Harris County Judge Lina Hidalgo and Houston Mayor Sylvester Turner pleaded with residents to cancel holiday gatherings this year as COVID numbers continue to rise.
HOUSTON Two days before Christmas, the COVID-19 trends are getting worse in Houston. Leaders in Harris County and Houston are hoping residents do what they can in order to avoid what has happened in other communities across the state.
Local leaders held a news conference Wednesday urging residents to cancel holiday plans in order to slow the spread in the Houston area.
Harris County Judge Lina Hidalgo and Houston Mayor Sylvester Turner both pressed the issue. Both the mayor and the judge referenced rising hospitalization rates and a rising positivity rate that has nearly doubled over the last month.
"We can't sustain a surge in cases beyond what we're at now," Hidalgo said. "All across Texas, communities are entering dangerous territory. We've consistently seen the cases increase, and most worrisome, the ICU population continues to increase. It's a very real possibility that we could end up facing the fate we've avoided thus far."
Multiple national COVID-19 models suggest Houston could be the next hotspot in January. It's why Turner and Hidalgo joined forces Wednesday to plead with the public to cancel and holiday gatherings or parties with anyone outside their immediate household.
"You don't want someone to get sick because you decided to host a holiday party," Hidalgo said.
The numbers are moving in the wrong direction, and although it's manageable now, Turner and Hidalgo said they're worried it won't be for much longer. Local health experts share the same concern.
Since Thanksgiving, contract tracing shows the spread is happening in private gatherings where people let their guard down, not in controlled environments like office settings and school classrooms.
"We've unfortunately seen our positivity rate has doubled in the last two months. If we continue with this trajectory, it will triple by January," Dr. Sherri Onyiego, with the Harris County Health Department, said.
If people ignore the threat, city and county leaders said they have one tool left in their toolbox to try to tame the virus: A curfew.
"I view it as a nuclear option," Turner said. "Once you've done it ... you've done it."
Hidalgo said no curfew will be put in place at this time but the option is still on the table if things get worse. She said the curfew would only be used in a "worst-case scenario."
Turner announced 634 new COVID-19 cases in the city as well as two more deaths related to the virus. The city's positivity rate is at 11.2% and has been rising over the last month or so.
Public testing sites in the city and county will be closed on Christmas Eve and Christmas Day but will reopen Saturday.
Turner and Hidalgo said the vaccine is a step in the right direction. Both the Pfizer and Moderna COVID-19 vaccines have already been rolled out in the Houston area.
Modernas COVID-19 vaccine began arriving Monday at dozens of Houston-area hospitals and clinics. The City of Houston is expected to get at least 6,000 doses of Modernas COVID-19 vaccine this week.
Those doses will be split evenly between the Houston Health Department, the Houston Fire Department and other frontline health workers.
The support operations, the functions that are filled by support personnel, at this moment dont qualify, said HFD Chief Sam Pea during a news conference Monday afternoon. But as soon as the decision is made for the Phase 1 Bravo group to be eligible, then well be prepared to administer those.
Although both vaccines use messenger RNA or mRNA to attack the coronavirus and both require two doses, there are some key differences.
Pfizer's is approved for people ages 16 and older. Moderna's is for people 18 years or older.
Pfizer's must be stored in ultra-cold freezers, around -80 degrees Celsius. Moderna's can last in normal refrigerators for up to 30 days.
According to Dr. Catherine Troisi, an infectious disease epidemiologist at UT Health School of Public Health, the difference is because of the lipids, or fats, that each company used for surrounding the mRNA.
She said Moderna's are more stable, but that Pfizer did not know that when creating their vaccine.
Get whichever vaccine you can," said Dr. Troisi. "They are both equally effective.
Pfizer requires shipment batches of 975 or more. Moderna requires 100 or more.
NASHVILLE, Tenn. (WKRN) The Tennessee Department of Health hasconfirmed additional cases and deaths related to COVID-19 across the state for Wednesday, December 23.
The department reported 7,221 new cases, putting the state at 541,240 total cases. Of the total cases, 481,706 are confirmed and 59,534 are probable.
There are currently 79,274 active COVID-19 cases in the state.
Tennessees seven-day new cases average is currently 8,136 additional cases per day, while the 14-day new cases average is 8,448.
Of the 541,240 cases, 285,985 are female (53%), 250,877 are male (46%), and 4,378 are pending (1%).
TDH confirmed 111 additional deaths, bringing the state up to 6,380 total deaths. Wednesday now stands as the fourth-highest single-day increase of deaths in Tennessee. The state is averaging 77 new deaths per day in December.
