The Latest: J&J Applies To WHO For COVID Vaccine Approval
Feb 19, 2021, 4:15 PM | Updated: 4:22 pm
(Photo by Guillermo Legaria/Getty Images)
NEW BRUNSWICK, New Jersey (AP) — Johnson & Johnson has applied to the World Health Organization for an emergency approval of its COVID-19 vaccines, which should help speed up its use in countries around the world.
J&J said Friday that its Janssen-Cilag International subsidiary has submitted to the WHO the last testing data needed on its vaccine’s efficacy and safety, completing the New Brunswick, New Jersey company’s application for an emergency use listing.
Obtaining that listing will expedite access to J&J’s single-dose vaccine for United Nations procurement agencies and scores of countries. The listing also is required for Johnson & Johnson to supply doses of its vaccine to what’s called the COVAX Facility, a WHO-backed project to ensure equitable access to vaccines for about 190 low- and middle-income countries. Johnson & Johnson in December agreed to provide up to 500 million doses of its vaccine to COVAX through 2022.
“If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries,” Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels said in a statement.
The company is supplying the vaccine at not-for-profit prices during the pandemic’s acute phase.
Besides requiring only one dose, J&J’s vaccine can be stored for at least three months at standard refrigerator temperatures, making it a good fit for poor and rural areas and developing countries that lack infrastructure for the ultracold storage some other COVID-19 vaccines require.
Interim results from a 44,000-volunteer late-stage testing found the Johnson & Johnson vaccine was 66% effective at preventing moderate to severe cases of COVID-19 in Latin America and 57% effective in South Africa, where a more-contagious variant is spreading. It was 72% effective in the U.S.
Testing also indicated the vaccine was 85% protective against the most serious symptoms — and starting 28 days after their shot, researchers found no one who got the vaccine needed hospitalization or died.
THE VIRUS OUTBREAK:
— ‘Alone’: A year later, how Italian town with country’s 1st known virus death fared
— Africa reaches 100,000 known COVID-19 deaths as danger, vaccine concerns grow
— Old habits imperil Iraq as doctors warn of second virus wave
— Joe Biden will use his first big presidential moment on the global stage at Friday’s Group of Seven meeting to announce that the U.S. will begin releasing $4 billion to supply poor nations with coronavirus vaccines.
— Millions of vulnerable U.S. residents will need COVID-19 vaccines brought to them because they rarely or never leave their homes.
— The large number of restaurants that went out of business due to the pandemic has been a boon for commercial auctioneers that buy used equipment and resell them to the eating establishments that managed to stay afloat.
HERE’S WHAT ELSE IS HAPPENING:
LAS VEGAS — Nevada is still waiting for a shipment of COVID-19 vaccines that were supposed to arrive this week but were delayed by winter storms blanketing much of the U.S.
Candice McDaniel, the health bureau chief of Nevada’s Bureau of Child, Family and Community Wellness, said Friday that the majority of the Moderna doses that were expected to arrive this week had still not arrived as of Friday morning.
She said health officials were in close contact with the U.S. Centers for Disease Control and Prevention to get updates on the shipment but said they’re “in a holding pattern.”
The Southern Nevada Health District said earlier this week that because of the delayed vaccines, it would be postponing about 4,000 appointments for second doses expected to occur this week and instead rescheduling them for next week.
First-dose appointments scheduled for this week were not affected, nor were appointments involving the Pfizer vaccine.
HONOLULU — Hawaii was still waiting on 27,700 doses of the Moderna vaccine but Lt. Gov. Josh Green said he expects them to arrive next week if they don’t arrive this weekend. He expects Hawaii will get caught up in its vaccinations next week too unless the storms on the U.S. mainland get worse and cause more delays.
Weather is always a risk, even for Hawaii, when products travel through states prone to winter storms.
