Results for “AstraZeneca”
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What I’ve been reading

1. Sarah Gilbert and Catherine Green, The Vaxxers: The Inside Story of the Oxford AstraZeneca Vaccine and the Race Against the Virus.  Self-recommending (they were leaders on the team), most of all it is striking how much time they spend covering and complaining about problems in the science funding network.  Let’s improve that.  In any case I enjoyed the book.

2. Harald Jähner, Aftermath: Life in the Fallout of the Third Reich, 1945-55.  A quite interesting book which considers how German women were disappointed in German men, how eastern German women dealt with Soviet soldier rape, how the Soviets resumed classical orchestral concerts within weeks (for their own pleasure), currency conversion, and more: “But Beate Uhse fell foul of the law for the first time, not because of violation of the moral code of corrupting the young, but for breach of price regluations.”

3. Jeevan Vasagar, Lion City: Singapore and the Invention of Modern Asia.  Selective rather than comprehensive, but entertaining and balanced and insightful.  Those interested in Singapore should read this book, and even Singapore experts will learn some new nuggets.  The author was the FT correspondent in Singapore from 2015 to 2017.

4. Mathilde Fasting and Øystein Sørensen, The Norwegian Exception: Norway’s Liberal Democracy Since 1814.  “This book started as an idea to explain Norwegian society to a broader public.”  I am not sure they quite succeed, but still it is the best single Norway book I know.  I hadn’t known for instance that Norway has two different official written languages.  In general there should be more books trying to explain highly successful countries!  This is a move in the right direction, and I am happy to see that the authors do not try to deny or run away from Norway’s first-rate performance.

5. James Hawes, The Shortest History of England.  One can pick nits with books such as these, but I found this one useful.  It stresses the role of the French in English history, and also the ongoing clash between the South and the North over who will rule whom.

There is also Robert Wuthnow’s Why Religion is Good for American Democracy (true), and Michael Taylor’s The Interest: How the British Establishment Resisted the Abolition of Slavery, which dashed my hopes when I learnt that Alexander McDonnell, the Belfast-born 19th century chess player who famously sparred with Louis de la Bourdonnais, also was a strongly pro-slavery and pro-imperialism economist in his time.

Why the defenses of Australia do not persuade me

Alex laid out some complaints about Covid policy down under, I have been receiving emails and tweets arguing the following:

1. Australia is choosing a perfectly acceptable point on the liberty vs. safety frontier.

2. The Australian decision to do extreme lockdowns is democratic, and most Australians support it.

And sometimes I see a third point, which as far as I can tell is true:

3. Australia doesn’t have much in the way of ICU excess capacity, so a Covid surge would hit the country especially hard.

I think those responses, however, are missing the point of the critique.  I would stress that if Covid risk has you with your back against the wall and the government is forcing extremely restrictive measures on your citizenry, you should be implementing the following in an urgent manner:

a. Twice a week rapid antigen tests for everyone.  (Plenty of time to prep for this one.)

b. Much stronger incentives to vaccinate people more rapidly, including with the large stock (six million or so?) of AstraZeneca vaccines.  Demand side incentives, supply side incentives, whatever can be done.  Let’s throw the kitchen sink at this one.  But as it stands, I just don’t see the urgency.

c. Mobile monoclonal antibody units, as they are used in Florida (modest progress here).

d. Maybe other emergency measures too?  I’ve been hearing for decades that Australia has such a great health care system so surely they can make lots of progress on these and other fronts?

As far as I can tell from this great distance, Australia is doing none of these.  And, while there is some disquiet about lockdowns, few of its citizens are demanding that they do any of those positive measures.  Not many of its well-known politicians are proposing those ideas either.  (Please feel free to correct me if that is wrong!…but I just don’t see word of it on-line.)

If Australia implemented all of those policies, or even just one of them, they could attain a much better “liberty vs. lives” frontier, no matter where you think the government should end up on that frontier.  They could save lives, and enjoy more liberty.

