Another shot in the arm as one-dose vaccine heads toward usage
The nation’s battle against COVID-19 is expected to get another weapon after the FDA said Johnson & Johnson’s vaccine provides strong protection.
The coronavirus vaccine made by Johnson & Johnson provides strong protection against severe disease and death from COVID-19, and might reduce the spread of the virus by vaccinated people, according to new analyses posted online by the company and the Food and Drug Administration on Wednesday.
The reports provided an in-depth confirmation of the initial results announced by Johnson & Johnson late last month, indicating that the United States is likely to soon have access to a third coronavirus vaccine developed in under a year. The FDA could authorize the vaccine as early as Saturday, depending on a vote by its vaccine ad
JOHNSON & JOHNSON’S VACCINE CAN KEEP FOR THREE MONTHS AT NORMAL REFRIGERATION TEMPERATURES, MAKING IT EASIER TO DISTRIBUTE AND EASIER FOR PHARMACIES AND CLINICS TO STOCK.
visory panel Friday, and distribution could begin within days.
If cleared, the vaccine would reach a number of firsts for the U.S. pandemic. Unlike the authorized vaccines made by Pfizer-BioNTech and Moderna, which require two doses, Johnson & Johnson’s is just a single shot, allowing the number of fully vaccinated Americans to rapidly increase once it is deployed. More than 44 million Americans have received at least one dose of the Moderna and Pfizer vaccines, but only around 20 million have received a second dose.
Those earlier vaccines use a new technology called mRNA that needs freezers for long-term storage. Johnson & Johnson’s vaccine, which uses sturdier viruses to deliver genes into cells, can keep for three months at normal refrigeration temperatures, making it easier to distribute and easier for pharmacies and clinics to stock. The White House on Wednesday said around 2 million doses would be ready to allocate to states next week, with up to another 2 million for pharmacies and community health centers.
The documents published by the FDA Wednesday showed that the new vaccine had an overall efficacy rate of 72% in the United States and 64% in South Africa, where a concerning variant emerged in the fall that is now driving most cases. The efficacy in South Africa was 7 percentage points higher than earlier data released by the company showed.
The vaccine also showed 86% efficacy against severe forms of COVID-19 in the United States, and 82% against severe disease in South Africa. That means that a vaccinated person has a far lower risk of being hospitalized or dying from COVID-19. None of the nearly 22,000 vaccinated people in the trial died of COVID-19.
“The vaccine has definitely met the bar of what’s worthy of rolling out and using. It’s performing well,” said Natalie Dean, a biostatistician at the University of Florida. Another authorized vaccine, and especially one that only requires one dose, could block the spread of the virus more effectively and drive down cases faster. “Having more products available is a huge advantage,” Dean said.
State health departments around the nation have been eager to take advantage of it. In North Dakota, which has one of the nation’s highest rates of vaccination, members of the state’s vaccine ethics committee met this week to discuss allocation and distribution of the vaccine, anticipating the FDA’s analysis, said Kylie Hall, a vaccine adviser for the state’s health department. The new data may help guide the state’s decisions on which people to prioritize for the small number of doses that may arrive next week, she said.
“It prevents severe disease and death from COVID,” she said. “That’s the best news we could have.”
But access to the new vaccine could be severely limited at first. Dr. Richard Nettles, vice president of U.S. medical affairs at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, told lawmakers Tuesday that nearly 4 million doses would be ready for shipment if the FDA authorizes the vaccine. That is far below the 12 million it had originally pledged to give the federal government by the end of February.
He said that a total of 20 million doses would be ready by the end of March, 17 million fewer doses than the firm’s federal contract envisioned. But he insisted that Johnson & Johnson would fulfill its promise of 100 million doses by the end of June.
Asked about the shortfall Wednesday, Jeff Zients, White House coordinator of the pandemic response, said that the Biden administration discovered when it took office five weeks ago that Johnson & Johnson was behind on manufacturing and needed federal help in obtaining equipment and raw materials.
“It was disappointing when we arrived,” he said, but “I think the progress is real.” He added: “Obviously the prospect of a potential third approved vaccine is very encouraging,” because lack of supply remains the biggest obstacle to the nation’s vaccination effort.
