt expect to lift New Jerseys curfew on indoor bars and restaurants meant to try and slow the spread of the coronavirus in time for New Years Eve.
Indoor food and alcohol sales are prohibited indoors after 10 p.m. in the state, and counties and municipalities have the option to shutter nonessential businesses as early as 8 p.m. daily. The rules, which Murphy put into effect last month, mean this New Years celebrations wont be held inside neighborhood bar or restaurant.
N.J. fire station shut down after COVID-19 exposures at unauthorized holiday gathering, town says: A fire station in Essex County suspended operations this week after first responders were exposed to COVID-19 during an unauthorized holiday gathering, officials said.
Operations at Fire Station No. 2 in Verona have been temporarily suspended after several members were exposed to coronavirus during a gathering in the building, township manager Matthew Cavallo said in a statement.
N.J. urgent cares temporarily closing to send staff to hospitals amid coronavirus surge: Inspira Health is temporarily closing five of its 11 urgent care centers for two months or possibly longer in an effort to redeploy its staff to three hospitals and other medical facilities in the wake of the COVID-19 pandemic response, a company spokesman said Monday.
The urgent care facilities in Glassboro, Somerdale and Woolwich closed at 8 p.m. Sunday. Facilities in Haddon Township and Mantua closed earlier this month.
You could be killing your parents, grandparents by spreading COVID-19, Murphy tells young N.J. residents: Murphy had a morbid message for New Jerseys youth Monday: You may be killing older members of your family by spreading the coronavirus.
Murphy warned that even as the Garden State prepares for its first COVID-19 vaccinations Tuesday, New Jersey will continue to see large numbers of cases, hospitalizations, and deaths over the next few weeks as the state continues to deal with a second wave of the pandemic. He said residents cannot let our guard down when it comes to precautions like wearing masks, social distancing, and following restrictions.
78% of those infected with coronavirus refuse to help with contact tracing in N.J.: The number of people in New Jersey who refuse to cooperate with coronavirus contact tracers is hitting new heights.
Seventy-eight percent of people who were contacted by the states more than 3,300 tracers last week wouldnt work with them, Murphy said Monday. Its up from 74% of people who refused the prior week.
Nearly half of N.J.s MVC agencies closed because workers have COVID-19: New Jersey drivers who had to go to a state Motor Vehicle Commission agency found 16 agencies were closed Monday morning, with the Somerville agency the latest to be closed due to an employee testing positive for the coronavirus in each facility.
The latest closures means close to 50% of the states 39 agencies are closed.
The Somerville Vehicle Center closed Monday due to an employee testing positive for COVID-19, and will reopen Saturday, Dec. 26. That employee was last in the agency on Friday.
Coronavirus vaccine scams a concern as doses begin to arrive in N.J., Murphy says: Federal and state officials have said repeatedly thatthe first doseswill be administered tohealth care workers,andnursing home residentsand staff will be next.
While the general population awaits vaccinations later in the winter and into the spring, law enforcement and government agencies are warning people not to fall for fraud involving fake vaccines or related schemes.
U.S. cases: At least 300,494 of the estimated 16,520,408 million to test positive for the coronavirus in the U.S. have died as of 8 a.m. Tuesday, according to the Center for Systems Science and Engineering at Johns Hopkins University.
Worldwide cases: As of 8 a.m. Tuesday, the coronavirus has led to at least 1,623,864 million deaths in 192 counties, according to the center. More than 72.9 million have been infected since the outbreak started in December 2019. At least 41.3 million have recovered.
NJ Advance Media staff writers Anthony G. Attrino, Matt Arco, Bill Duhart, Brent Johnson and Karin Price Mueller contributed to this report.
Thank you for relying on us to provide the journalism you can trust. Please consider supporting NJ.com with a subscription.
ExploreDeWine calls press conference to address coronavirus
Ohio State University Wexner Medical Center in Columbus and UC Health in Cincinnati were the first two hospitals in the state to receive and administer the vaccine on Monday morning.
Patterson said the health district has gotten a ton, of calls from residents wanting to be added to the waitlist, for the vaccine when it becomes available to the general public.
There, unfortunately, will not be vaccines available for the general public until after the first of the year, Patterson said.
And when vaccines are ready for the general public, the health district wont have a waiting list, Patterson said. Instead, vaccines will be on a first-come-first-serve basis.
There wont be a put my name on the waiting list because I want it. Theres just no way for us to manage that list, Patterson said. When we have it available, we will announce it and there will be either an online link or a phone number where people can call to schedule an appointment for their vaccine.
As of now, vaccine roll-out to all county residents will be a partnership between the health district and the large chain pharmacies, Patterson said.
Most likely it will be local health district, but eventually when there is plenty of vaccine, when supply exceeds demand, then I believe it will be moving into retail pharmacies where everyone can go get a shot whenever they want to, Patterson said.
Patterson said while Clark County and the state likely have a couple more months of keeping our guard up, meaning residents will continue to be asked to wear a mask, social distance and stay away for people outside of their households the rollout of the vaccine is extremely exciting.