Out of the total positive cases, 455,586 are listed as inactive/recovered, an increase of 7,590 in the last 24 hours.
Earlier on Wednesday, the state reported a new record-high 2,934 people are currently hospitalized in Tennessee due to COVID-19. The number of total COVID hospitalizations now sits at 13,970.
Tennessee has processed 5,386,825 tests with 4,845,585 negative results. The percentage of positive cases remains around 10%. Wednesdays update added 29,883 tests to the states total with 17.53% percent positive cases.
Tennessee reported an increase of 1,778 deaths in December so far. The state has seen more deaths in 23 days this month, than during the first six months of the pandemic combined (1,754 deaths Aug. 31).
Tennessees top five single-day death increases have all been this month.
The state has also reported an increase of 166,747 cases this month. The new cases through 23 days is more than the total cases for the first six months of the pandemic (154,933 cases Aug. 31). The top five single-day increases have all fallen within the last ten days.
Vaccine Tracker
On Tuesday, TDH reported 24,236 vaccinations have been given out so far in Tennessee. On the same day, the department announced that soon the state will begin receiving 50,000 Pfizer and 40,000 Moderna vaccines weekly.
Less than two weeks after a COVID-19 vaccine was approved, the Metro Nashville Health Department transformed the East Nashville Explore Community Center into a clinic to administer the shots. The clinic began operations Wednesday with 311 people scheduled to receive the first dose.
Sumner County Mayor Anthony Holt announced the countys mask mandate would be extended once again.
The Executive Order for Sumner County will take effect at the end of the current order at 11:59 p.m. Tuesday, December 29, and will remain in effect until 11:59 p.m. on February 27, 2021, unless sooner canceled or extended.
Governor Bill Lee has announced he has extended the State of Emergency in Tennessee through 11:59 p.m. on February 27, 2021.
Lee delivered a statewide address to Tennesseans Sunday night regarding a surge in COVID-19 cases. Lee announced he is limiting holiday gatherings to no one outside of families immediate households and all public indoor gatherings will be limited to 10 people.
Very strong encouragement for people to limit Christmas parties or New Years parties or New Years dinners or holiday time together by staying with their immediate family members inside their home, said Lee during a call with media on Monday.
Some Tennessee leaders were hoping that the governor would announce a statewide mask mandate during his remarks on Sunday.
A group of Tennessee doctors was also hoping for a statewide mask mandate. I dont know what it will take at this point, I think he made a great step yesterday, limiting gatherings is a huge first step, but that goes hand in hand with a statewide mask mandate, said Dr. Aaron Milstone at Williamson Medical Group with Protect My Care TN Doctors.
The Moderna vaccine has arrived in Tennessee, the Tennessee Department of Health said in a media briefing Monday afternoon. TDH reported the Moderna vaccine arrived in all of Tennessees 95 counties. The 5,000 doses of the Moderna vaccine designated for emergency backup will be released immediately. Tennessee anticipates delivering 115,000 Moderna vaccines throughout the state in the next two weeks.
On Saturday,Governor Lee announced his wife Maria Lee tested positive for COVID-19. The First Lady tested positive for COVID-19 after experiencing mild symptoms of the virus. The governor said he doesnt have any symptoms and tested negative Saturday night. However, as a precaution, he will be quarantining at the Governors Mansion.
On Sunday, the Tennessee Department of Health also held a media briefing on hospital capacity in Tennessee, sayinghospitals wont be able to keep up with another COVID-19 surgelike we saw after the Thanksgiving holiday.
COVID-19 in Nashville
Earlier Wednesday, Metro Public Health Department officials reportedanincrease of 422 COVID-19 cases in Davidson County, bringing the countys total to 63,944.
Members of the Metro Coronavirus Task Forceare urging caution this holiday season, saying the COVID-19 outbreak in Nashville has reached a new peak.
The Nashville Office of Emergency Management and the Metro Public Health Department is asking for volunteers to help with Nashvilles COVID-19 vaccine rollout.
Metro Nashville Public Schools announced the district will start the second semester virtually due to increased COVID-19 cases. The second semester is set to begin on January 7. MNPS will use a risk score based on metrics from the Metro Public Health Department to make decisions on when to return to in-person learning. School officials say that score must be below seven before returning to face-to-face learning.
Stay with News 2 for continuing coverage of the COVID-19 Pandemic.
For Immediate Release: December 18, 2020
Espaol
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day, said FDA Commissioner Stephen M. Hahn, M.D. Through the FDAs open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agencys career staff.
