The U.S. Food and Drug Administration said on Wednesday it plans to move quickly to add a warning about rare cases of heart inflammation in adolescents and young adults to fact sheets for the Pfizer/BioNTech and Moderna COVID-19 vaccines.
U.S. Centers for Disease Control and Prevention (CDC) advisory groups, meeting to discuss reported cases of the heart condition after vaccination, found the inflammation in adolescents and young adults is likely linked to the vaccines, but that the benefits of the shots appeared to clearly outweigh the risk.
Moderna shares closed down 4.2%, while Pfizer fell 1.4%.
Health regulators in several countries have been investigating whether the Pfizer/BioNTech and Moderna shots using new mRNA technology present a risk and, if so, how serious.
The CDC said that patients with heart inflammation following vaccination generally recover from the symptoms and do well.
The U.S. Department of Health And Human Services, joined by leading U.S. doctors groups and public health officials, put out a statement underscoring that the vaccines are safe and effective and that the heart side effect is "extremely rare."
"We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated," it said.
Doctors and hospitals have been warned by the CDC to watch for symptoms of myocarditis or pericarditis, and the FDA warning will further raise awareness.
Concerns about the more highly transmissible Delta coronavirus variant taking hold in the United States, and its impact on younger people, have added to the urgency to increase vaccinations even as the inoculation effort here has slowed considerably.
The number of Americans receiving their first dose of COVID-19 vaccine is down about 85% since peaking in mid-April, and will likely fail to meet President Joe Biden's goal to have delivered at least one shot to 70% of adults by July 4.
WARNING WARRANTED
"Based on the available data, a warning statement in the factsheets for both healthcare providers and vaccine recipients and caregivers would be warranted," FDA official Doran Fink said at the advisory committee meeting.
Fink, deputy director of the agency's vaccines division, said the FDA expects to move quickly to add the warning after the meeting concludes.
The cases of heart inflammation appear to be notably higher in the week after the second vaccine dose and in males. The CDC identified 309 hospitalizations from the heart inflammation in persons under the age of 30, of which 295 have been discharged.
Dr. Tom Shimabukuro, deputy director of the CDC's Immunization Safety Office, said in a presentation that data from one of the agency's safety monitoring systems - Vaccine Safety Datalink (VSD) – suggests a rate of 12.6 cases per million in the three weeks after the second shot in 12- to 39-year-olds.
"We're observing this in the younger age groups, mainly in people in the teens and early 20s, and observing it more in males, compared to females," Shimabukuro said. "This effect largely kind of disappears once you get into these older age groups - individuals 50 and over."
The CDC has been investigating heart inflammation cases mainly in young men for several months. The Israeli health ministry earlier this month said it saw a possible link between such cases and Pfizer's COVID-19 vaccine.
The CDC said it was still assessing the risk from the condition and did not specifically confirm a causal relationship between the vaccines and the heart issue.
It did, however, say that a much-higher-than expected number of young men between the ages of 12 and 24 have experienced heart inflammation after their second vaccine dose.
According to data from the U.S. Vaccine Adverse Event Reporting System (VAERS), there were 347 observed cases of heart inflammation in the week after the second vaccine dose in males aged 12 to 24. That compares with expectations of 12 or fewer cases for males in that age range based on U.S. population background incidence rates, the CDC said.
Pfizer, whose vaccine has been authorized for use in Americans as young as 12, previously said it had not observed a higher rate of heart inflammation than would normally be expected in the general population.
Moderna said it is aware of reports of heart inflammation cases following administration of mRNA vaccines. It said it is working with public health and regulatory authorities to assess the issue.
Over 138 million Americans have so far been fully vaccinated with one of the two mRNA vaccines, according to CDC data as of Monday.
Reuters
Thu Jun 24 2021
Health regulators in several countries have been investigating whether the Pfizer/BioNTech and Moderna shots using new mRNA technology present a risk and, if so, how serious. Filepic/BERNAMA
Iran's supreme leader says Hamas leader's death will not halt 'Axis of Resistance'
The "Axis of Resistance", built up with years of Iranian support, includes Hamas, the Lebanese Hezbollah group, the Houthi movement in Yemen, and various Shi'ite groups in Iraq and Syria.
Putin says Russia willing to seek compromises between Iran and Israel
Russia is ready to help seek compromises between arch-foes Israel and Iran, President Vladimir Putin said on Friday, saying these would be difficult but possible.
What proposals will Russia push at the BRICS summit?
The proposal is also to establish a BRICS reinsurance company to allow uninterrupted shipment of goods and key commodities between members.
Indonesia's free meals plan in the spotlight as Prabowo readies for office
Prabowo calls the programme one of the main drivers of economic growth, eventually set to add an estimated 2.5 million jobs.
Astro AWANI's revamped English news website, AWANI International, launches on Oct 21
Astro AWANI's revamped English platform delivers in-depth global news and expert analysis to keep you informed on key developments.
Israeli strikes kill 33 people in Jabalia refugee camp in Gaza, medics say
Residents of Jabalia said Israeli tanks had reached the heart of the camp after pushing through suburbs and residential districts.
Liam Payne's ex-partner calls for media restraint after 'painful' death
Cheryl Tweedy used her statement to urge the media to remember they had a seven-year-old son, Bear, who could read the reports.
Analysts: Indonesia's strong MoF leadership team to boost investor confidence
Sri Mulyani Indrawati as head of Indonesia's Ministry of Finance is expected to instil confidence among investors.
Biden offers both a carrot and a stick to Israel as his term nears an end
Israel has frequently resisted US advice and has caused political difficulties for the Biden administration.
Putin says BRICS will generate most of global economic growth
Russian President Vladimir Putin will host a summit of the group in the city of Kazan on Oct. 22-24.
ISIS Malaysia's perspective of Budget 2025
An excellent rakyat-centric budget under the overarching principle of a caring and humane economy.
Budget 2025: Record increase in STR, SARA aid initiatives
The government will provide a significant boost to the Sumbangan Tunai Rahmah (STR) and Sumbangan Asas Rahmah (SARA) initiatives next year.
Budget 2025: EPF contributions to be made mandatory for foreign workers – PM Anwar
The government plans to make it compulsory for all non-citizen workers to contribute to the Employees Provident Fund (EPF).
What policies to expect from Indonesia's new President Prabowo
Prabowo will be open to foreign investment, his aide has said, such as by offering investors management of airports and sea ports.
Budget 2025: Govt allocates RM470 mil to empower women's participation in PMKS
The Women's Leadership Apprenticeship Program will be intensified as an effort to produce more female corporate personalities.
Israel sends more troops into north Gaza, deepens raid
Residents of Jabalia in northern Gaza said Israeli tanks had reached the heart of the camp, using heavy air and ground fire.
Indonesia ramps up security ahead of Prabowo's inauguration
Prabowo Subianto will be sworn in as Indonesia's president on Sunday with Vice President-elect, Gibran Rakabuming Raka, also taking office.
Immediate allocation of RM150 mil for local authorities, DID to tackle flash floods
Datuk Seri Anwar Ibrahim said this allocation is intended to address the recent flash floods that hit the capital and several major towns.
Budget 2025: Sabah, Sarawak to continue receiving among highest allocations - PM
Sabah and Sarawak continues to be prioritised under Budget 2025, with allocations of RM6.7 billion and RM5.9 billion respectively.
NFOF will be operational in November 2024 with funding of RM1 bil
PM Anwar Ibrahim said NFOF will support venture capital fund managers to invest in startup companies with RM300 million set aside for 2025.