France, the FDA and young kids

1. Good news from France. You may recall that France was a bit slow out of the gate getting their population vaccinated, but they picked up speed and now an estimated 90% of the adult population is vaccinated. They are reaping the benefits of this achievement with rapidly declining rates of hospitalizations and deaths from Covid. The current rate is 10 cases per 100,000 persons per day and 7,200 new cases per day. (Compare that with a rate of 45 cases per 100,000 in the U.S. and 150,000 new cases per day.) The secret to France’s success? A government mandate passed in July by President Macron and the parliament that everyone needs to get vaccinated or have a negative test in order to obtain the “pass sanitaire”. This pass is required for restaurants, stores, sports stadiums, other venues and domestic travel. France will not even allow a customer to buy a cup of coffee and sit outside at a café without showing their pass. They scan the QR code from your phone to validate your vaccination status. French healthcare workers, military and firefighters must be vaccinated or face suspension. Schools have remained open and the French economy is predicted to grow by 6.1% this year. France plans to relax mask and other restrictions in areas of lowest case rates first and then on a rolling basis. This is a heartening example of a country that made positive policy changes resulting in dramatic reductions in Covid infections and an updraft for the entire economy.

 2. Why did the FDA advisory panel do what it did? Last week the FDA advisory panel advised that booster shots be made available to those aged 65 and older and those with compromised immune systems. Usually, the FDA accepts the advice of its advisory panel. This was based in part on CDC released data. Their logic was based on data from Israel and the United States. We often see trends in Israel that are a few months ahead of where we are. Israel noted increasing rates of significant Covid infections resulting in hospitalizations in those with the earliest vaccination dates – in other words, with the longest time elapsed since they were vaccinated. More important than the antibody levels which are difficult to interpret, actual rates of significant Covid illness in previously vaccinated persons reflected waning immunity. We have also learned that the Moderna vaccine is holding up better for folks than the Pfizer vaccine. After 120 days, Pfizer has dropped to a 77% protection rate against hospitalization, whereas Moderna has maintained a 92% rate of protection against Covid illness severe enough to result in hospitalization. The reason for the difference between Pfizer and Moderna effectiveness is likely related to the fact that the Moderna shots have more mRNA in them than Pfizer.

 3. Promising data on 5- to 11-year-olds. Pfizer just released data on their experience with 5- to 11-year-old children in 2,268 study recipients. They used a dose 1/3 as strong as the adult dose – 10 micrograms rather than 30 micrograms. With a 2 shot series 21 days apart, they found both robust antibody responses, no serious side effects and minimal Covid illness – a home run! Specifically, there were no reported cases of myocarditis. Pfizer is asking the FDA for an emergency use authorization to allow use of the vaccine in 5- to 11-year-olds. An answer from the FDA could come as soon as the last week of October. Pfizer is also gathering data on children aged 6 months to age 5 years. This vaccine could potentially be available by the beginning of 2022. Since July, pediatric cases have spike over 240% in the U.S. underscoring the need for childhood Covid vaccination. There are 28 million children aged 5 to 11 in the U.S. In a Kaiser Family Foundation poll last month, ¼ of parents of 5 to 11-year-olds said they would vaccinate their children right away, ¼ of parents said they would not vaccinate their children and ½ of parents said they would take a wait and see approach.