Johnson & Johnson’s vaccine has a lower efficacy rate than the vaccines from
Moderna and Pfizer-BioNTech, which are both around 95%.
But in South Africa, the Johnson & Johnson vaccine is so far the clear winner. Novavax’s shot had an efficacy of 49% in South Africa. And a small trial in South Africa of the AstraZeneca-Oxford vaccine found that it did not offer much protection at all. The negative results led the South African government to abandon its plan of giving 1 million doses of AstraZeneca vaccines to health care workers. Last week, the government started giving Johnson & Johnson’s vaccines instead, and has so far administered more than 32,000.
The newly released documents, which include the FDA’s first technical analysis of the company’s 45,000-person clinical trial, presented evidence that the vaccine was safe, with noticeably milder side effects than the Pfizer and Moderna vaccines and without any reports of severe allergic reactions like anaphylaxis.
The vaccine’s protection was consistent across
Black, Hispanic and white volunteers, and also across different ages. The trial estimated a lower efficacy, of 42.3%, for people over 60 who had risk factors like heart disease or diabetes, a figure that came with a large amount of statistical uncertainty, the FDA noted.
Dr. James Burke, an expert on trial design at the University of Michigan School of Medicine, cautioned that the results found in small subgroups can turn out to be the result of chance. “We’re wrong more than we’re right,” he said. “So we should always tread very cautiously.”
North Miami Beach City Manager Esmond Scott has resigned amid pressure from a divided city commission, which voted Monday night to grant him a severance package that includes a city-owned car and an eight-month consulting deal with the city at his current salary.
Scott, whose last day on the job was Tuesday, was the city manager since 2018 and a city employee since 1997. The announcement came about a month after one city commissioner moved to fire Scott, and on the heels of months of rumors about his job status during a hectic period for the city.
Assistant City Manager Horace McHugh will take over as the city’s interim manager as the city searches for a full-time administrator.
“It’s the end of an era,” Commissioner Barbara Kramer said at a ceremony Tuesday to celebrate Scott’s tenure. “I’m sure your phone is gonna be ringing off the hook because you’re such an amazing man, you’re such an amazing employee, and you’re such an amazing leader.”
Scott resigned about one month after Commissioner Paule Villard tried unsuccessfully to fire him during a late January commission meeting. During that same meeting, commissioners also voted to fire the law firm contracted to represent the city and hire a new contract city attorney.
But Scott won’t be going far. On Monday, he finalized a severance agreement with the city that will keep him on board as a consultant “as needed” until Oct. 31 at his current pay rate, which is over $200,000 per year. Scott will also keep his city-issued car, which is worth about $32,000, according to Commissioner Fortuna Smukler.
Scott’s resignation resurfaced tensions about turnover at the top of City Hall.
In late January, when the city commission voted 4-3 to fire its contract law firm and hire an interim firm, Mayor Anthony DeFillipo and other commissioners called for a vetting process and accused their colleagues of possible Sunshine Law violations.
On Monday, after Scott resigned, Commissioner Michael Joseph proposed that the city bring in Arthur “Duke” Sorey, the deputy city manager in neighboring
North Miami, as interim city manager. That set off the same commissioners who had opposed the cityattorney switch.
“I’ll be damned if you think you’re gonna pull this again,” Kramer said.
Kramer accused her colleagues of trying to “ram” Sorey’s hiring as interim manager “up our a--es ... like you did with the city attorney.”
“It is disgraceful and it is disgusting and I really hope that the authorities are watching this game,” she said.
Commissioner McKenzie Fleurimond, who had initially seconded Joseph’s motion to hire Sorey, later withdrew his support.
“In my heart of hearts, I think that we should have a minimal process, at least,” he said.
As the dust settles from Miami-Dade County Public Schools’ reorganization of top staff, another Cabinet member is leaving the school district.
Jose Dotres, the district’s Chief Human Capital Officer, has been tapped as the deputy superintendent of Collier County Public Schools. The move takes Dotres from the largest school district in the state and fourth-largest in the country to Florida’s 16th largest school district.
Collier County Public Schools has a total student population of 46,329, a fraction of Miami-Dade’s enrollment of 334,937.