And that is the great shame and indeed I would say crime.  There seems to be an incredible complacency that people in some parts of the country will put up with the current measures and not demand the government look for more practical measures to boost both liberty and security.

So when you write me and suggest “this is democratic and the people approve,” yes that is exactly the problem.

Authoritarian Australia

Australia is now one of the most authoritarian states in the world. Conor Friedersdorf writes:

Australia is undoubtedly a democracy, with multiple political parties, regular elections, and the peaceful transfer of power. But if a country indefinitely forbids its own citizens from leaving its borders, strands tens of thousands of its citizens abroad, puts strict rules on intrastate travel, prohibits citizens from leaving home without an excuse from an official government list, mandates masks even when people are outdoors and socially distanced, deploys the military to enforce those rules, bans protest, and arrests and fines dissenters, is that country still a liberal democracy?

As I noted earlier, Australia is in clear contravention of the UN Declaration of Human Rights, Article 13 of which states:

  1. Everyone has the right to freedom of movement and residence within the borders of each state.
  2. Everyone has the right to leave any country, including his own, and to return to his country.

Friedersdorf continues:

To give Australia’s approach its due, temporary restrictions on liberty were far more defensible early in the pandemic…Had it behaved rationally and adequately valued liberty, a rich nation like Australia would have spent lavishly—before knowing which vaccines would turn out to be most effective—to secure an adequate supply of many options for its people. It could afford to eat the cost of any extra doses and donate them to poorer countries. Australia then could have marshaled its military and civil society to vaccinate the nation as quickly as possible, lifted restrictions more fully than Europe and the United States did, and argued that the combination of fewer deaths and the more rapid return to normalcy made their approach a net win.

Instead, Australia invested inadequately in vaccines and, once it acquired doses, was too slow to get them into arms. “Of the 16 million doses of the AstraZeneca vaccine that have been released to the government by manufacturer CSL, only about 8 million have gone into the arms of Australians,” The Age reported on August 21, citing concern about blood clots and a widespread preference for the Pfizer vaccine.

…Because of its geography, Australia is a neighbor and an observer of authoritarian countries as varied as China and Singapore. But its own fate, too, may turn on whether its people crave the feeling of safety and security that orders from the top confer, or whether they want to be free.

Australians largely support the restrictions but to me that makes them all the more disturbing.

Temporary restrictions on liberty can be justified in an emergency if the restrictions produce something else of great value but respecting the great value of liberty and individual rights means doing everything in one’s power to limit the scope of and lift such restrictions as quickly and completely as possible.

Thursday assorted links

1. Vaccination rates and air travel are not correlated as they should be.

2. If I understand this correctly, UT Austin professors are now free to pay students to wear masks in their classes.  Many are outraged.

3. South Australia Trials App To Monitor Quarantine Compliance Through Facial Recognition and Geolocation.  And New South Wales update.

4. Truly amazing that Australia is just sitting on six million doses of AstraZeneca [Covishield] — it might be the most effective vaccine right now!

5. The rhetoric here is not entirely safe for work, but the piece is about the behavioral economics of the cam sector.  Startlingly good.  And Alex’s earlier post.

6. Will rural America see a lot of rapid change soon?

7. Corporate America’s $50 billion vow — surprisingly good feature story, requires only a modicum of Straussian reading.

8. Why the press is (sort of) hawkish on Afghanistan (Bloomberg).

More on Australia, from an MR reader

“A random observation, in four sentences:

  1. I continue to see huge numbers of Australians (e.g. politicians like Dan Andrews, the Victorian Premier, and also huge numbers of random people on my facebook) say “if we don’t continue to lockdown, the health system will be overwhelmed; we have no choice”.
  2. Most of the at-risk population in Australia has already been vaccinated with at least one dose, which reduces hospitalisation/mortality risk by something like 70% (or perhaps even better in practice; the SMH today reports 94 people in ICU, 83 unvaccinated, 11 have one dose, and ~50% of adults have 1 dose and obviously are very negatively selected on age)
  3. The US never saw widespread overwhelming of the hospital system (lots of media reports of “hospitals in X about to hit capacity”, but it to date has always been one of those “just wait two weeks” things)
  4. People in Australia widely believe the quality of the US hospital/healthcare system is substantially inferior to the single payer hospital/healthcare system in Australia

It would seem extremely difficult for these four things to mutually coexist.”

