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A Busy Week

I am always bemoaning the fact that I don't have a reliable crystal ball, but maybe I found one in this article in the Atlantic. I took the time to read it, even though we've had a very busy week.

Vaccines for 5-11 year-olds

I'm sure you all know by now that the CDC/ACIP met on November 2 and did recommend Pfizer's COVID-19 vaccine for all 5 through 11 year-old children, noting that benefits clearly outweighed risks in this population. The presentations on November 2 largely mirrored what was presented the previous week at the FDA/VRBPAC meeting. This final seal of approval on FDA's EUA set in motion a flurry of activity for healthcare providers and parents to start the immunization process. Families can consult vaccines.gov to look for vaccination appointments nearby.

Less well known, the announcement also created a new round for the original trial participants. I spent much of November 3 and thereafter contacting parents of 5-11 year old children in our trial to let them know whether their child received vaccine or placebo. We then scheduled placebo recipients to come to our clinical trials unit to receive the first dose of the vaccine; we started this on November 4 and it is proceeding very well. Needless to say, this is an important and exciting time for these families who truly are the heroes we all thank for making it possible to provide vaccine to this age group. More to come in the coming months for the younger kids!

Another Oral Drug for COVID-19?

I always cringe when a pharmaceutical company announces significant new findings without releasing detailed data, but still I was happy to see Pfizer's apparent success for a new oral therapy, PF-07321332/ritonavir. A clinical trial of this agent for non-hospitalized high-risk adults with COVID-19 was halted early after a previously scheduled interim data analysis showed efficacy. In subjects who received drug or placebo within 5 days of symptom onset, the study drug group showed 6 of 607 recipients hospitalized with no deaths, versus 41/612 hospitalized and 10 deaths in the placebo group. We'll see what the FDA says about the data, but this could add to the treatment armamentarium eventually. Currently there are no pediatric trials for this agent in clinicaltrials.gov, nor any for the other oral agent, molnupiravir, that looked promising in recent reports. Molnupiravir is a ribonucleoside analog, while the Pfizer product consists of 2 protease inhibitors.

2 thoughts on “A Busy Week

  1. Michael David Schwartz

    Thank you for the link to The article in the Atlantic
    I am hoping you will opine on the following :

    Because children get some many URI illnesses , the requirement to do a PCR diagnostic test and quarantine from school until result is available continues to cause an unacceptably high incidence of school absence and stress for working parents

    Are you aware of any consideration by the CDC to allow for school attendance , at least in vaccinated children , if an in school rapid test is negative ?

    Reply
    1. Bud Wiedermann

      Excellent points as usual from Dr. Schwartz who is in practice in Pennsylvania.
      The CDC does provide guidance for K-12 schools, and the guidance was updated to reflect vaccine authorization in the 5-11 yo age group. Importantly, the guidance points to levels of disease activity, vaccination levels, and outbreaks in the community in applying the guidelines. So, the exact implementation of these guidelines is left up to state, county, school district, and other local jurisdictions. This is very appropriate since there is a lot of variation in these conditions, but this also makes it tough for healthcare providers who may be serving children from many different schools and locations. I think it is very likely that some specific guidance may come from CDC regarding vaccine coverage in schools, but I expect we will always be dealing with local variations. I hope the local jurisdictions can eventually relax some of their testing and quarantining to allow for less interruption of education.

      Reply

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