US FDA delays approval for Moderna vax for teens
Moderna also said it will delay filing a request for emergency use authorisation for a smaller dose of the vaccine for younger kids aged six to 11 while the FDA completes its review.
Moderna also said it will delay filing a request for emergency use authorisation for a smaller dose of the vaccine for younger kids aged six to 11 while the FDA completes its review.
More than 7 million Americans have received a booster dose in the US as of Saturday, according to the latest data available from the CDC.
"We believe our mRNA platform can solve the world's greatest health challenges, from diseases impacting millions, to ultra-rare diseases impacting dozens, to medicines personalised down to the individual level,"
The Minister for Health and Aged Care, said the third Covid-19 vaccine added to Australia's rollout boost the vaccine plan during a tough period.
The findings showed that it induced robust antibody responses against the wildtype D614G Covid-19 strain and against important variants of concern including Gamma (P1); Beta (B1351); and Delta (B16172), the US pharmaceutical major said in a statement.
The increase in trial size will also help assess whether a rare inflammation of the heart muscle, seen in young adults shortly after vaccination, is common in younger age groups, the Washington Post reported.
"Very rare cases of myocarditis and pericarditis have been observed following vaccination with the mRNA Covid-19 vaccines. These cases occurred more often in younger men and after the second dose of the vaccine, typically within a few days after vaccination"
Lt. Gen. John Frewen said that younger Australians could be given a choice about which mRNA vaccine they receive
The vaccine produced neutralising titers against all variants tested, including versions of the Beta variant which was first identified in South Africa
The Pfizer-BioNTech shot has been approved by the US Food and Drug Administration (US FDA) and other western regulators for emergency use. The vaccine is also authorised for use in teens in the US.