Hawaii still managed to vaccinate 10,712 people on Thursday, which is a typical daily number for the state, Green said. Some hospitals on Oahu, the island where Honolulu is located, moved doses around to make sure people scheduled to receive their second shots got them on time. “They really are working like a team,” Green said.
OKLAHOMA CITY — The rolling average of new coronavirus cases in Oklahoma has been more than cut in half, according to data from Johns Hopkins University on Friday.
The seven-day rolling average of new cases in the state during the past two weeks has declined from 2,233 per day to 1,010.71 while the rolling average of daily deaths fell from 36.86 to 23.43, according to the Johns Hopkins data. There have been a reported 417,345 total virus cases and 4,132 deaths since the pandemic began, according to the Oklahoma State Department of Health.
The state health department has scheduled vaccination clinics during the weekend to replace those postponed due to a winter storm.
BELGRADE, Serbia — Djordje Balasevic, a Serbian singer who remained widely popular throughout the former Yugoslavia after the wars of the 1990s, has died after contracting the new coronavirus, state television reported Friday. He was 67.
Balasevic was admitted to a hospital in the northern Serbian city of Novi Sad three days ago suffering from pneumonia that appeared to be a complication of COVID-19. State broadcaster RTS said he died at the hospital on Friday.
Balasevic launched his career in the late 1970s and early 1980s, first performing in bands before establishing a solo following with his soft pop music and witty lyrics.
When Yugoslavia disintegrated in ethnic warfare in the early 1990s, Balasevic openly opposed the nationalism that fueled the conflicts. Because of his positions, mainstream media in Serbia shunned Balasevic during the war era.
But he remained well-liked throughout the ethnically divided Balkans region after the wars, filling up concert halls in all the countries that emerged from the six former Yugoslav republics. His performances were famous for his on-stage comments on various topics.
TORONTO — A lockdown and stay at home order is being extended in Toronto until at least March 8.
The lockdown in Canada’s largest city began Nov. 23 after a second coronavirus wave hit the province. Ontario Health Minister Christine Elliott says it was a difficult, but necessary decision to keep the areas under tight public health measures.
Toronto officials asked the provincial government this week to extend the lockdown after Toronto’s medical officer of health said she has never been more worried about the future because of new coronavirus variants.
Schools just reopened in Toronto this week and retail stores had been scheduled to reopen Feb. 22.
The stay-home order was lifted for the majority of the province earlier this week as the government moved ahead with an economic reopening despite warnings it could set off a third wave of infections.
The lockdown is also being extended in Peel and North Bay-Parry Sound regions. Scientists say the U.K. variant found in Ontario spreads more easily and is likely more deadly, but so far existing vaccines appear to be effective against it. Canada has had a shortage of vaccines until this week.
BOSTON — The medical director of the city agency coordinating Boston’s response to the coronavirus pandemic has been working remotely from Hawaii for several months, and even though she has permission to do so, some critics say it may hinder her effectiveness.
Dr. Jennifer Lo relocated with her family in November with approval from Rita Nieves, the Boston Public Health Commission’s executive director, NBC10 Boston reported Friday.
Atyia Martin, a former director of disaster preparedness for the commission, said she was shocked to learn Lo was working from so far away.
“We are in what amounts to the Super Bowl of emergencies,” she said. “It’s hard to imagine that key members of the team aren’t there in the game physically to play.”
Lo, in an email to the station, said she and her husband made “the difficult decision” to temporarily relocate to Hawaii for personal reasons, including to take care of two sets of aging parents. She offered to resign and plans on returning to Massachusetts this summer.
ROME — Italian police investigating fake COVID-19 drugs and vaccines have interviewed a Veneto regional official who reported receiving offers for 27 million doses of Pfizer outside the European Union contracting system.
For weeks, Veneto’s regional governor, Luca Zaia, reported being contacted by unnamed intermediaries offering to sell him shots, including Russian and Chinese jabs, after he publicly voiced frustration over shortages of deliveries in Italy and said he wanted to buy his own vaccines outside the national scheme.