The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential riskssupporting the companys request for the vaccines use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 viruss mRNA that instructs cells in the body to make the viruss distinctive spike protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
Guided by science and data, the agencys career staff determined that the vaccines known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDAs expectations described in our June and October guidance documents have been met, said Peter Marks, M.D., Ph.D., Director of the FDAs Center for Biologics Evaluation and Research. Todays authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained. This achievement is yet another testament to the dedication of FDAs career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19.
FDA Evaluation of Available Safety Data
Moderna COVID-19 Vaccine is administered as a series of two doses, one month apart. The available safety data to support the EUA include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S. These participants, 15,185 of whom received the vaccine and 15,166 of whom received saline placebo, were followed for a median of more than two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.
It is mandatory for ModernaTX, Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Moderna COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the EUA include an analysis of 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine. Among these participants, 14,134 received the vaccine and 14,073 received placebo. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. At the time of the analysis of these 196 COVID-19 cases, none in the vaccine group and 30 in the placebo group were classified as severe. After the analysis of these 196 cases was completed, one severe case in the vaccine group was identified and is awaiting confirmation. At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
The EUA Process
On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.
The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits. If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.
The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Moderna COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.
ModernaTX, Inc. has submitted a pharmacovigilance plan to the FDA to monitor the safety of Moderna COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Moderna COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.
The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).
The EUA for the Moderna COVID-19 Vaccine was issued to ModernaTX, Inc. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Moderna COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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ITHACA, N.Y.Four staff members and one assisted living resident have tested positive for COVID-19 at Bridges Cornell Heights, an assisted living facility on Wyckoff Avenue in Ithaca.
The positive tests have been reported over the last 10 days, and visits were suspended for two weeks on Dec. 14 after post-Thanksgiving holiday testing showed two of the positive tests among staff members. According to Bridges ownership, the resident who tested positive has very mild symptoms, while most of the staff members are doing well also (with one exception, who is "struggling with symptoms" at home but has not been hospitalized).
The facility has been posting updates to its website, particularly after the number of cases among its residents and staff rose recently. Obviously, tensions are high surrounding nursing home COVID cases in Tompkins County as the outbreak continues at Oak Hill Manor nursing home that has claimed the lives of 11 residents there. Thus far, though, no resident has died as a result of the current spate of cases at Bridges.
"We know that the road ahead will not be easy, and a vaccine, no matter how promising and thrilling it is to imagine, will not bring us back to 'normal' any time soon," the facility wrote in its latest update. "However, it will provide one more layer of protection against COVID-19 for the people we love who are at increased risk for severe illness. This is a hope filled and exciting moment as we wait for the call to set up the vaccine clinic the minutes cannot move quickly enough for us."
Bridges owner Elizabeth Classen Ambrose lamented that the facility had seen the jump in positive tests after months of avoiding the coronavirus pandemic penetrating campus.
"We've had really good luck for this entire marathon," Classen Ambrose said. "And right as soon as we're about to cross this finish line and get to the vaccine, we get tagged."
There was one person in a separate rental property who passed away after having tested positive for COVID-19 more than a month ago, Classen Ambrose clarified, though that resident was in very poor health prior to contracting the virus.
Classen Ambrose said that, thanks to Cayuga Health System CEO Dr. Martin Stallone, the resident who tested positive is receiving therapeutic monoclonal antibody infusions, which they qualify for because of their age and relatively mild symptoms. Other residents have been treated with this same method at CMC, she said, and each has had beneficial results.The aforementioned resident who died while renting was on hospice care and thus ineligible to receive the antibody infusions, according to Classen Ambrose.
Vaccinations will likely start at Bridges Cornell Heights soon, as Classen Ambrose said they have been approved to be a COVID-19 vaccination site.
Harrisburg, PA - The Pennsylvania Department of Health today confirmed as of 12:00 a.m., December 23, that there were 9,605 additional positive cases of COVID-19, bringing the statewide total to 581,156.
There are 6,151 individuals hospitalized with COVID-19, double the peak in the spring. Of that number, 1,236 patients are in the intensive care unit with COVID-19. Most of the patients hospitalized are ages 65 or older, and most of the deaths have occurred in patients 65 or older. More data is availablehere.
The trend in the 14-day moving average of number of hospitalized patients per day has increased by nearly 5,600 since the end of September.
Statewide percent positivity for the week of December 11 December 17 stood at 15.8%.
The most accurate daily data is available on the website, with archived data also available.
