With #COVID19vaccine roll out, there is intense interest in high coverage, even w/ public distrust. Would vaccine mandates be lawful and ethical, and could they boost vaccine uptake?
For starters, mandating vaccines under Emergency Use Authorization (EUA) is legally and ethically problematic. Less safety and efficacy data mean that people are more likely to distrust such mandates.
Instead, we must consider Biologics License Application (BLA) approval, which has a higher threshold, and how mandates could be imposed across different sectors. For example, health care facilities have an ethical and legal duty to keep their staff and patients safe.
Because businesses are obligated to safeguard their customers, it’s possible that ones in high-risk settings could require proof of vaccination as a condition of service. Local or state governments could do the same, but their unlikely to mandate adult vaccines.
While #COVID19 vaccine mandates would help achieve community immunity, they could also undermine public support.
What we should consider are limited vaccine mandates with public support and longer-term safety data to return society to pre-pandemic life.
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This Thread explains the controversy around delayed 2nd doses of #Covid19vaccines or lowering the amount in each dose. The debate really boils down to what science tells us about maximum protection for INDIVIDUALS versus maximum protection for POPULATIONS. US is individualistic
Individual perspective: The clinical trials were designed to give a specified vaccine dose to "prime" the immune system, followed by a second dose 2-3 weeks later. Using this 2-dose, set interval, strategy conferred near 95% efficacy for @pfizer & @moderna_tx vaccines.
The clinical trials cannot give any assurance of high efficacy & durability of immunity with any deviation from this 2-dose, set-interval, strategy. Thus, the science requires using clinical trial data for dosing as the only sure way to confer maximum immunity for indiv patients
94% efficacy of @moderna_tx vaccine at interim analysis of 95 events is stunning. Offers realistic prospect of the beginning of the end of #COVID19 pandemic. Efficacy high enough to eliminate (not eradicate) #SARSCoV2. Comparable to measles vaccine. Don't pop the champagne yet 1X
Having 2 vaccines will boost supplies, but adds layer of complexity. Having 2 Ebola vaccines in DRC actually caused huge public fights & public confusion. We don't know which #covid vaccine is better & on which pops. We need studies comparing efficacy & risk profiles of vaccines.
Both @moderna_tx & @pfizer vaccines are new mRNA technologies so never before used widely. If effective, it could revolutionize vaccine development. Both vaccines need 2-doses, so tracking & reminder systems will be key.
Trump's hint he will fire #fauci is unlawful, unethical, & politically self-destructive. What's more, it would be a nightmare for the nation's public health agencies & for science itself. Here's why. 1X
The president has vast powers over executive agencies. But Tony Fauci is not a political appointee. In fact, he has been offered the head of @NIH & turned it down. He is a dedicated & decorated career government scientist. Trump is not his boss. @NIHDirector oversees NIH staff.
I know both Tony Fauci & Francis Collins. I am 100% sure Dr. Collins would never fire Dr. Fauci. The @NIHDirector serves at the pleasure of the President, so Trump could fire Collins & appoint a "yes man." Even then the @NIHDirector must be confirmed by the Senate.
Having worked w/ @CDCgov & ph law for 30 years, I'm deeply concerned that @CDCgov & @DistrictofC ph are being pushed aside in investigating major #COVID19 clusters at the @WhiteHouse. The @WhiteHouse is a public health & ethics free zone. It is lawless. Why? See this thread 1/X
Let's start w/ an analogy that seems over the top. Suppose the president assaulted a staffer in the @WhiteHouse. DC law enforcement doesn't have jurisdiction. What if @POTUS directed @FBI to stand down? Lawlessness, right? But that's not the same as #COVID transmission. Wrong!
Knowingly exposing others to #SARSCoV2 w/ ongoing transmission would produce even greater harm. @CDCgov has core expertise to trace contacts, find patient zero, save lives. But @Potus freezes CDC out. Stand down. DC health can't protect the public b/c it can't access @WhiteHouse
Trump physicians are citing HIPAA Privacy Rule for w/holding key med info. Wrong on many levels. Yes, HIPAA could legally apply. But here's 3 major reasons why HIPAA cannot justify utter failure to be honest & transparent on the presiden'ts health.
1) The president is the chief executive w/ const'l duties. His health impacts our national security. The public has the right to know his condition honestly & in full. Right now we are being kept in the dark about key facts concerning his health & ability to govern.
2) HIPPA has a ph exception b/c ph officials need medical info to protect the public. PH agencies need to know when he tested #SarsCoV2 positive, when he was (or still is) infectious. They must know with whom he's been in contact. All needed for tracing, quarantine & isolation.
Should Trump return to @WhiteHouse? Yes, but only if he is fully cleared by Walter Reed treating physicians to return home. He should not leave against medical advice even if his own personal physician approves it. Why? See my thread. 1/X
The president should follow the advice treating physicians at Walter Reed because they are independent & experienced. The president's physicians, as we have seen, feel under pressure to present an "upbeat" picture even if unwarranted by clinical facts. It wouldn't be safe.
If the president returns to the @WhiteHouse he must self-isolate. @CDCgov recs isolation at least 10 days since symptoms first appeared & 24 hours w/o fever. Because Mr Trump was hospitalized & needed oxygen, he may need to isolate up to 20 days.