TC again: Here is a short video from Australia, how about some AstraZeneca and a bit of testing regime instead?  GG is right that the video resembles a bad dystopian science fiction movie from past decades.  You will note that some segments of the American intelligentsia are so invested in criticizing the U.S. “red state” approach, and so warm toward collectivist mandates, that they won’t raise a peep about what is going on here.

The problem with fitting third doses into a regulatory structure

That is a key theme of my latest Bloomberg column, here is one excerpt:

In the U.S., President Joe Biden’s administration is now pushing third booster shots for people who already have been vaccinated. That might be a good idea, but it too creates additional uncertainty for travel and migration — and for social interaction more broadly. If three doses are so important, should people be allowed to travel (or for that matter interact indoors) with only two doses? The bar is raised yet again.

Of course the issues do not end with the third dose. If the efficacy of the second dose declines significantly in less than a year, might the same happen with the third dose? How long before four doses are necessary, or maybe five? Or what if yet another significant Covid variant comes along, and only some people have a booster dose against that strain? What then counts as being “sufficiently vaccinated”?

Many Americans seem to be keen to get their third dose, but by the nature of counting that number is fewer than the number willing to get two doses. Furthermore, many people might just tire of the stress of dealing with an ongoing stream of obligatory booster shots and stop at one or two.

The sad reality is that the “two-dose standard” may not last very long, whether abroad or domestically (the same is true of the even weaker one-dose standard with Johnson & Johnson and AstraZeneca). Vaccine mandates will become harder to define and enforce, will be less transparent, and will probably be less popular.

If you tell people that three doses are needed for safety, but two doses are enough to get you into a concert or government building, how are they supposed to sort out the mixed messages? It is not obvious that enough people will get the third dose in a timely manner to make that a workable standard for vaccine passports.

Add to that the problems with the Johnson & Johnson vaccine, which originally the government urged people to get. Now those people are not being given comparable chances to obtain boosters — in fact, they are not yet being given specific guidance at all. Are they orphaned out of any new vaccine passport system, or will (supposedly dangerous?) exceptions be made for them? Or do they just have to start all over?

The big international winner from all this is likely to be Mexico, which has remained an open country and is not relying on vaccine passports. In general I do not admire Mexico’s lackadaisical Covid response, but the country may end up in a relatively favorable position, most of all when it comes to tourism and international business meetings.

As for the U.S. and Europe, the temptation to escalate required safety measures is understandable. But the previous vaccine standards were largely workable ones. If they are made tougher, they might break down altogether.

Recommended.

Sunday assorted links

1. “Why is violence so prevalent in kitchens, and how has it become a behavioral norm?

2. Meng Wanzhou update.

3. I really don’t view MR or links as a chance to dunk on people, but this is so, so wrong, and so indicative of the problems with public health “experts.”  More here.  That is an example, and in my view an instructive one, but really not interested in making this about any particular person.  It was in turn taught by someone else, and it is believed by many in the field.  The actual reality is that even very poorly educated Americans, on the whole, hold more sensible views than that.

4. Michael Mina from November 2020.  Not bad.

5. Dishonest dishonesty study study.

6. “They shoot dogs, don’t they?”  Or try this short video.  And the AstraZeneca stockpile continues to grow.  Why are the defenders of civil liberties so quiet?

7. The difficulty in getting hospitals to post their prices (NYT).

Saturday assorted links

1. “The first vaccination data from the Neptune Declaration Crew Change Indicator shows that only 15.3% of seafarers are vaccinated.