As of 11:59 p.m. Tuesday, December 22, there were 230 new deaths reported for a total of 14,442 deaths attributed to COVID-19. County-specific information and a statewide map are available on the COVID-19 Data Dashboard.
Mask-wearing is required in all businesses and whenever leaving home. Consistent mask-wearing is critical to preventing the spread of COVID-19.
There are 44,800 individualswho have a positive viral antigen test and are considered probable casesand 640 individualswho have a positive serology test and either COVID-19 symptoms or a high-risk exposure.
There are 3,181,266 individuals who have tested negative to date.
In nursing and personal care homes, there are 49,042 resident cases of COVID-19, and 8,942 cases among employees, for a total of 57,984 at 1,435 distinct facilities in all 67 counties. Out of our total deaths, 8,138 have occurred in residents from nursing or personal care facilities. A county breakdown can be found here.
Approximately 18,143 of our total cases are among health care workers.
COVID-19 Vaccine Distribution
Pennsylvania hospitals began receiving shipments of the Pfizer-BioNTech COVID-19 vaccine the week of Dec. 14 and Moderna COVID-19 vaccine the week of Dec. 21.
Through Dec. 22:
Through Dec. 23:
A spreadsheet of facilities that have received vaccine can be found here.
Statewide the Wolf Administration has since noon, Dec. 22:
The Wolf Administration stresses the role Pennsylvanians play in helping to reduce the spread of COVID-19:
Updated Coronavirus Links: Press Releases, State Lab Photos, Graphics
All Pennsylvania residents are encouraged to sign up for AlertPA, a text notification system for health, weather, and other important alerts like COVID-19 updates from commonwealth agencies. Residents can sign up online at www.ready.pa.gov/BeInformed/Signup-For-Alerts.
MEDIA CONTACT: April Hutcheson - RA-DHpressoffice@pa.gov
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The vaccines were prepared for shipments at the McKesson distribution center in Olive Branch, Miss. Wochit
The federal government is close to delivering 20 million doses of COVID-19 vaccine during the month of December, as promised, but states are taking longer than expected to get those doses into people's arms, officials admitted Wednesday.
About 15.5 million doses will be delivered by the end of the year, with the remaining 5 million arriving between Jan. 4-6, said Gen. Gus Perna, who co-leads Operation Warp Speed, the federal effort to develop and distribute COVID-19 vaccines, treatments and tests.
But only about 1 millionof the 9 million doses distributed so far have been reported administered,his co-leadMoncef Slaoui confirmed during a news conference.
Thedeath rate from COVID-19 in the U.S.reached an all-timehigh in the week ending Tuesday, and an American is dying of the virus every 32 seconds.
Reporting of the shots can take 3-4days, Slaoui said, sothe vaccination figures are probably better than theyappearbut there's still a substantial lag.
Where's the COVID-19 vaccine? Who's been vaccinated?Here's how we'll know.
"Exactly how fast the ramp-up ofimmunizations shots in arms is happeningisslower than we thought it would be," Slaoui said.
He offeredfederal help to states to accelerate that process. "It's important that the states are able to increase the cadence of immunization, but it's also important that they do it at a pace wherethey are in control, that no mistakes are made and no accidents are happening," he said. "That's super important."
The lag is likely caused by a variety of factors, including the logistical challenge of starting a new program, the difficulties of administering these vaccines, and the fact that many hospitals are nearly overwhelmed with COVID-19 patients right now.
"I don't think the rollout went as well as many of us would have hoped, saidDr. Daniel Griffin, an infectious disease specialist atProHEALTH Care in New York.
Nurse Debbie Mahoney administers a COVID-19 vaccine to nurse Alexa Zarlengo at Ascension Saint Thomas Hospital West in Nashville, Tenn., on Dec. 17.(Photo: Andrew Nelles, The Tennessean)
At first, the shots were not where the workers needed them to be, he said. The first weekthe Pfizer-BioNTech vaccine was available, he was offered a shotat 7:30 a.m. at a hospital 45 minutes fromwhere he works. Weekends were not an option.
This week, thearrival of the second vaccine, made by Moderna, has made a difference, he said. Griffin, who treated30 COVID-19 patients on Wednesday,was able to get his firstof the two-dose vaccine the same day.
Griffin said he imagined the vaccinations would be like the flu shot, where someone would walk over to him while he was seeing patients, he'd roll up his sleeve and get the shot. But with these vaccines, the person vaccinated has to wait around for 15 minutes tomake sure they're not having a bad reaction.
Your vaccine questions, answered: I had COVID, should I still get vaccinated? What are the side effects? What are its 'ingredients?'
