Pregnant, immune compromised and young.

We are all frustrated to some degree about the resurgence of Covid in the U.S. due to the combination of low vaccination rates and the very contagious Delta variant. Pandemics end, and this one will too!

1. ?Could to should: new guidance for pregnant women.?New data released by the CDC last week makes the guidance to pregnant women more certain: they?should?take the vaccine. Previous guidance said that pregnant women?could?take the vaccine. CDC Director, Dr. Rochelle Walensky said, “the?CDC encourages all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated to protect themselves from COVID-19.” According to the CDC, data from?three safety monitoring systems?did not find any safety concerns for pregnant women who were vaccinated late in pregnancy or for their babies. A?new CDC analysis?of current data from the v-safe pregnancy registry assessed vaccination early in pregnancy and did not find an increased risk of miscarriage among 2,500 pregnant women who received the Pfizer or Moderna vaccines before 20 weeks of pregnancy.

?Miscarriage typically occurs in about 14% of pregnancies, and this study found miscarriage rates after receiving the Pfizer or Moderna vaccine were around 13%, similar to the expected rate of miscarriage in the general population. The number of pregnant women infected with Covid has risen in the past several weeks.?The CDC concludes that, “The increased circulation of the highly contagious?Delta variant, the?low vaccine uptake among pregnant people, and the increased risk of severe illness and pregnancy complications related to Covid infection among pregnant women make vaccination for this population more urgent than ever.”

?2. Boosters for immune compromised people.?People who are moderately to severely immunocompromised make up about 3% of the adult population and are especially vulnerable to?Covid infection with worse outcomes. The data is now solid that many immune compromised people do not generate adequate antibodies against Covid after vaccination. The categories of immune compromised persons include patients with organ transplants, such as kidney, liver and heart, patients undergoing chemotherapy or with active cancer, patients on immunosuppressive drugs such as biologics and steroids, and other patients with medical conditions that may impair the immune system. In?small studies, fully vaccinated immunocompromised people have accounted for a large proportion of hospitalized “breakthrough cases.”?Data shows that a significant subset of patients with a poor initial immune response to any of the vaccines, get a pretty good response to a booster vaccine. Though not yet part of the recommendation, some research shows that using a different vaccine from the initial one improves the antibody response. It should also be kept in mind that antibody levels can be measured, but it is hard to know what the results actually mean. It should also be kept in mind that part of the immunity conferred to us by all of the vaccines include T-cells that reside in the bone marrow and are very difficult to measure.

The third shot can be received 28 or more days after completing the Pfizer or Moderna 2-vaccine set. Unfortunately, at present there is not enough data and therefore no guidance or recommendation for those people who received the J&J vaccine. The CDC had to make some arbitrary decisions about who to include for recommendation for a third shot, or booster. Those categories which are very inclusive include the following:

• Receiving active cancer treatment for tumors or cancers of the blood
• Received an organ transplant and are taking medicine to suppress the immune system
• Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
• Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
• Advanced or untreated HIV infection
• Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

I am pleased to report that the system is very easy to navigate at the pharmacies as no doctor’s note or order is required. You simply fill out a few questions, bring your vaccine card and attest that you meet the criteria outlined above. If you initially received Pfizer you should get the Pfizer booster, and same with Moderna. However, if the one you got is not available, it is allowed to take the other one. As an aside, yesterday the federal government suggested that pending FDA approval,?all?vaccinated persons will become eligible for a third dose starting in October, eight months or more after their last dose – timelines TBD. At that time, J&J hopes to be included in a second booster dose, which would make sense.

3. What about the 5 to 11-year-olds??There are 50 million children under the age of 12 in the U.S. Current guidance suggests that an Emergency Use Authorization (EUA) to vaccinate children aged 5 to 11 will be available as early as October for Pfizer and/or Moderna. Though this is obviously not in time to prevent infection and transmission of Covid at the beginning of this school year, there is light at the end of this tunnel for most kids, parents and teachers by the end of Fall or into Winter of this year. We should not have to see a repeat of last year with extensive schooling from home for children over the age of 5 for the entire year.