OTTAWA, Ontario - Plans to distribute the first 300,000 doses of the Johnson & Johnson COVID-19 vaccine in Canada next week are on hold after Health Canada learned part of them were manufactured at a Maryland facility that messed up the ingredients in 15 million doses bound for the U.S. market.
The Emergent Biosolutions facility in Baltimore was recently cited by the U.S. Food and Drug Administration for violations including cleaning and sterilization failures, the potential for cross-contamination and failure to follow required protocols.
The FDA ordered the facility to stop making more J&J vaccine until the problems are corrected and the earlier mistake on the doses resulted in all 15 million being destroyed.
Health Canada had already cleared 1.5 million doses of the Oxford-AstraZeneca vaccine made at the facility, but did not think the Canadian J&J doses had any connection to that plant. Now Health Canada says the drug substance that makes up part of the J&J vaccine was actually produced there and then shipped elsewhere for the vaccines to be finished.
Health Canada says it is seeking information from the FDA and J&J’s pharmaceutical arm, Janssen, to determine if the 300,000 doses shipped to Canada meet required safety standards.
The J&J vaccine has not been used in Canada so far. The doses arrived in Canada on Wednesday.
THE VIRUS OUTBREAK:
- US keeps in place mask requirement on planes, transit
- Canada to get Pfizer vaccines from US next week
- US to restrict travel from India because of coronavirus surge
- Number of Americans fully vaccinated tops 100 million
Follow more of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine
HERE’S WHAT ELSE IS HAPPENING:
ATLANTA - Georgia’s governor is removing many remaining requirements for social distancing and masked employees from Georgia businesses.
Gov. Brian Kemp says the state’s efforts to control COVID-19 have been successful even as its vaccination rate lags and federal officials continue to warn that the infection rates remain relatively high.
The Republican Kemp had imposed mask mandates on many businesses. Except for in the health care sector, he lifted those on Friday. Among other changes, restaurants are no longer required to have any distance between tables.
Kemp says social distancing is now only “strongly encouraged,” not required. Movie theaters are no longer required to enforce any seating distance between unrelated customers.
“Georgians know best how to protect themselves and their families, and they deserve to be able to return to normal,” said Mallory Blount, a spokesperson for Kemp.
But public health experts fear another surge, possibly driven by more infectious variants of the virus.
“Too soon,” Emory University infectious disease expert Carlos del Rio wrote on Twitter, pointing to federal statistics.
ANCHORAGE, Alaska — Alaska Gov. Mike Dunleavy ended the state’s disaster declaration for COVID-19, saying the state is in a position where the declaration is no longer necessary.
He says the systems put into place are fully functional for vaccine distribution, testing and health care capacity. Dunleavy says it’s important to get the state’s economy back on track and get tourists to Alaska this summer.
Health commissioner Adam Crum says while COVID-19 is still present in Alaska, the urgent nature of the pandemic has passed in Alaska.
He says officials also no longer anticipate the widespread emergency that the state earlier faced in the pandemic.
WASHINGTON - The Transportation Security Administration has extended a requirement that passengers on planes, trains and buses wear face masks.
The rule was set to expire May 11 but will run through Sept. 13. TSA says children up to 2 and people with certain disabilities will continue to be exempted from the rule.
Airlines and their unions had pushed for an extension, saying mandatory masks have helped keep passengers and airline workers safe during the pandemic.
The Federal Aviation Administration says it will continue its zero-tolerance policy against disruptive airline passengers as long as the mask rule is in effect. That policy has led to fines against a few passengers, sometimes over refusal to wear a mask.
SALEM, Ore. - Gov. Kate Brown on Friday defended her decision to implement further restrictions in one-third of Oregon’s counties, saying for the second week in a row the state leads the nation with the fastest growing infection rate and that she is “gravely concerned” about hospital capacity.
Restaurants in 15 counties were required to close their indoor dining Friday and capacity was significantly reduced in gyms and indoor entertainment spaces. The restrictions have been criticized by business owners and Republican lawmakers.
“I was presented with data showing two paths that Oregon can take - one in which we took no additional action and stood by while more people die from this disease,” Brown said during a news conference Friday. “Or another that would require a temporary tightening of restrictions for certain counties, but could save hundreds of lives…I chose to save lives.” Brown says she intends to fully reopen the economy by the end of June.
