Pfizer urges vaccine for young teens
Drug giant Pfizer and its partner in developing the first Covid-19 vaccine that received emergency authorisation in the US want to allow more adolescents to receive the vaccine.
New York-based Pfizer and BioNTech SE of Germany have asked the US Food and Drug Administration to expand the emergency use authorisation for their vaccine to include adolescents ages 12 through 15. Back in midDecember, the two-dose shot received emergency clearance for vaccinating people ages 16 and up.
Pfizer and BioNTech said they are working closely with the FDA and regulators in other countries to get emergency or conditional authorisation as quickly as possible for youth ages 12 through 15.
The companies noted in a statement that preliminary results through March 31 from late-stage testing in that age group found the vaccine safe and 100 per cent effective in blocking infections. They said side effects were consistent with those from testing of volunteers ages 16 through 25: pain and swelling at the injection site, fatigue, headaches, fever and nausea.
All participants in the study of 12 through 15-year-old volunteers will be monitored for two years, starting after they received their second dose, to watch for any safety issues and determine how long the vaccine protects recipients.
Meanwhile, European regulators are reviewing Johnson & Johnson’s Covid-19 vaccine for unusual blood clots similar to the possible risk from another vaccine, the one made by AstraZeneca.
Earlier last week, the European Medicines Agency cited a possible link between the AstraZeneca vaccine and a rare clotting disorder. The J&J vaccine is made with a similar technology, prompting questions about the possibility of similar side effects.
The European group said that it is investigating four reports of unusual clots, one in a J&J study and the others during the US rollout of the one-dose vaccine.
Before clearing the J&J shot for US use, the Food and Drug Administration investigated the clot that occurred during testing. At the time, the FDA said it would monitor for any red flags as the vaccine was used more widely.
Earlier during the week, the European regulators said there have been three additional US reports of clots with ‘‘some similarities,’’ out of almost 5 million vaccine recipients.
The EMA reiterated that it was not clear if the small number of J&J reports were linked to the vaccine, which is expected to roll out in Europe in a few weeks.