2. New IMF working paper “Mask Mandates Save Lives,” note pre-Delta.

3. People who have been working two jobs from home (WSJ): “The money is incredible, the 29-year-old software engineer says. So is the stress: “I’ll wake up in the morning and I’m like, ‘Oh, this is the day I’m gonna get found out.’ ”

4. Those new (and temporary) service sector jobs.  And circa 2020, NYT publishes Op-Ed from the Taliban, outlining what they in fact want.

5. More on Paul Samuelson’s very bad macroeconomics.

6. A high-placed Delta Straussian.

The TGA is Worse than the FDA, and the Australian Lockdown

I have been highly critical of the FDA but in Australia the FDA is almost a model to be emulated. Steven Hamilton and Richard Holden do not mince words:

At the end of 2020, as vaccines were rolling out en masse in the Northern Hemisphere, the TGA [Therapeutic Goods Administration, AT] flatly refused to issue the emergency authorisations other regulators did. As a result, the TGA didn’t approve the Pfizer vaccine until January 25, more than six weeks after the US Food and Drug Administration (FDA), itself not exactly the poster child of expeditiousness.

Similarly, the TGA didn’t approve the AstraZeneca vaccine until February 16, almost seven weeks after the UK.

In case you’re wondering “what difference does six weeks make?“, think again. Were our rollout six weeks faster, the current Sydney outbreak would likely never have exploded, saving many lives and livelihoods. In the face of an exponentially spreading virus that has become twice as infectious, six weeks is an eternity. And, indeed, nothing has changed. The TGA approved the Moderna vaccine this week, eight months after the FDA.

It approved looser cold storage requirements for the Pfizer vaccine, which would allow the vaccine to be more widely distributed and reduce wastage, on April 8, six weeks after the FDA. And it approved the Pfizer vaccine for use by 12 to 15-year-olds on July 23, more than 10 weeks after the FDA.

And then there’s the TGA’s staggering decision not to approve in-home rapid tests over reliability concerns despite their widespread approval and use overseas.

Where’s the approval of the mix-and-match vaccine regimen, used to great effect in Canada, where AstraZeneca is combined with Pfizer to expand supply and increase efficacy? Where’s the guidance for those who’ve received two doses of AstraZeneca that they’ll be able to receive a Pfizer booster later?

In the aftermath of the pandemic, when almost all of us should be fully vaccinated,there will be ample opportunity to figure out exactly who is to blame for what.

But the slow, insular, and excessively cautious advice of our medical regulatory complex, which comprehensively failed to grasp the massive consequences of delay and inaction, must be right at the top of that list.

You might be tempted to argued that the TGA can afford to take its time since COVID hasn’t been as bad in Australia as in the United States but that would be to ignore the costs of the Australian lockdown.

Article 13 of the Universal Declaration of Human Rights states that

  1. Everyone has the right to freedom of movement and residence within the borders of each state.
  2. Everyone has the right to leave any country, including his own, and to return to his country.

Australia has now violated each and every clause of this universal human right and seemingly without much debate or objection. It is deeply troubling to see people prevented from leaving or entering their own country and soldiers in the street making sure people do not travel beyond a perimeter surrounding their homes. The costs of lockdown are very high and thus so is any delay in ending these unprecedented infringements on liberty.

The Most Important Act of the Last Two Decades?

A good case can be made that Project Bioshield is the most important piece of legislation passed in the last twenty years. Passed under President Bush in 2004, Project Bioshield’s primary goal was to create advance market commitments to purchase countermeasures for chemical, biological, radiological or nuclear agents (CBRN). Several billion dollars have been spent in this area promoting anthrax and smallpox vaccines and various antitoxins for botulism and nuclear threats. The record on these advance market commitments is mixed with some notable failures.