This week, the Oregon Health Authority reported that the state recorded its fifth straight week where cases have increases by 20% more. About 80% of the state’s staffed adult ICU beds and 90% of the state’s staffed adult non-ICU beds are occupied, based on Oregon Health Authority data provided. Since the beginning of the month, COVID-19 hospitalizations have more than doubled. As of Thursday, 339 people were hospitalized with the virus in Oregon.
JACKSON, Miss. - Mississippi Gov. Tate Reeves on Friday erased most restrictions he had set to try to slow the spread of the coronavirus.
The Republican governor left one restriction in place - a mandate for students who are 6 or older to wear masks in schools for the rest of the current academic year. The school year ends within the next few weeks in most parts of the state.
The governor’s new executive order removes capacity restrictions for sports events. Previously, indoor arenas could only fill two-thirds of their seats to allow for social distancing. School sporting events and other extracurricular activities were limited to 50% capacity for both indoor and outdoor events.
Reeves had already removed mask requirements in public spaces and all capacity restrictions for restaurants, bars and other businesses.
The governor said he still encourages people to wear face coverings, maintain social distance and wash their hands while around other people. He said people who feel sick or have symptoms of COVID-19 should not attend social events.
OKLAHOMA CITY — Mask mandates intended to slow the spread of the coronavirus are ending in Oklahoma’s two largest cities, Oklahoma City and Tulsa. The requirement ended Friday in Oklahoma City and comes to an end Saturday in Tulsa, although the mandate continues at places such as city offices in both cities. Mayors David Holt in Oklahoma City and G.T. Bynum in Tulsa both credited virus vaccinations for lowering the number of virus cases and hospitalizations.
Bynum said residents should also continue wearing masks when in groups of non-family members. In both cities, private businesses can continue requiring masks if desired.
WASHINGTON - The U.S. will restrict travel from India starting on May 4, the White House said Friday, citing a devastating rise in COVID-19 cases in the country and the emergence of potentially dangerous variants of the coronavirus.
White House press secretary Jen Psaki said President Joe Biden’s administration made the determination on the advice of the Centers for Disease Control and Prevention.
“The policy will be implemented in light of extraordinarily high COVID-19 caseloads and multiple variants circulating in the India,” she said.
With 386,452 new cases, India now has reported more than 18.7 million since the pandemic began, second only to the United States. The Health Ministry on Friday also reported 3,498 deaths in the last 24 hours, bringing the total to 208,330. Experts believe both figures are an undercount, but it’s unclear by how much.
PHOENIX - State health officials say numerous doctors’ offices and clinics in Arizona will be able to directly obtain COVID-19 vaccines starting next week.
Arizona Department of Health Services Director Dr. Cara Christ announced Friday that eligible physicians and local health care providers will no longer have to rely on allocations from their county.
This means nearly 1,200 providers registered with the state can order up to 200 doses within a two-week period from the Centers for Disease Control and Prevention. They will receive the Moderna vaccine because it has less complex storage requirements.
More than 2.9 million people, or around 40% of Arizona’s population, have gotten at least one vaccine dose.
BEND, Ore. - A COVID-19 vaccine clinic set up inside a Bend, Oregon high school attracted anti-vaccine protesters who heckled teenagers as they entered the site. The Bend La Pine School District is offering the vaccine at six different clinics at Central Oregon high schools between now and June 3 in hopes of stemming an outbreak that’s sickened at least 95 students and staff in the district, The Bulletin reported Friday.
Students showing up for shots at the first event were heckled by protesters and the school board has received hate mail over the decision to hold the clinics.
DALLAS - Cruise lines are cheering word the U.S. Centers for Disease Control and Prevention is committed to resuming sailings in the United States by mid-summer and tweaking some of the rules around resuming trips.
A spokeswoman for the Cruise Lines International Association says the group’s experts are still reviewing the CDC comments but show progress in discussions to restart cruising.
This week, the CDC said in a letter to the group that it will let ships cruise without going through practice trips if 98% of the crew and 95% of passengers are fully vaccinated against COVID-19. The agency also promised a quick review of plans for practice voyages – five days instead of 60 – and changes in testing for fully vaccinated people.
The CDC had previously set conditions that the cruise industry said effectively prevented it from sailing to U.S. ports while the Caribbean and parts of Europe were opened to cruising. U.S. cruises have been shut down by the pandemic since March 2020.
WASHINGTON - Dr. Leana Wen, an emergency room doctor and former Baltimore health commissioner, says fully vaccinating about 40% of American adults is a great achievement, but not enough.
