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 Image
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
Population perspective: In a health crisis, w/ deaths & hospitalizations spiraling, & vaccine scarcity, it's plausible delaying 2nd shots or halving doses could confer immunity on a larger pop, reducing chains of transmission. The UK is allowing 3-month intervals between doses.
Even though any given indiv will likely have less protection, a single dose dose confer some immunity. If more people can get even partial protection, it could save more lives overall. That is the thinking in the UK & elsewhere.
Where do I stand? While I usually see problems from a pop perspective, here I would stick w/ the science. It is taking a risk to deviate from the clinical trials. Also, by doing so, it would reduce public trust in the vaccine, which is vital.
There is no reason in a nation w/ such high capacities as the US that we can't produce more doses rapidly & invest in infrastructure to actually get the vaccine in people's arms. That is @JoeBiden's plan.
Should a delayed or diluted dose strategy be deployed in LMICs? It would seem inequitable if rich countries were better protected than poorer ones. I would look to @WHO to advise on dosing strategy as part of its pre-qualification process.
Overall, here's the goal:
* Produce ample vaccine supplies for the world
* Invest in vaccine infrastructure- robust health systems
* Make vaccines accessible & affordable for all
* Stick w/ the science
* Conduct clinical trials w/ different dosing strategies
* Learn & Protect

• • •

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More from @LawrenceGostin

4 Jan
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?

Daniel Salmon, @ProfHeidiLarson, and I answer in

@JAMA_current:

jamanetwork.com/journals/jama/… Image
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.
Read 5 tweets
16 Nov 20
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 Image
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.
Read 7 tweets
2 Nov 20
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.
Read 6 tweets
7 Oct 20
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
Read 10 tweets
6 Oct 20
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.
Read 4 tweets
5 Oct 20
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.
Read 6 tweets

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