He hopes things will go more smoothly with the next round of vaccinations, which will be distributed in the community, rather than at hospitals where the first priority has to be taking care of the sick.
The story is much the same at other hospitals.
"I suspect the efficiency of everybodys system will go up over time but Im not surprised that the injections arent quite keeping up with the supply,"said Dr. Robert Wachter, chair of the department of medicine at the University of California, San Francisco.
UCSF is vaccinating about 650-700 peopleper day, he said. So far,4,000 workers have been given shotsout of 11,000 doses received.
"You need enough people trained to do the shots, and a variety of other people to keep track of the flow," he said. Before getting vaccinated, people have to sign consent forms, which takes a few minutes, and then there's the 15-minute waiting period.
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Potential side effects from the vaccines also meanhospitalshave avoided vaccinating a whole departmenton the same day,to ensure workersdon't all get sidelinedat the same time, he said.
It's a logistical challenge to deliver the vaccine, agrees Dr. Otto Yang, a professor of infectious diseases at the David Geffen School of Medicine at UCLA.
"There needs to be staffing to give the vaccine, pharmacies set up to store the vaccine and distribute it to the clinic, as well as scheduling to have people come in and get the vaccine," he said.
Although the pace of vaccination may seem slow, it's actually astonishingly fast, considering that the first vaccine was only authorized for emergency use by the Food and Drug Administration 11 days ago, Yang said.
"If you do the math, since FDA approval, assuming an 8-hour work day, including weekends, that's 11,363 doses given per hour in this country," he said. "It's hard to imagine it going any quicker than that."
Hospital workers have been extremely eager to get vaccinated, saidDr. Paul Biddinger, medical director ofEmergency Preparedness, Mass General Brigham, a Boston-based hospital system.
Our spots are filling as quickly as we receive the vaccine and interest remains very high," he said.
Deliver a safe, effective COVID-19 vaccine in less than a year?Meet Moncef Slaoui.
Also Wednesday,Slaoui said studies will begin soon looking at whether the Moderna vaccine could be stretched by giving people lower doses. Right now, people are given 100 micrograms in each of two doses, he said, but early indications suggest that the 50-microgram dose might be equally effective.
Although a single dose of the vaccine appears to be very effective, he warned people against getting just one shot. A second dose usually trains the immune system to fight off a disease for longer, so the protection from one shot is not likely to last as long, he said.
Experts say side effects from the COVID-19 vaccine range from soreness to fatigue.(Photo: Getty)
Johnson & Johnson is testing a vaccine that could be given in just one dose. Their large trial is now fully enrolled and the first hints of its effectiveness should be available within a few weeks, Slaoui said. If that vaccine proves safe and effective, it is likely to win FDA authorization in February, adding 100 milliondoses to the U.S. supply.
A candidate vaccine developed by AstraZeneca in collaboration with Oxford University is also nearing full enrollment of its crucial American trial, he said, with authorization likely in late February or early March, if it proves safe and effective.
More US supply?FDA says Pfizer-BioNTech COVID-19 vaccine vials may hold extra 'obtainable' doses
Moderna and Pfizer-BioNTech have each promised to deliver 100 million doses in the first quarter of 2021 and another 100 million each in the second quarter.
If all those doses come through, the adult population will be more than covered by next summer, Slaoui said, noting that most of the 80-million Americans younger than 18 may have to wait until later in the summer, because trials on teenagers need to be completed before vaccine makers will extend their studies into younger children. The Pfizer-BioNTech vaccine is authorized for use in 16-17-year-olds.
Slaoui and Perna ended their talks Wednesday by thanking all the people who have been involved in developing, manufacturing and delivering the vaccines, as well as those who volunteered for the clinical trials.
"Thank you, thank you, thank you to the men and women who are on the front lines in our hospitals, emergency rooms, ICU'sthe doctors, thenurses, thepeople who support them 24/7, the people really on the front lines," Perna said. "Our hats are off to everything they do."
Contributing: Mike Stucka, USA TODAY
ContactKaren Weintraub at kweintraub@usatoday.com.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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In one of the Texas facilities hardest hit by the COVID-19 virus, Texas medical workers lined up to receive the Pfizer COVID-19 vaccine on Saturday. While a long road lies ahead and officials stress that people need to continue wearing masks and social distancing some who received the vaccine were optimistic that this could be the beginning of the end for the pandemic.
Disclosure: DHR Health has been a financial supporter of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.