The second thing the act did is to reduce some paperwork requirements on purchases and research funding. Those seem fine although the simplified procedure is itself too complex and the amounts such simplified procedures apply to are too small, e.g.

The Project Bioshield Act authorizes the HHS Secretary to use an expedited award process for grants, contracts, and cooperative agreements related to CBRN countermeasure R&D Activity, if the Secretary deems a pressing need for an expedited award exists. The authority is limited to awards of $1.5 million or less.

The third aspect of the act was not considered a big deal at the time but is the one that has proved to be the most important. Project Bioshield created the Emergency Use Authorization (EUA). In other words, prior to 2004 the FDA had no clear legislative authority to authorize an unapproved vaccine, drug or device. Without Project Bioshield and the EUA procedure the FDA might have eventually found some way to authorize vaccines before full approval. Britain, for example, used a temporary authorization procedure. Or the FDA might have sped up full approval but given the FDA’s lethargic record it’s easy to imagine that this would have taken months longer than the EUA process. As a result, the EUA procedure created by Project Bioshield probably saved 100,000 or more lives.

Important Addendum: It’s also worth mentioning that the EUA procedure doesn’t just apply to approvals it also allows changes in dosage and labeling. Susan Sherman, the senior attorney with the HHS Office of the General Counsel, noted in 2009 that a drug that had been approved for individual health in a non-emergency might have to be used very differently for public health in an emergency and that the EUA process could be used to adjust to these differences:

“You can change the labeling. You can change the information. You can change the dosage. You can give it to populations for which wasn’t approved.” She continued, “In some sense we had to match up in practice a public health response where you might not have the precise labeling that your physician would prescribe to you. There are a lot of variables that are necessary for the public health responders that don’t necessarily match what the approved drug would look like if you just went to your physician and got it because you had that illness.

In other words, the EUA process was made to allow for procedures such as fractional dosing. It’s too late for fractional dosing in the United States (but we should use it for boosters) but fractional dosing remains a vital tool to deal with the global shortage of vaccines.

Wednesday assorted links

1. Renderings of large, extinct animals.

2. Rank size of a minority group matters for hate crime.

3. Is adolescent loneliness rising?

4. Good Klein-Douthat dialogue.  By the way, here is Ross’s forthcoming book The Deep Places: A Memoir of Illness and Discovery.

5. NFTs update (NYT).  To make your head spin: “One issue that has not caught up with the technology is how NFTs will be taxed. Cryptocurrency is taxed at the capital gains rate, and many experts say they believe that NFTs will be considered collectibles, which are taxed at a 28 percent rate. But the tax issue gets more complicated because many NFTs are bought using cryptocurrency. So any transaction would be considered a realization of the gains in that cryptocurrency.”

6. Number of unused AstraZeneca vaccines in Australia tops 3 million.  And yet they are in effect incarcerating significant portions of their citizenry.

Use Fractional Dosing to Speed Vaccination and Save Lives

I’ve been shouting about fractional dosing since January, most recently with my post A Half Dose of Moderna is More Effective Than a Full Dose of AstraZeneca and the associated paper with Michael Kremer and co-authors. Yesterday we saw some big movement. Writing in Nature Medicine, WHO epidemiologists Benjamin Cowling and Wey Wen Lim and evolutionary biologist Sarah Cobey title a correspondence:

Fractionation of COVID-19 vaccine doses could extend limited supplies and reduce mortality.

