WASHINGTON — Results from a U.S. trial of AstraZeneca’s COVID-19 vaccine may have used “outdated information,” U.S. federal health officials say.
The Data and Safety Monitoring Board said in a statement early Tuesday that it was concerned that AstraZeneca may have provided an incomplete view of the efficacy data.
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that could help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.
In the study of 30,000 people, the vaccine was 79% effective at preventing symptomatic cases of COVID-19 — including in older adults. There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.
The company aims to file an application with the Food and Drug Administration in the coming weeks, and the government’s outside advisers will publicly debate the evidence before the agency makes a decision.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.
————
THE VIRUS OUTBREAK:
— Germany is extending its lockdown by another month and imposing new restrictions to drive down the rate of infections
— Sinovac says its COVID-19 vaccine is safe in children as young as 3 and has submitted the data to Chinese regulators
— Town in Colombian mountains uses discipline of locals, social-distancing campaign to stay virus-free
— Britain to observe moment of silence one year after lockdown was ordered
— Spain's newly homeless saw their jobs dry up or their marriages collapse in the pandemic and now live in their cars
— One Good Thing: Artist Yang Qian is channeling her memories from the height of the pandemic into artwork
— Follow AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak
———
HERE’S WHAT ELSE IS HAPPENING:
SEOUL, South Korea -- South Korean President Moon Jae-in has received his first shot of AstraZeneca’s vaccine as he plans to attend June’s Group of Seven meetings in Britain.
Moon on Tuesday received his shot at a public health office in downtown Seoul along with his wife and other presidential officials who plan to accompany him during the June 11-13 meetings.
Moon’s office said he was feeling “comfortable” after receiving the shot and complimented the skills of a nurse who he said injected him without causing pain.
The office said Moon will likely receive his second dose sometime around mid-May.
South Korea launched its mass immunization program in February and plans to deliver the first doses to 12 million people through the first half of the year, including elders, frontline health workers and people in long-term care settings.
Officials aim to vaccinate more than 70% of the country’s 51 million population by November, which they hope would meaningfully slow the virus and reduce risks of economic and social activity.
———
ISLAMABAD — Pakistan’s foreign minister on Tuesday sought more Chinese vaccines to fight the pandemic as the nation reported 72 deaths from COVID-19 and 3,270 new cases in the past 24 hours.
Shah Mahmood Qureshi made the request during a telephone call to his Chinese counterpart Wang Yi.
According to a foreign ministry statement, Qureshi thanked Chinese leadership for wishing Pakistan’s Prime Minister Imran Khan a speedy recovery from COVID-19. Khan tested positive over the weekend.
Qureshi also thanked Beijing for promising 1.5 million doses of Chinese vaccines for Pakistan, saying it had been pivotal to protecting lives. So far, Pakistan has received 1 million of those doses.
The statement quoted Yi as reassuring Pakistan that “China will continue to firmly support Pakistan in its fight against the pandemic."
Pakistan has reported 633,741 cases among 13,935 deaths from coronavirus since last year.
———
ORLANDO, Fla. — The number of Floridians eligible for a COVID-19 vaccine expanded on Monday as the state allowed anybody age 50 and up to get the shot.
The county that is home to the state’s biggest theme parks set the bar even lower by allowing anyone age 40 and up to get an injection.
With the loosening of the qualifications, more than a third of Floridians were now eligible solely based on age.
Starting Monday, Orange County expanded the age eligibility a decade lower than the statewide requirement. Reservations were required for the drive-thru site at the Orange County Convention Center in Orlando, and 7,000 appointments were filled within 13 minutes.
In expanding the eligibility, Orange County Mayor Jerry Demings said last week there has been decreasing demand at the site. He said he had notified the state and felt he had the authority to expand eligibility in the county.
DeSantis said he had concerns about Orange County “choosing to prioritize a healthy 40-year-old” over older residents. “It’s not authorized,” said DeSantis.
But Demings said his goal was to get as many people in Orange County vaccinated. “This is about the safety of the people in this community.”