We can finally see that light at the end of the tunnel. That light maybe six months off to be clearly out of the tunnel, but every vaccine we give gets us one step closer to getting out of the tunnel, Patterson said. Thats exciting and we need a little positive excitement.
Clark County had 7,547 cases, 182 deaths and five probable deaths of the coronavirus as of Monday, according to ODH. Champaign County had 1,516 cases, eight deaths and four probable deaths.
Between Sunday and Monday, the state recorded 7,875 new cases and 59 new deaths, according to ODH. It was the first time since Dec. 6 that the state dropped under 8,000 daily cases. Last week, the state reported more than 10,000 cases for five straight days.
In total, Ohio reported 570,602 cases and 7,551 deaths on Monday, according to ODH.
The majority of the doses of COVID-19 antibody drugs sent to states have not been used, Moncef Slaoui, head of Operation Warp Speed, the US governments coronavirus vaccine effort, told CNBC. Around 65,000 doses of the drugs, which can help protect people at high risk of severe COVID-19 from developing serious cases of the disease, go out each week. Only 5 to 20 percent end up going to patients.
Its disappointing, Slaoui told CNBC, because the drugs could help keep COVID-19 patients out of the hospital.
Doses are going unused because administering them is complicated. Ongoing surges in COVID-19 cases across the country mean states dont have the resources to sort through those logistics. The Utah Department of Health told The Verge in November that the state had to focus on keeping hospitals afloat, and couldnt devote the time to organizing distribution of the antibody drugs.
Despite the thousands of unused doses, the antibody drugs, made by the pharmaceutical companies Regeneron and Eli Lilly, are in limited supply. Each state gets a set amount each week based on the number of COVID-19 cases its reporting each week. Then, the state has to decide how to divvy it up between hospitals. Its not a readily available resource, so doctors arent relying on it as a standard treatment.
Another challenge is that the antibody drugs have to be given to patients soon after they contract COVID-19. Timing is everything. If patients arent getting tested or dont get test results back within a short window after they fall ill, they cant benefit from the drug. Even if they do get diagnosed with COVID-19 quickly at a testing site, they may not start to feel seriously ill or call a doctor until theyre outside that window. Without that contact, they might not know about or be offered the drug.
In addition, the drug has to be given intravenously so patients who are in the early, most contagious stages of their disease have to go to a hospital or outpatient facility where they will interact with nurses and doctors. States and health care organizations have to set up safe places for patients to receive the treatment.
Slaoui told CNBC that Operation Warp Speed may be able to help states work through those logistics. But for now, theyre still a barrier stopping thousands from receiving treatment for COVID-19.
CHICAGO (CBS) Thousands of COVID-19 vaccines arrived in a secret warehouse in the Chicago area on Monday, and they will soon start going into peoples arms.
CBS News Medical Contributor Dr. David Agus joined CBS 2s Marie Saavedra on Monday with some useful information about the vaccine. Saavedra began by asking Agus when someone will become immune after receiving the vaccine.
So the data we have now is that its one week after the second shot. Remember, with the Pfizer vaccine, the second shot is at Day 21, and so a week later, you become immune, Agus said.
So far, the Pfizer vaccine is the only one that has been approved for emergency use. But others are on deck.
With the Moderna shot, it is Day 28 (for the second shot) a week later, you are immune, Agus said. But you can still transmit the virus dont get me wrong. You still need to wear a mask after your vaccine until the numbers fall in the country.
Agus said he expects people will have a choice as to which vaccine they receive, but both the Pfizer vaccine and the other two on deck soon to be approved are safe and work well.
There is no question you will have a choice as more are approved. The hope is Moderna is approved this weekend, and AstraZeneca a week or two thereafter. And so youll see that when your number is called when your particular group is going to be vaccinated you can go to CVS and get the Moderna, or you can go to a hospital and get a particular the Pfizer vaccine. It is your choice, he said. I will tell you that they all are fantastic. All three of them block hospitalization. All three of them are remarkably safe.
Agus said he himself will take the first vaccine that will be available to him because the sooner one gets a vaccine, the sooner someone can prevent serious illness and prevent spreading the virus to others they care for.
Many have expressed concern that the vaccines might have been rushed. Earlier in the pandemic, others including New York Times science and health reporter Donald G. McNeil Jr. noted that the previous record for vaccine development was four years for the mumps vaccine in 1967. Some experts warned that the 12- to 18-month forecast timeline for a vaccine earlier in the pandemic was optimistic and might not be realistic.
But Agus said the fact that a vaccine has arrived in such a short time should not be cause for alarm.
The vaccines werent really rushed. Its just that technology and science got better. So we can develop things much, much more quickly, because over a period of a decade or two, we got good at this, Agus said.
Some have also bandied about conspiracy theories about the vaccine, such that it contains a microchip, could be used to track people, or might alter peoples DNA. Agus noted that those claims are being shared out there on the internet, but are all resolutely false.
There is no microchip. There is no preservative in this vaccine. It is a pure vaccine. And an RNA vaccine cannot change your DNA. It doesnt change fertility or anything of the kind, Agus said. They are safe and they work.
