The Food and Drug Administration is worried about the toll of Omicron variant on kids
A six-year-old girl gets the Pfizer Covid-19 vaccine in San Francisco. Pic/Getty Images
Covid-19 vaccinations for children under five hit another month-long delay as US regulators abruptly put the brakes on their efforts to speed review of the shots that Pfizer is testing for youngsters. The Food and Drug Administration, worried about the Omicron variant’s toll on kids, had taken the extraordinary step of urging Pfizer to apply for okay of the extra-low dose vaccine before it’s clear if tots will need two shots or three. The agency’s plan could have allowed vaccinations to begin within weeks.
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But the FDA reversed course and said it had become clear the agency needed to wait for data on how well a third shot works for the youngest age group. Pfizer said in a statement that it expected the data by early April. FDA’s vaccine chief Dr Peter Marks said he hoped parents would understand that the agency’s decision was part of its careful scientific review of the evidence Pfizer has submitted so far.
That information “made us realise that we needed to see data from a third dose from the ongoing trial in order to make a determination,” Marks told reporters. “We take our responsibility for reviewing these vaccines very seriously because we’re parents as well.” The nation’s 18 million children under five make up the only age group not yet eligible for vaccination.
China grants approval for Pfizer’s oral pill
China’s drug regulator has granted conditional approval for the imports of Pfizer’s Paxlovid Covid-19 pill. The pill is a small-molecule oral drug, a co-package of antiviral drugs nirmatrelvir tablets and ritonavir tablets, for adults who are experiencing mild to moderate Covid-19 symptoms and who are at a higher risk of becoming more seriously ill. China’s National Medical Products Administration said the pill can be given to patients who are old or have chronic renal diseases, diabetes, cardiovascular diseases, and chronic lung diseases.
40,97,87,378
Total number of cases worldwide as of Saturday
58,23,735
Total no. of deaths worldwide
33,00,46,158
Patients recovered worldwide as of Saturday
18M
Number of children under the age of five in US
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