Dotres’ wife, Maribel Dotres, longtime principal of Palm Springs North Elementary in northwest MiamiDade, is also leaving to serve as Collier’s administrative director over teaching and learning, according to Collier County Public Schools spokesman Chad Oliver.
She has served as Palm Springs North’s principal for at least a decade. The school has almost consistently earned A grades from the state.
Oliver told the Miami Herald that Jose Dotres did not apply for the job; Collier County school superintendent Kamela Patton made a contingent offer to Dotres to gauge interest. He said salary information has not been finalized for either Dotres. Collier last had a deputy superintendent in 2017.
Jose Dotres, 58, makes a salary of $191,538 with Miami-Dade Schools and Maribel Dotres, 51, makes $129,049. Jose Dotres is expected to begin working for Collier on April 1.
Patton used to work for Dotres in Miami-Dade County Public Schools. She was a region director under Dotres while he was a region superintendent. Patton spent 25 years in Miami-Dade before she was hired as Collier’s superintendent in 2011.
Dotres has worked for Miami-Dade since 1988, though he spent the 2013-14 school year as Broward County Public Schools’ Chief Academic Officer. He returned to the district in 2014 to serve as Superintendent Alberto Carvalho’s chief of staff.
Dotres has not submitted a resignation letter, said Miami-Dade school district spokeswoman Jackie Calzadilla. She did not say who would replace him.
“Mr. Dotres has been a trusted member of our school system,” Calzadilla wrote in an email. “However, as a result of the strong succession management plan we have in place covering all essential personnel, his resignation will not present a challenge in continuity of leadership in that division.”
Dotres did not respond to requests for comments.
In a statement, MiamiDade School Board chair Perla Tabares Hantman called Dotres, “a well respected educator and administrator with a wealth of organization knowledge and experience.”
“At a personal level, I have a great deal of respect and admiration for Mr. Dotres,” she said.
School Board vice chair Steve Gallon also gave this comment after publication.
“The departure of Mr. Dotres will leave a huge void in the District,” he said. “His decades of experience as a teacher, principal, Region Superintendent, and most recently Human Capital Officer has distinguished him as a highly regarded and beloved educational professional. Collier County is fortunate to receive an educational professional of his caliber. Their gain is truly our loss.”
With simultaneous retirements and departures, the Miami-Dade County Public Schools underwent a significant reorganization of top staff in January, though it was narrowly approved by the School Board in a 5-4 vote. Two Cabinet members retired, two left for other jobs and one was laterally moved into a position that had been vacant for almost three years.
Former Chief Academic Officer Marie Izquierdo moved to Chief Strategy Officer, a position last occupied by Lisa Martinez in summer 2018. Izquierdo is now in charge of creating the district’s five-year plan, which expired at the turn of the year.
In her new post, Izquierdo keeps her salary of $181,896 despite having no employees under her, unlike in her role over academics. She remains in the district’s highest pay grade, even though Martinez, her predecessor, was paid one pay grade below. When the School Board approved the Chief Strategy Officer position as part of a reorganization in 2014, the job called for the highest pay grade.
Carvalho said Izquierdo’s past accomplishments with the district, such as her work on the $1.2 billion general obligation bond passed by voters in 2012, should not be overlooked. Izquierdo has worked for the district for almost 30 years.
But Izquierdo also signed off on K12, the company that created the online learning platform used by the district when school began, which was pulled after teachers and parents complained vociferously.
“We were victims of K12,” Carvalho said, defending Izquierdo.
Iraida Mendez-Cartaya, the district’s former associate superintendent over the office of intergovernmental affairs, recently left to serve as chief of staff to new Miami-Dade County Commissioner
Rene Garcia.
Mendez-Cartaya told the Herald she left for personal reasons, one of them being to spend more time with her family. She took a $20,000 pay cut for the job, now making $161,130 compared to her school district salary of $180,813.
The school district also has two chiefs of staff on its payroll temporarily. A school district spokeswoman said a transition period is part of succession management and considered best practice.
Jaime Torrens, who has been eligible for retirement but kept working for the district on a temporary waiver during the coronavirus pandemic, will stay on though June 30 earning his $200,331 salary.
Former North Region superintendent Jose Bueno has already been promoted to replace Torres as Carvalho’s chief of staff, earning a salary of $163,564.