Also From CBS Chicago:
Oregon will become the 49th state Wednesday to start vaccinating its healthcare workers and long-term care facility residents against COVID-19 -- two days after the first shipments arrived early Monday morning.
A group of healthcare workers at Legacy Emanuel Medical Center in North Portland are scheduled to be the first in the state to be injected with the Pfizer-BioNTech vaccine, followed by workers at Oregon Health & Science University in Southwest Portland and Saint Alphonsus Medical Center in Ontario on the Oregon-Idaho border.
Officials at the Oregon Health Authority and Gov. Kate Browns didnt immediately answer questions Tuesday about why Oregons rollout of the vaccine is taking two days to begin and whether that indicates problems within Oregons planning or distribution efforts.
Many states received their first shipments Sunday evening or early Monday morning. Oregons first 975-dose package arrived at 6:45 a.m. Monday.
By Tuesday afternoon, 48 states and the District of Columbia had already started their first injections. Other than Oregon, only Tennessee had not yet inoculated its first resident.
According to The Tennessean, the state received its first doses Monday but put them into storage as a backup supply because state leaders determined there was no equitable way to decide which hospital got the doses first. Gov. Bill Lee said fairness should trump speed, according to the news organization.
In Oregon Wednesday, the governors office will livestream the three hospitals inoculating their first employees with the vaccine. Legacy Health received its first shipments Monday, and OHSU and Saint Alphonsus Medical Center had said their initial shipments were to arrive Tuesday.
The livestream is scheduled to begin at 11 a.m. Wednesday. The public can watch here.
Coronavirus in Oregon: Latest news | Live map tracker |Text alerts | Newsletter
-- Aimee Green; agreen@oregonian.com; @o_aimee
President-elect Joe Biden, here on Monday, says he plans to get vaccinated publicly for the coronavirus. Drew Angerer/Getty Images hide caption
President-elect Joe Biden, here on Monday, says he plans to get vaccinated publicly for the coronavirus.
High-ranking officials, including President-elect Joe Biden and Vice President Pence, are making preparations to get the COVID-19 vaccine, hoping to instill trust and confidence in the vaccine ahead of its widespread distribution as the death toll climbs to new heights.
Biden, who is set to be inaugurated on Jan. 20, said Tuesday it was recommended he get the vaccine "sooner than later" by infectious disease expert Dr. Anthony Fauci, who will become the Democrat's chief medical adviser.
"I want to just make sure we do it by the numbers. When I do it, you'll have notice, and we'll do it publicly," Biden said.
Pence, the outgoing Republican vice president, and his team are discussing options for how and when he will receive a COVID-19 vaccine, an aide to Pence told NPR's Tamara Keith.
President Trump, who has hailed the speed of vaccine development as among his greatest achievements in office, has not publicly said when he plans to be vaccinated.
A 2016 policy on continuity of government protocols provides for executive branch leaders to receive the vaccine quickly, and public health officials have said that public demonstrations of elected leaders getting the vaccine can help Americans hesitant about its safety overcome their fears.
But on Sunday, Trump tweeted: "People working in the White House should receive the vaccine somewhat later in the program, unless specifically necessary. I have asked that this adjustment be made. I am not scheduled to take the vaccine, but look forward to doing so at the appropriate time."
When asked Tuesday about the possible timing of when the president might get the vaccine, White House press secretary Kayleigh McEnany would not commit to when he would do so nor whether he would do it publicly.
She said Trump already has antibodies to the virus because of his treatment for COVID-19 in the fall, and he wanted to make sure that front-line health care workers and people who are vulnerable to the virus get the vaccine first.
McEnany said some senior administration officials would get the vaccine publicly, with announcements on that plan coming in the next few days. She said Trump would take the vaccine when health experts and his White House doctor tell him it's appropriate.
A recent poll by NPR/PBS NewsHour/Marist found that 61% of Americans plan to get vaccinated, up from 49% in September.
The Trump administration made a point of fast-tracking vaccine development, and the Food and Drug Administration last week authorized emergency use of the vaccine developed by Pfizer and BioNTech after endorsement by an advisory panel and clinical trials showing 95% effectiveness. The first vaccinations in the U.S. began Monday.
On Tuesday, the FDA reported that a separate vaccine from drugmaker Moderna was 94% effective overall.
Shawn Hendricks, a Maryland health care worker, always knew she wanted to get vaccinated. Her mother, brother and brother-in-law had already caught the virus, so it hit home personally, but work had also shown her the impact of coronavirus.
Hendricks, nursing director of medicine, was the among the first employees at University of Maryland Medical Center to get vaccinated.
I knew theimpact that the vaccine wouldhave because we need it.I always have felt very stronglythat if we don't widely vaccinate, this pandemicis going to get worse, thenumbers are going to continue toincrease, she said Tuesday.
She says she felt good after getting her shot, and she was observed for a period of time to ensure she had no side effects or adverse effects.
The vaccine is being rolled out while there has been hesitancy in the Black and Latino community to take it. Hendricks says she understands their concern, but having dedicated her life to science and medicine and having done her research, she was willing to get vaccinated.
She added:
Watch:
