FDA to decide on boosters ... soon
Idaho shifts into healthcare rationing as COVID-19 cases keep rising; US deaths on track to pass 1918 flu; over 50,000 dead in Florida
The USA is racing towards 675,000 deaths from COVID-19, passing the tally of known deaths from the 1918 influenza. The U.S. has recorded more than 666,000 deaths so far, with more than 10,000 deaths in the past week, according to the CDC.
Idaho has stepped in to a situation that no healthcare professional ever wants: rationing of care. On Thursday, state officials implemented “crisis standards of care.” This means that hospitals must treat patients based on likelihood of survival. Those who are less likely to survive might not get an ICU bed or other advanced care, because the system has exceeded its capacity.
“The situation is dire — we don’t have enough resources to adequately treat the patients in our hospitals, whether you are there for COVID-19 or a heart attack or because of a car accident,” IDHW Director Dave Jeppesen said in a news release Thursday.
Pfizer data presented Friday shows strong benefit of third dose across age groups, with few adverse events: I am writing this while listening to the Food and Drug Administration vaccine advisory committee meeting, where scientists are presenting and reviewing data on booster shots of the Pfizer-BioNTech COVID-19 vaccine. Whatever the FDA and CDC decide, the issue of boosters is not going to get any less confusing - not for awhile, at least. Here’s what you need to know:
Data presented from Israeli scientists showed that new COVID-19 cases began rising rapidly in late July, then dropped rapidly by early September after booster shots were administered.
FDA staff analysis of the Pfizer data is available at this link.
Despite evidence of “waning” vaccine efficacy after 6-8 months, the vaccines still provide substantial protection. In other words, don’t use reports about declining efficacy as reasons to avoid the vaccines in the first place.
Booster shots are not going to become widely available starting September 20, as the White House announced on August 18. Kaiser Health News has an intriguing story on how the White House got ahead of FDA on this. (Spoiler alert: there is a ton of data coming in every day from multiple sources, and the U.S. government now has a lot of scientists in different places analyzing it.)
The initial approval for booster shots likely will be only for people who received the Pfizer vaccine.
Moderna’s data has been submitted to FDA in support of a lower-dose third shot of its vaccine. The company says its vaccine loses about 1/3rd of its power after 12 months.
The number of severe adverse events (SAEs) linked to the Pfizer vaccine remains tiny. In Israel, there were four possible SAEs and no deaths after booster shots among more than 2 million booster shot recipients. Among more than 866,000 people 65 and older who got boosters, there were three possible SAEs, including one death.
The FDA advisors will vote on the Pfizer boosters later today. You can watch the meeting (live or later) on YouTube. As with other vaccine matters, next steps would be the FDA Commissioner’s decision and the CDC’s publication of guidance for clinicians.
A compilation of vaccine data, which is updated frequently, is on the CDC website. Among recent studies is a very small one showing that an mRNA vaccine given to people who received the Johnson & Johnson vaccine generates a high immune response. This is similar to studies in Europe showing the immune response after the AstraZeneca vaccine, which is similar to the J&J shot.
A few other COVID-19 items of note:
Another $2 billion has been earmarked by the White House and CDC to bolster state and local public health capabilities, including “strike teams” to respond to new outbreaks, expanded training on infectious diseases for community and other health workers, and new programs to monitor and improve antibiotic use.
CDC says antibiotics have been routinely prescribed for COVID-19, even though antibiotics are ineffective against viruses. This increases risk of new bacterial infections that become resistant to antibiotics.
The CDC updated its page guiding fully vaccinated people on everyday activity. Key points:
wear a mask if in public where new cases are rising,
get tested 3-5 days after exposure to someone with COVID-19 and wear a mask in public for 14 days or a negative test result, and
get tested 3-5 days after returning from international travel - even if you have no symptoms.
A judge in Kentucky rejected a woman’s effort to have a hospital administer ivermectin to her husband, noting that the requestor failed to provide any scientific evidence to support the request. An Ohio court went the other way on a similar case earlier in the month.
Last year we saw that obesity among American children appeared to be a factor in the higher rate of severe COVID-19 among children in the USA compared with other countries. Now, we also see that obesity among children has gotten worse during the pandemic. New data published by the CDC estimates that the rate of increasing body mass index (BMI) among 2-19 year olds has doubled during the pandemic over pre-pandemic times.
While many people are celebrating the reopening of Broadway theater in New York, COVID-19 continues to thwart in-person activities. Atlanta’s run of Hamilton was interrupted after COVID-19 cases were detected.
Many healthcare and other workers are claiming religious reasons for rejecting COVID-19 vaccinations. In contrast, the Pope urges everyone to get vaccinated, telling reporters that getting vaccinated is “an act of love.”
You may have noticed very low prices on hand sanitizer in local stores. Here’s an article on how the surprising demand for the product affected two San Francisco area companies.
Here’s to keeping safe as cold weather starts setting in.
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