1. I'm listening today to ACIP (CDC advisory committee) as it assesses the Moderna #CovidVaccine.
Moderna reports that side effects after vaccination are lower among people who had antibodies to SARS-2 at the start of the trial, ie were likely previously infected.

2. Moderna reports it has seen 3 cases of anaphylaxis in its clinical trial. 2 (including one y'day) were among people in the placebo arm.
1 case of anaphylaxis in the vax arm. But it occurred 63 days post vaccination (ie not caused by the vax); subject had a shellfish allergy.

3. Moderna says that now that it has completed studies in animals to ensure their vaccine does not seem to trigger developmental problems in pregnancy, they are "ready to consider conduct of trials in pregnant women."
Ready to consider?
Pregnant women need/deserve safety data.

4. Moderna's Jacqueline Miller says the company has heard the calls for data on the vaccine's safety in pregnant & lactating people & now that they've done the DART study (animal safety work) they are looking at trial designs to get answers. Sounds more like "we're on this."

5. Moderna's Miller said in the DART studies (developmental and reproductive toxicity trials), which they did in rats, they saw transfer of SARS-2 antibodies from the vaccinated mother to the fetal pups.

6. Moderna's Miller back to the anaphylaxis cases in their clinical trial: All resolved without treatment with epinephrine, ie without using an EpiPen.

7. People administering Pfizer's vaccine have found they can get a 6th or even 7th dose from the 5-dose vial. Moderna execs were asked if the same would be true for their vax (which comes in 10-dose vials). They don't expect extra doses, though a skilled person might get an 11th.

8. A Moderna scientist said that if people administering doses is able to draw a full 11th dose from their 10-dose vial, it is permissible to use it. #CovidVaccine

9. Moderna experts were asked if there are any data on use of their vaccine in people with cancer. Jacqueline Miller said people with known causes of immunosuppression were excluded from the trial, so, no. But they are going to do a trial with the National Cancer Institute.

10. I've said it before, but it's worth repeating. Anyone who is concerned about how quickly #CovidVaccines have been developed should listen to #ACIP meetings. Dozens of experts are kicking the tires of the Moderna data really hard. https://www.ustream.tv/channel/VWBXKBR8af4

11. There are now 4 reports of facial swelling among people who had previously had cosmetic dermal filler injections who were in the #Moderna #CovidVaccine clinical trial. I wrote a bit about this in @statnews' live blog of the @US_FDA advisory committee meeting Thursday.

12. Worth noting: Today's #ACIP meeting about #Moderna's #CovidVaccine comes at a time when 17.5M Americans have been diagnosed with #Covid19 & 314,305 Americans have been killed by the #SARSCoV2 virus.
314,305.
@washingtonpost is reporting 1 American dies every 33 seconds.

13. Next up, at 2 pm EST, will be a presentation from @CDCgov about #CovidVaccines and anaphylaxis. This will be important/interesting.

14. @CDCgov has identified 6 cases of anaphylaxis post vaccination with the Pfizer #covidvacccine. As of today, 272,000 doses have been administered in the US.

15. @CDCgov expert Tom Clark says that of 112,807 people who have received #CovidVaccine and enrolled in the VSafe surveillance system, 514 are pregnant people.

15. @CDCgov's Tom Clark says that among the anaphylaxis cases that have occurred after vaccination with the Pfizer #CovidVaccine, there doesn't appear to be any geographic clustering. Also, the 6 people did not receive vaccine from the same production lot — ie not a lot problem.

16. @CDCgov's Tom Clark said all 6 of the people who developed anaphylaxis after receiving the Pfizer #CovidVaccine were adults under the age of 65.

17. #ACIP member Grace Lee reminds the panel and listeners that the fact that the anaphylaxis cases are coming to light shows the systems set up to do safety surveillance after #Covid19 vaccination are working.

18. @CDCgov's Tom Clark said that while there are media reports that some hospitals have seen more than one case of anaphylaxis, investigations have discarded some reported events as not true cases. "There's no indication we're seeing clustering here."

19. Given that there appears to be some risk of anaphylaxis after #Covid19 vaccination, @CDCgov recommends that locations that administer vaccines have these supplies on hand.

20. In #ACIP's public comment period hearing a woman rail about #CovidVaccine AND about the fact that nursing home residents are first in line AND the fact that families aren't allowed to visit residents of nursing homes because of risk of spreading #Covid19.
Hmmm...

21. One of the #ACIP members noted that he knows people who have been vaccinated, haven't been asked to enroll in @CDCgov's surveillance program, V-Safe.
Enrollment info here: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html?permalink=E2B37319D2C1891433639959539AF72375B957CC4C463C73DF53805C3319433D

22. One of the #ACIP members reported hearing some vaccination locations are having difficulty accessing epinephrine, which they are being told they should have on hand to give #CovidVaccines because of the risk of anaphylaxis.
This is concerning.

23. #ACIP voted 11 - 0 to recommend use of #Moderna's #CovidVaccine. 3 members of the committee recused themselves because of conflict of interest.