On Friday, Zaia said his health care chief dealing with the offers, Dr. Luciano Flor, met with the carabinieri’s health care squad. The squad confirmed it was searching Veneto regional offices “to look into the presumed providers of vaccines outside agreements with central authorities.”
BOISE, Idaho — Public health officials say an Idaho man has been infected with a variant of coronavirus first detected in South Africa.
Idaho Department of Health and Welfare and Southwest District Health officials said Friday the man had recently traveled overseas and is thought to have been exposed before returning to Idaho.
Officials were working to identify people who may have had close contact with the infected man.
The variant is believed to be more infectious than other variants of the coronavirus that are currently prevalent in Idaho.
So far there have been at least 19 confirmed infections reported from 10 states with the variant first found in South Africa. Two other variants — one first discovered in California and another in the United Kingdom — were also recently found in wastewater tested from several Ada County cities.
WASHINGTON — White House coronavirus adviser Andy Slavitt says the drive to vaccinate Americans against COVID-19 has been set back by the winter storms that have spanned the country, shutting down transportation hubs and highways. But Slavitt says it’s possible to catch up with a concerted effort.
The weather has led to a 3-day delay in shipping vaccine, or about 6 million doses. Slavitt says the vaccine won’t spoil and is “safe and sound” in warehouses.
But as shipments resume and scale up, vaccinators in communities across the country are going to have to work overtime to get shots into arms.
“We as an entire nation will have to pull together to get back on track,” Slavitt told reporters at the White House coronavirus briefing.
About 1.4 million doses were being shipped Friday and the rest of the backlog should be cleared in several days.
In addition, the government is opening up five new mass vaccination centers, one in Philadelphia, and four others in the Florida cities of Miami, Orlando, Tampa and Jacksonville.
MADRID — Spain’s two-week incidence rate of COVID-19 per 100,000 inhabitants dropped further Friday, to 295.
That’s the lowest rate since Jan. 5 and down from a peak of nearly 900 at the end of last month.
The total number of new cases has been slowing in Spain for several weeks, but improvements are uneven across the country. The Madrid region is easing restrictions in some areas from Monday, for example, while Catalonia is keeping most limits in place for at least another week.
WASHINGTON __ Dr. Anthony Fauci is pushing back against some scientists who urge that as many Americans as possible get at least one dose of coronavirus vaccine, even if that creates supply shortages that delay required second doses. Proponents of the strategy say the spread of more aggressive virus mutations makes it imperative that as many people as possible get at least some protection right away.
But the government’s top infectious disease specialist says such an approach could backfire, giving people only fleeting protection, and perhaps even leading to more resistant mutations of the coronavirus.
“That could happen theoretically because of the immunological pressure on the virus,” Fauci said at Friday’s White House coronavirus briefing. “You might accidentally be inducing more variants.”
Fauci said “given the information we have now, we will stick with the scientific evidence” that the Pfizer-BioNTech and Moderna vaccines approved in the U.S. should be administered as a two-shot regimen.
Fauci acknowledged that even one shot provides protection against COVID-19, but he explained that without a timely second shot that protection could prove fleeting. “We don’t know how durable it is,” he said.
PHOENIX — Arizona announced it would provide $100 million of federal funding to the state’s 15 counties for COVID-19 testing.
The state Department of Health Services said the $100 million represents an initial amount and is being provided for staffing, laboratory testing “and other activities critical to combating COVID-19.”
The department’s announcement of the funding followed Pima County officials’ recent declaration that they might halt COVID-19 testing as of Monday because of a lack of funding.
CHARLESTON, W.Va. — West Virginia Gov. Jim Justice has ordered the loosening of pandemic restrictions on businesses after a decline in coronavirus deaths and cases, and he sought the return of all elementary and middle school students to in-person learning.
