Pfizer Tests Its COVID-19 Vaccine in Children Aged 6 Months to 11 Years

The Pfizer/BioNTech COVID-19 vaccine is seeing progress on multiple fronts, including  a newly launched study in children as young as six months old, a billion-dose a year manufacturing facility that will come on stream in Germany next month and less onerous storage temperatures expected soon in the EU.

The companies have begun a clinical trial of their COVID-19 vaccine in children six months to 11 years old, with phase 1 expected to enroll 144 participants. The study will initially seek to identify the preferred dose level (10, 20 or 30 micrograms) in three age groups ― five to 11 years, two to five years and six months to two years.

Once the dose level is confirmed, the phase 2/3 portion of the study will enroll up to 4,500 participants who will receive either the vaccine or a placebo, a Pfizer spokesperson told FDAnews.

The companies previously enrolled 2,260 children ages 12 to 15 years in a phase 3 study of the vaccine (DID, Oct. 15, 2020). Data from that study “supported the rationale for our study in younger children,” the spokesperson said.

Meanwhile, the European Medicine Agency (EMA) has approved a new BioNTech plant in Germany, which is expected to manufacture 1 billion doses of the Pfizer/BioNTech vaccine a year. The first vaccine batches are set for delivery to a separate fill-and-finish facility in the second half of April.

In other vaccine news from Europe, the agency has authorized a new AstraZeneca production site in Leiden, The Netherlands, and has recommended approval of a new Moderna plant that produces the active substance and finished product intermediates for that company’s vaccine.

In another significant advance for the Pfizer/BioNTech vaccine, the EMA has said that it may be stored at normal freezer temperatures for two weeks instead of being held at ultra-cold temperatures. The EMA has recommended — and the European Commission is expected to approve — that vials can be shipped and stored at -13 to 5 degrees Fahrenheit (-25 to -15 degrees Celsius) for up to two weeks, a move the will ease the distribution challenges posed by the ultra-cold holding requirement. The initial holding requirement was for temperatures between -130 and -76 degrees Fahrenheit (-90 to -60 degrees Celsius).

The FDA authorized the same revision to the product’s storage temperatures last month (DID, Feb. 26. ― Jason Scott