Corrie Detweiler, a professor of molecular, cellular and developmental biology, eyes some samples in the lab. (Photo: CU Boulder)
As scientists around the globe wage war against a novel, deadly virus, one CU Boulderlab is working on new weapons to battle a different microbial threat: a rising tide of antibiotic-resistant bacteria which, if left unchecked, could kill an estimated 10 million people annually by 2050.
The COVID-19 situation is definitely putting us at risk for increasing resistance to antibiotics, so its more important now than ever that we come up with alternative treatments, said Corrie Detweiler, a professor of molecular, cellular and developmental biology who has spent her career seeking those alternatives.
In a paper published Dec. 18in the journal PLOS Pathogens, Detweiler and her research team unveil their latest discoverya chemical compound that works with a hosts innate immune response to push past cellular barriers that help bacteria resist antibiotics.
Along with their other recently published discoveries, the authors say, the finding could lead to a new arsenal for fighting what could be the next big public health threat.
If we dont solve the problem of finding new antibiotics or somehow making old antibiotics work again, we are going to see sharply increasing deaths from bacterial infections we thought we had beaten decades ago, said Detweiler. This study offers a totally new approach and could point the way toward new drugs that work better and have fewer side effects.
In the United States alone, 35,000 people die annually from bacterial infections that could not be treated because theyve grown resistant to existing drugs. Countless others suffer life-threatening bouts with once-easily treatable illnesses like strep throat, urinary tract infections and pneumonia. By 2050, the authors note, there could be more deaths from antibiotic resistance than from cancer.
As our existing antibiotics adapt and work less, we risk essentially going back to a period 100 years ago, when even a minor infection could mean death, said Detweiler.
The pandemic has shone even more light on the problem, she notes, as many patients die not from the virus itself but from hard-to-treat secondary bacterial infections.
Meanwhile, she and other scholars worry that heightened use of antibiotics to prevent or treat those secondary infections, while at times necessary, may be exacerbating resistance.
Fragile healthcare systems in many parts of the world may not withstand the COVID-19 pandemic if also faced with a substantial increase in antimicrobial resistance, wrote the authors of an editorial in the British Medical Journal in November.
Most antibiotics in use today were developed in the 1950s, and pharmaceutical companies have since scaled back on research in the field in favor of more profitable ventures.
To feed the pipeline, Detweilers lab developed a technique called SAFIRE for screening for new small molecules, which work differently than older drugs.
Of 14,400 candidates screened from a library of existing chemicals, SAFIRE identified 70 that hold promise.
The new paper centers around JD1, which appears to be particularly effective at infiltrating what are known as Gram-negative bacteria.
With a tough exterior membrane that prevents antibiotics from accessing the cell, and another interior membrane providing a buffer, these bacteria (including Salmonella and E. coli) are inherently difficult to treat.
But unlike other drugs, JD1 takes advantage of the hosts initial immune assault on that outer bacterial membrane, then slips inside and goes after the inner membrane too.
Professor Corrie Detweiler in her lab at CU Boulder
This is the first study to show that you can target a Gram-negative bacterias inner membrane by exploiting the innate immune response of the host, Detweiler said.
In laboratory and rodent experiments, JD1 reduced the survival and spread of Gram-negative bacteria called Salmonella enterica by 95%.
But while it damaged the bacterial cell membranes, it couldnt penetrate the fine layer of cholesterol that lined its mammalian hosts cell membranes.
Bacteria are vulnerable to JD1 in a way that our cells are not, said Detweiler, noting that for this reason, side-effects would likely be minimal.
Further studies are underway to explore JD1 and other compounds like it.
Meanwhile, Detweiler has formed a spin-off company to help commercialize other compounds that work by inhibiting pumps, called efflux pumps, that bacteria use to pump out antibiotics.
The reality is, evolution is way smarter than all of the scientists put together and these bacteria will continue to evolve to resist what we throw at them, she said. We cannot rest on our laurels. We have to keep feeding the pipeline.
The COVID-19 vaccine is using new technology that has never been used before in traditional vaccines. Here's how an mRNA vaccine works. USA TODAY
Two COVID-19vaccines are now authorized in the United States.
The Moderna vaccinebegan arriving across the nationMonday, just three days after it was authorized for emergency use by the Food and Drug Administration.It comes onthe heels of the Pfizer-BioNTech vaccine, which is being given to health care workers and nursing home residents.
As Americans prepareto get vaccinated, manyalsohave questions.What's the difference between these two vaccines, how effective are they, and when do we all expect to get them?
Heres what we know about the COVID-19 vaccines and what theymightmean forthe pandemic.
Pfizer and the German biotechnology company BioNTech developed one of the COVID-19 vaccines that has been authorized by the FDA, BNT162b2.