The governor said small businesses and grocery stores can double their allowed capacity and the limit on social gatherings will go up from 25 to 75 people. Bars and restaurants can allow 75% of seating capacity, up from 50%, if social distancing is possible.
Justice said all teachers and school workers over the age of 50 who accepted the offer for a vaccine will be given their second doses next week. He is asking the school State Board of Education to bring all students from kindergarten to eighth grade back to classrooms.
Justice said “without any question” parents would still have the right to keep their students at home with virtual learning.
NEW YORK — New data indicate the COVID-19 vaccine developed by Pfizer and German partner BioNTech could be stored for two weeks without the ultracold storage currently required, potentially making its use a bit easier.
The companies said Friday they’ve submitted findings from ongoing stability testing to the U.S. Food and Drug Administration, which has authorized the vaccine’s emergency use in the U.S., and will send the data to regulators around the world in the next few weeks.
The companies want regulators to update temperature requirements to state the vaccines can maintain their potency for two weeks if kept at -13°F to 5°F (-25°C to -15°C), as an additional option.
Freezers and refrigerators used in many pharmacies and hospitals commonly chill to those temperatures — but not to the temperature range
currently authorized, from -112°F to -76°F (-80°C to -60°C). The vaccine can remain stable at those temperatures for up to six months.
That’s why New York-based Pfizer and BioNTech ship the vaccine vials in special thermal containers that can serve as temporary storage for up to 30 days by repeatedly adding dry ice. Still, that can make storing and then thawing and administering the two-dose vaccine challenging in many places, particularly developing countries.
The shot is one of just two vaccines that have emergency use authorization in the U.S., though a third vaccine, created by Johnson & Johnson, is expected to win FDA clearance for emergency use within two weeks.
ORLANDO, Florida — Walt Disney World in Florida turns 50 in October and going ahead with its celebration amid the ongoing pandemic.
Plans for the 18-month birthday party which starts in October are being made amid one of the toughest stretches the resort the size of the city of San Francisco has faced in its nearly 50 years. Last spring, Disney World closed for two months to help stop the spread of the new coronavirus, leading to the temporary furlough of 43,000 workers.
Last fall, the company announced layoffs for 28,000 workers from its parks division in Florida and California due to limits on attendance and other pandemic-related issues. Disney officials said last November that revenue at its parks, experiences and products business fell 61% to $2.6 billion.
LONDON — A closely monitored survey has found that new coronavirus infections across the U.K. have fallen sharply, just days before Prime Minister Boris Johnson outlines a roadmap as to how lockdown restrictions in England can be eased in the weeks and months to come.
The Office for National Statistics said in its weekly infection survey that rates of transmission have fallen across all four U.K. nations. In England, it estimated that in the week to Feb. 12, one in 115 people tested positive for COVID-19. In the previous week, the rate stood at one in 80.
A similar picture emerged in the other three nations of the U.K. — Scotland, Wales and Northern Ireland.
BRUSSELS — The European Union’s executive commission plans to double its contribution to the World Health Organization’s COVAX program, bringing the 27-nation bloc’s commitment to the initiative to deliver vaccines to poor nations to 1 billion euros ($1.2 billion).
According to an EU official who spoke anonymously, European Commission President Ursula Von der Leyen will make the announcement later Friday during a meeting of the leaders of the Group of Seven economic powers.
The official was not authorized to speak publicly because details have not been made public.
Von der Leyen will also announce an additional 100 million euros ($121.4 million) to support vaccination campaigns in Africa in partnership with the Africa Centers for Disease Control and Prevention.
The EU is one of the leading donors to the COVAX program, which aims to ensure equitable access to COVID-19 shots for low-and middle-income countries. COVAX hopes to deploy some 336 million doses by the end of June, and around 2 billion doses by the end of the year.
But the program has already missed the goal of starting vaccination in poor countries at the same time that doses were rolled out in rich countries.
— Reported by Lorne Cook