Dr. Wen believes the combination of better weather and falling case counts will make it harder to reach people who have not yet been vaccinated this summer.
“Those people who are on the fence about getting a vaccine may have less reason to get one now because they don’t see coronavirus as an existential crisis anymore,” says the visiting professor of health policy at George Washington University in a phone interview with the Associated Press.
Wen is concerned that could lead to a resurgence in cases this fall and winter as weather forces people back indoors and new variants of the disease become more prevalent. She says to reach the unvaccinated, the U.S. needs to make vaccines available in more places — doctor’s offices, workplaces, schools and churches.
NEW YORK - U.S. health officials have concluded that anxiety – and not a problem with the coronavirus vaccine - caused fainting, dizziness and other short-term reactions in dozens of people this month.
Health experts say the clusters are an example of a phenomenon that’s been chronicled for decades from a variety of different vaccines. Some people get so anxious about getting injections, it spurs physical symptoms.
Many of the 64 people affected either fainted or reported dizziness. Some got nauseous or vomited. A few had racing hearts or chest pain. None got seriously ill.
The report indicated those incidences happened in California, Colorado, Georgia, Iowa and North Carolina.
TORONTO - Drugmaker Pfizer says it will start sending U.S.-produced COVID-19 vaccines to Canada next week.
It’s the first time the U.S. has allowed that company’s vaccine exported north. Canada has close commercial ties with the U.S., but it has been getting Pfizer vaccines from Belgium.
U.S. authorities had kept supplies made in the U.S. for domestic use. Prime Minister Justin Trudeau says starting next week, Canada will be receiving 2 million doses a week from Pfizer alone.
Vaccinations have ramped up in Canada in recent months. All adults in Quebec will be eligible to make a vaccine appointment starting May 14. In Ontario, Canada’s largest province, adults can book an appointment starting May 24.
ANAHEIM, Calif. — Disneyland has reopened after a 13-month closure because of the coronavirus.
The iconic theme park in Southern California was closed under the state’s strict virus rules. It opened its gates Friday and some visitors came in cheering and screaming with happiness.
Capacity is limited and only in-state visitors are allowed. Hugs and handshakes with Mickey are also out. Industry experts say the reopening could encourage more Californians to travel during a downturn in virus cases.
California has the country’s lowest rate of coronavirus cases, and more than half of eligible residents have received a vaccine dose. It’s a dramatic turnaround from December, when hospitals across the state were running out of ICU beds and treating patients at overflow locations.
Now, children are returning to school and shops and restaurants are expanding business. Gov. Gavin Newsom set June 15 as a target date to further reopen the economy, with some health-related restrictions.
ROME - Italy’s Health Ministry Undersecretary Pierpaolo Sileri says he hopes tourism by visitors from the United States will be allowed sometime in June.
Tourism is one of Italy’s major industries, and U.S. tourists are a significant segment, especially for high end hotels and restaurants, including in cities like Venice, Florence and Rome.
Sileri, who is a medical doctor, was asked about a start date for tourism by Americans who have been vaccinated. He says it all depends on coronavirus transmission rates and the overall pandemic situation.
But he expressed optimism they might come soon and without need for quarantine.
LOS ANGELES - Los Angeles Mayor Eric Garcetti says the COVID-19 mass vaccination site at Dodger Stadium will close by the end of May.
Winding down operations at the stadium marks the transition of the city’s vaccination efforts to appointment-free options as well as putting more doses into walk-up centers and mobile clinics, the mayor said in a statement.
The Dodger Stadium site became one of the nation’s most prominent sites for coronavirus response, first for testing and then delivery of vaccine doses to people waiting in long lines of cars.
More than 1 million people were tested at the stadium and the number of vaccine doses administered there has topped 420,000, according to the city.
Cases and deaths have plunged in Los Angeles County, and the numbers remain low and stable. The county Department of Public Health said Thursday the daily test positivity rate was just 0.8%.
WASHINGTON - About 8% of Americans who have received one dose of either the Pfizer or Moderna COVID-19 vaccines have not returned for their second shot.
That’s according to Dr. Antony Fauci, the nation’s top infectious disease expert. He says it is important for those getting one of the two-dose vaccines to complete their course to gain maximum protection against the virus.
Speaking during a White House briefing, he pointed to several scientific studies showing significant benefits of the second shot, including reducing the risk of infection and strengthening the response of the immune system to the virus.
Says Fauci: “Get vaccinated, and if you’re getting a two-dose regimen, make sure you get that second dose.”
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