Moderna, a Cambridge, Massachusetts-based biotechnology company, developed a COVID-19 vaccine, mRNA-1273, that was authorized Friday.
All of the late-stage vaccine trials include at least 30,000 volunteers, half of whom receive the active vaccine and half the placebo.
Both vaccines require two doses. The Pfizer-BioNTech shots are being given 21 days apart.Modernas are given 28 days apart.
Beginning a week after the second dose, participants are watched to see whether they come down with COVID-19.
In each of the studies, after about 150 participants have developed COVID-19, it is statistically possible to determine the vaccine's effectiveness.
Almost 200 trial participants developed symptomatic COVID-19 in the Moderna trial, only 11 of whomhad received the active vaccine. Because the infection rate was so much higher in the placebo group, statistical analysis determined that the vaccine was 94% effective overall, according to safety and effectiveness data released Dec. 15.
Pfizer/BioNTech reported on Nov. 18 that of 170 confirmed cases of COVID-19 among its trial participants, 162 were in the placebo group versus eight in the vaccine group. A safety and effectiveness report released Dec. 8 confirmed thefindings.
In Modernas Phase 3 trials, the company said the most common side effects were fatigue, muscle soreness and aches, joint pain and headache, plus pain, redness or swelling at the injection site.
In Pfizer/BioNTech Phase 3 trials, many participants endured side effects for a day or two after getting their shots, particularly the second one. The most commonly reported side effect among vaccine recipients under age 55 was a sore arm, followed by fatigue (60% after the second shot); headache (52% after the second shot); other muscle aches (37%); and chills (35%). About 28% took pain medication after the first shot and 45% after the second shot.
A sore arm and feeling crummy for a day or two is a lot better than COVID, said Dr. William Schaffner, professor of health policy and of preventive medicine at the Vanderbilt University School of Medicine.
Physicians emphasize that the side effects are not just normal but also a sign that the body is reacting properly to the vaccine.
Side effects of theCOVID-19 vaccines look similar to side effects of the influenza vaccine, which includesoreness, redness, and/or swelling where the shot was given, headache, low-grade fever, nausea, muscle aches and fatigue, according to the Centers for Disease Control and Prevention.
In trials of 44,000 and 30,000 respectively, Pfizer/BioNTech and Moderna saw very few problemsmore serious than a couple of days of feeling lousy.
Four people in the Pfizer/BioNTech trial and three people in the Moderna trial developed Bell's Palsy, a neurological condition that leads to temporary drooping of one side of the face.
At least two people in Great Britain, where the vaccine was first approved and distributed, as well as several Americans have had powerful allergic reactions to the Pfizer-BioNTech vaccine so far, representing a tiny fraction of those vaccinated. The federal government is studying these reactions but has so far said the vaccine appears to be safe for anyone who has not previously had an allergic reaction to one of the vaccines' ingredients.
Most of the U.S.-backed vaccines target the spike protein found on the surface of the virus that causes COVID-19, which allows the virus to attach itself to host cells and infect them.
Both of these vaccines work by presenting this spike protein to the immune system. The spike proteins arent dangerous because the rest of the virus isnt present;however, the body now sees the protein and designs immune "soldiers" to fight it.
The Moderna and Pfizer vaccines deliver strands of genetic material known as mRNA, which turns peoples cells into spike protein factories.
In this special edition episode of States of America, experts answer the biggest questions Americans have about the vaccine, side effects, how it's getting to you and more. USA TODAY
This technology has never been used before in an approvedvaccine, though it has been tested against other diseases. The mRNA technology was chosen this time because scientists knew it could be developed quickly.
Other COVID-19 vaccine candidates being supported by the U.S. government target the spike protein via a different carrier virus or tiny particle.
The vaccines require different types of storage.
The Pfizer/BioNTech vaccine must be kept super-cold at the temperature of dry ice until shortly before it is used.The Moderna vaccine needs to be frozen if stored for a long time, but it can be refrigerated for up to a month before being used.
Since the Pfizer/BioNTech vaccine has been approved, health care workers and people in long-term facilities across the country have been lining up to get their scheduled vaccine.
A few high-profile politicians, such as Vice President Mike Pence and Florida Sen.Marco Rubio, were publicly vaccinated in hopes of instilling confidence in the vaccine.
A CDC advisory panel decided Sunday that police, firefighters, teachers and grocery workers will be among the next in line for a COVID-19 vaccine.
The committee vote recommended that Phase 1b include people 75 and older and front-line essential workers. They make up about 30 million people among these groups:
Because vaccine supplies are initially limited, Phase 1b isnt expected to begin until February.