Exactly so. They write:

Dose-finding studies indicate that fractional doses of mRNA vaccines could still elicit a robust immune response to COVID-192,3. In a non-randomized open-label phase 1/2 trial of the BNT162b2 vaccine, doses as low as one third (10 μg) of the full dose produced antibody and cellular immune responses comparable to those achieved with the full dose of 30 μg (ref. 4). Specifically, the geometric mean titer of neutralizing antibodies 21 days after the second vaccine dose was 166 for the group that received 10 μg, almost the same as the geometric mean titer of 161 for the group that received 30 μg, and 63 days after the second dose, these titers were 181 and 133, respectively4. For the mRNA-1273 vaccine, a dose of 25 μg conferred geometric mean PRNT80 titers (the inverse of the concentration of serum needed to reduce the number of plaques by 80% in a plaque reduction neutralization test) of 340 at 14 days after the second dose, compared with a value of 654 for the group that received the standard dose of 100 μg (ref. 5). According to the model proposed by Khoury et al.6, if vaccine efficacy at the full dose is 95%, a reduction in dose that led to as much as a halving in the post-vaccination geometric mean titer could still be in the range of 85–90%. Although other components of the immune response may also contribute to efficacy, these dose-finding data are at least indicative of the potential for further exploration of fractionation as a dose-sparing strategy. Durability of responses after fractional doses should also be explored.

…Concerns about the evolution of vaccine resistance have been posited as a potential drawback of dose-sparing strategies. However, vaccines that provide protection against clinical disease seem to also reduce transmission, which indicates that expanding partial vaccination coverage could reduce the incidence of infection. As described in a recent paper, lower prevalence should slow, not accelerate, the emergence and spread of new SARS-CoV-2 variants8.

…In conclusion, fractionated doses could provide a feasible solution that extends limited supplies of vaccines against COVID-19, which is a major challenge for low- and middle-income countries.

Also a new paper in preprint just showed that 1/4 doses of Moderna create a substantial and lasting immune response on par with that from natural infection.

Here we examined vaccine-specific CD4+ T cell, CD8+ T cell, binding antibody, and neutralizing antibody responses to the 25 ug Moderna mRNA-1273 vaccine over 7 months post-immunization, including multiple age groups, with a particular interest in assessing whether pre-existing crossreactive T cell memory impacts vaccine-generated immunity. Low dose (25 ug) mRNA-1273 elicited durable Spike binding antibodies comparable to that of convalescent COVID-19 cases. Vaccine-generated Spike memory CD4+ T cells 6 months post-boost were comparable in quantity and quality to COVID-19 cases, including the presence of TFH cells and IFNg-expressing cells.

Finally, an article in Reuters notes that Moderna are preparing to launch a 50 ug dose regimen as a booster and for children. Thus, contrary to some critics of our paper, the technology is ready.

Frankly, governments are way behind on this–they should have been pushing the vaccine manufacturers and funding trials on alternative dosing since at least January. Indeed, imagine how many lives we might have saved had we listened to Operation Warp Speed advisor Moncef Slaoui who advocated for half doses in January. On a world scale, we could have vaccinated tens even hundreds of millions more people by now had we ramped up fractional dosing.

At this point, it’s my view that there is enough knowledge to justify rolling out alternative dosing in any hot spot or in any country worried about outbreaks. Roll it out in a randomized fashion (as Kominers and I discussed in the context of the US vaccination rollout) to study it in real time but start the roll out now. Lives can be saved if we speed up vaccination, especially of the best vaccines we have, the mRNAs. Moderna and Pfizer have together pledged to deliver (mostly Pfizer and mostly through the US) some 250m vaccine doses to COVAX in 2021 for delivery to less developed countries. If we go to half-doses that becomes 500m doses–a life saver. And recall these points made earlier:

Judging by neutralizing antibodies, a 50 ug dose of, for example, Moderna looks to be more effective than standard dosing of many other vaccines including AZ and J&J and much better than others such as Sinovac. Thus alternative dosing is a way to *increase* the quality of vaccine for many people.

A 50 ug dose vaccine available today is much higher quality than a 100 ug dose vaccine available one year from now.

If we have the will, we can increase vaccine supply very rapidly.

More on Alternative Dosing

Some quick comments in response to questions and discussion about my paper Could Vaccine Dose Stretching Reduce COVID-19 Deaths? (written with the all-star cast of Witold Więcek, Amrita Ahuja, Michael Kremer, Alexandre Simoes Gomes, Christopher M. Snyder and Brandon Joel Tan.

1) Any method of increasing vaccine supply will require other changes in the supply chain such as more needles. We think alternative dosing can increase supply quickly with the fewest supply chain disruptions.

2) If we had started Moderna with 50 ug dosing no one would be advocating for 100 ug dosing, thereby halving supply. Rather than “full” or “half-doses,” which bias thinking, we should talk about alternative dosing and ug.

3) Judging by neutralizing antibodies, a 50 ug dose of, for example, Moderna looks to be more effective than standard dosing of many other vaccines including AZ and J&J and much better than others such as Sinovac. Thus alternative dosing is a way to *increase* the quality of vaccine for many people.

4) A 50 ug dose vaccine available today is much higher quality than a 100 ug dose vaccine available one year from now.

5) There are substantial risks from following the current approach, as India and now parts of Africa illustrate. Alternative dosing has a very large upside but small downside since we could switch back to standard doses. For example, Great Britain and Canada delayed the second dose to 12 and 16 weeks respectively but have since reduced the dosing interval as more supplies have become available.

6) The greatest risk to immune escape comes from the unvaccinated. Alternative dosing protects not only those who are dosed but by reducing transmission also reduces risks to the unvaccinated.

7) The key question we face now is not whether there are objections and complications to alternative dosing (there are) the key question is what additional information, available quickly could resolve the most uncertainty? In other words, what can we learn soon that would most aid decision makers?

See the paper for details and also my previous post, A Half Dose of Moderna is More Effective Than a Full Dose of AstraZeneca.

Addendum: It should be clear that this isn’t about the United States, it is about getting high-quality vaccine to places that have little to none.

Fractional Dosing Study in Brazil

Fiocruz, the Brazilian public health institute, will test half doses of the AstraZeneca vaccine. Not much information available yet. From a Google Translate article.

BANDNews: Fiocruz, in partnership with the government of Espírito Santo, is going to carry out a study with the application of half a dose of the Astrazeneca vaccine to the entire population of the municipality of Viana, in Greater Vitória.

The city has about 35 thousand inhabitants.

The immunization will take place on Sunday, June 13, and residents will be able to choose whether they want to participate in the study.

According to the state secretary of Health, Nésio Fernandes, there is already evidence of the effectiveness of the application of half a dose of the vaccine in immunization against Covid-19.

If the experience is successful, it will be possible to double the number of people vaccinated in the country with the immunizing agent produced by Fiocruz.

See my previous posts on fractional dosing for why this is very important.

Hat tip: Cisco Costa.

Fractional Dosing Trials Now!

Fractional dosing has the potential to massively increase the supply of COVID vaccine. The Moderna Phase I clinical trial and Pfizer Phase I/II trials already indicated a substantial immune response with smaller doses but the vaccine companies are under-incentivized to run additional fractional dosing trials (they won’t gain trillions, at best they will gains billions and might even lose some profit) and governments and private organizations are not picking up the ball. There are just two small trials underway that I am aware of:

N.B. now that we know that the vaccines work. we don’t need to study every dosage for efficacy against the virus. Instead of efficacy studies we can study how the vaccine is working in the body compared to those fully immunized, immunogencity trials (which is what the above trials are doing) and then use data and theory to infer effectiveness. If we felt it necessary to study effectiveness, human challenge trials would be ideal in this situation as you can study gradually smaller doses with little risk to the patients. But given the urgency, immunogenicity trials should provide enough information to make decisions on the ground. To limit risk, one could do a half-dose on the second dose or one could do a half-dose in people under the age of 50. Both of these regimens would still create significant increases in supply. Recall that in 2018, facing a yellow fever epidemic and a shortage of vaccine, Brazil used 1/5th doses to break the epidemic.

There are no guarantees but the world is ignoring a potential trillion dollar bill lying on the sidewalk.

Hat tip for discussion: Witold and Amrita.