Phase 1c will include people 65 to 74 and people 16 to 64 who have high-risk medical conditions, along with other essential workers. This would make up about 57 million people and would include:
Phase 2 would include all people 16 and over who were not in Phase 1 who are recommended for the vaccination. That means people 16 and over with high-risk medical conditions.
Coronavirus updates: Moderna vaccinations set to begin Monday; New York Gov. Cuomo urges feds to ban flights from UK
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the USA TODAY Editorial Board Nov. 18that he expectedthe general public to begin vaccinations as early as April.
Contributing: Karen Weintraub and Elizabeth Weise, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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The CEO of Howard University Hospital, a major health care provider for the African American community in Washington, DC, was well aware that her employees and staff had reservations about the vaccine. And that notion frightened her.
An internal hospital survey of about 350 employees in early November found that 70% were not willing to take the vaccine or would not take it immediately after it became available.
Even her own leadership team was hesitant. "I'll take it if you take it," some members told her.
"I said, 'I will gladly take it first,'" Jenkins told CNN.
So Jenkins received the first dose of the Pfizer vaccine on December 15 before cameras to instill confidence in the vaccine among her staff, becoming the latest high-profile health care professional to take such a step.
Alleviating her employees' fears has been a slow process, but Jenkins said she's optimistic.
Howard University Hospital received 725 doses of the Pfizer vaccine in its first shipment, with more vaccines expected this week. To date, the hospital said more than 350 staffers have received the vaccine out of the nearly 2,300 employees, residents and contractors who work there.
The numbers, while still low, exceeded expectations, Jenkins said. She added that the hospital expects to run out of its initial 725 doses "well ahead of schedule."
Building up trust has been a slow process
Jenkins' move is part of a widespread effort by community leaders and health care experts to combat vaccine hesitancy among Black and Latino Americans -- a particularly pressing problem given the disproportionate toll that the virus has taken on those communities.
Of those people, the majority said they were concerned about possible side effects; half were worried they would get Covid-19 from taking the vaccine; and 48% said they have a general distrust in vaccines.
Communities of color have "every right to be nervous," Jenkins said.
"This is not an American experiment on Black people," Jenkins said. "This is a worldwide pandemic with a worldwide vaccine as a solution to the thousands of deaths."
Since learning that so many staffers at Howard University Hospital did not yet feel comfortable taking the vaccine, Jenkins said she and her team have been putting out Q&As to address people's concerns.
She has also been personally answering questions from employees: Could they possibly get Covid-19 from the vaccine? What were the side effects? Was it safe for pregnant women? What about nursing mothers? What about those who were trying to get pregnant?
"I felt personally responsible to help people through not just misunderstandings, but misinformation, and to help them through their fears," Jenkins said.
The messages have continued even after she took the vaccine: Is she experiencing any side effects? (Nothing besides a sore arm the first day.) What about 48 hours later? (Still feeling good.) What about a week later? (Doing just fine).
That so many Black and brown people -- even those she's never met -- are coming to her with their fears and concerns has been humbling, Jenkins said. And it's a reminder of just how important it is for experts and professionals who look like the communities they serve to take the vaccine.
"I hope they trust us more because we can relate," Jenkins said. "I hope that they see us as one of them."
Other Black leaders have done the same
Dr. Valerie Montgomery Rice recently sent a similar message to Black Americans.
Rice, too, empathized with some Black Americans' concerns over the nation's history of racism in medicine. But she insisted that she wouldn't recommend a vaccine she didn't trust.
"We are in the rooms where it's happening," Rice said. "So we clearly are not going to go against ourselves. Because we understand how critical this is for Black America and Latinx America who have been disproportionately impacted by the virus."
Morehouse is among the historically Black colleges and universities, Black sororities and fraternities and prominent Black pastors who are leading national efforts to remove the stigma around the Covid-19 vaccine.
Other cornerstones in Black communities, like barbershops and hair salons, have also been playing a key role in the conversation. Stephen Thomas, a professor of health policy and management at the University of Maryland in College Park, is hosting Zoom town halls where doctors and scientists teach Maryland-based barbers, stylists and their clients about the vaccine.
The effort is part of Thomas' initiative Health Advocates In-Reach and Research, or HAIR, that provides cancer screenings at barbershops and hair salons.
"The barbers and the stylists have trust," Thomas said. "It's a big deal, it's a family affair. It's a place where Black people come together across all their socioeconomic divisions."
CNN's Nicquel Terry Ellis contributed to this report.
