Results for “astrazeneca” 93 found
Saturday assorted links
1. DNIonUFOs.
2. Florida bans pythons: ““People have literally spent millions and even moved to Florida from out of state, built cages and started businesses, and now they have to get rid of everything,” said Brian Love, a founding member of the group’s state chapter.”
3. Maps of the names of Donald Duck’s brothers in different countries.
4. “In Germany, there’s a very great reluctance to countenance imposing affirmative harm on people in trade-off situations,” Dr. Persad said. “It’s a very strong emphasis on not causing harm, even if you allow much more harm through inaction.” (NYT link)
The EU Vaccine Bungling
The EU vaccine rollout has been remarkably bungled even by the standards we have come to expect from Western governments. In advising governments I and the AHT team argued that vaccines were the world’s easiest cost-benefit test because Billions<<Trillions. Yet when manufactures offered the EU vaccines worth thousands of dollars a dose for just $5-$40 a dose the EU foolishly shouted “price gouging” and wasted weeks in dickering. I leave it to you as an exercise to calculate the value EU governments implicitly placed on European lives.
The latest bungling was the halt by over a dozen European governments of vaccination with the AstraZeneca vaccine due to fears that it might cause very rare blood clots (wisely Belgium and Great Britain continued vaccinations). After a review, the EMA has now cleared the vaccine:
The European Union’s drug regulator said on Thursday that the AstraZeneca vaccine was safe and effective, a finding that officials hope will alleviate concerns about possible rare side effects involving blood clots and allow more than a dozen countries that halted its use to add it back into their arsenal against the resurgent coronavirus.
The halt, however, was never justified. The EMA press release make this clear because it hasn’t added much more information it only underlines what we already knew. Namely, there was no increase in the overall risk of blood clots. There might be an increase in a very rare type of blood clot but that wasn’t obvious, especially when one takes into account that when you are monitoring hundreds of rare side effects it’s bound to be the case that some show statistically significant effects even if there are no true effects. As a result, the more conditions you test the higher standards you should apply to judge a difference as statistically significant (ala Bonferroni Correction which the EMA does not appear to have done). Moreover, even assuming that the rare vaccine effects were real they were thousands of times less than the effects of blood clotting from COVID itself so if you wanted to avoid blood clots the way to do so was to take the vaccine. Moreover, even assuming that the rare effects were real, they were not larger than those from other common activities such as flying or taking contraceptive pills. Moreover, and this point does not seem to have been made prominent, the most plausible argument for the vaccine creating blood clots is through the generation of the spike protein, which all the vaccines do, so there is little reason to believe that the Pfizer or Moderna vaccine would not also have the same problems (which they might). Thus, the focus on AZ seemed oddly misplaced. Draw your own conclusions on that.
The end result is that more people will die from the halt than could possible have been saved by the halt. Why did this happen? One reason is the absurd focus on doing anything to alleviate “vaccine hesitancy.” To alleviate vaccine hesitancy we have repeatedly sent the message that the vaccines are “safe, safe, safe.” When we should have said the vaccines pass a cost-benefit test (with flying colors!) and are much safer than many drugs people take for less serious conditions. But every drug or vaccine has side-effects. Tradeoffs are everywhere.
Unfortunately, vaccine hesitancy seems to have become a catch-all excuse for never having to show your work with a cost-benefit analysis. As I said in my post Don’t Delay a Vaccine to Allay Fear (should have said don’t halt one either!):
We should not let public policy be guided by the most risk averse, fearful, and scientifically illiterate among us.
[And]… rather than alleviating fear, delay may increase fear. People may reason, if the FDA is taking this long to review the evidence when thousands of people are dying every day it must be a hard decision.
The latter point, of course, is exactly what has happened. The EU halt has increased vaccine hesitancy rather than alleviating it.
Addendum:
- Feb. 2: France restricts AstraZeneca vaccine to those aged less than 65 years of age.
- March 2: France approves AZ vaccine for all ages.
- March 19: France recommends AstraZeneca vaccine only to those aged more than 55 years.
I guess 55-65 years of age is the sweet spot.
How bad is EU bungling? So bad, Paul Krugman and I are in agreement. He almost quotes me on “Progressivism: The haunting fear that someone, somewhere, may be making a profit.”
FDA Postpones Inspections Delaying New Drugs and Creating Shortages of Old Drugs
NYTimes: The Covid-19 pandemic has forced the Food and Drug Administration to postpone hundreds of drug company inspections, creating an enormous backlog that is delaying new drug approvals and leading the industry to warn of impending shortages of existing medicines.
…In an interview, F.D.A. officials said they sharply curtailed the inspections to protect their investigators, following guidelines from the Centers for Disease Control and Prevention, which discouraged federal employees from travel during the pandemic.
But some people in both industry and public health communities say that federal drug inspections are essential, and that the agency should bypass travel restrictions by taking precautions, including wearing proper personal protective equipment.
…In interviews, F.D.A. officials denied that the dramatic drop in inspections has slowed drug approvals. But a number of drug companies, including Spectrum Pharmaceuticals, Biocon Biologics and Bristol Myers Squibb, has issued statements noting deferred F.D.A. action because of the agency’s inability to conduct inspections.
In October, Spectrum announced that the F.D.A. had deferred action on its application for Rolontis, a treatment for cancer patients who have a very low number of certain white blood cells, because it could not inspect the manufacturing plant the company uses in South Korea.
In late December, Biocon Biologics notified shareholders that the F.D.A. deferred action on its joint application with Mylan for a proposed biosimilar to Avastin, a cancer drug.
Bristol Myers Squibb announced in November that the F.D.A. would miss its November deadline for taking action on a lymphoma treatment, lisocabtagene maraleucel because it could not inspect a third-party Texas manufacturing plant. The agency eventually did complete its inspection and approved the drug last month.
Grocery store workers are working, meat packers are working, hell bars and restaurants are open in many parts of the country but FDA inspectors aren’t inspecting. It boggles the mind.
Let’s review. The FDA prevented private firms from offering SARS-Cov2 tests in the crucial early weeks of the pandemic, delayed the approval of vaccines, took weeks to arrange meetings to approve vaccines even as thousands died daily, failed to approve the AstraZeneca vaccine, failed to quickly approve rapid antigen tests, and failed to perform inspections necessary to keep pharmaceutical supply lines open.
I am a long-time critic of the FDA and frankly I am stunned at the devastation.
Let the AZ Vaccine Go!
Finally the NYTimes has picked up on a story I have been shouting from the rooftops for months.
Tens of millions of doses of the coronavirus vaccine made by the British-Swedish company AstraZeneca are sitting idly in American manufacturing facilities, awaiting results from its U.S. clinical trial while countries that have authorized its use beg for access.
…About 30 million doses are currently bottled at AstraZeneca’s facility in West Chester, Ohio, which handles “fill-finish,” the final phase of the manufacturing process during which the vaccine is placed in vials, one official with knowledge of the stockpile said.
Emergent BioSolutions, a company in Maryland that AstraZeneca has contracted to manufacture its vaccine in the United States, has also produced enough vaccine in Baltimore for tens of millions more doses once it is filled into vials and packaged, the official said.
…But although AstraZeneca’s vaccine is already authorized in more than 70 countries, according to a company spokesman, its U.S. clinical trial has not yet reported results, and the company has not applied to the Food and Drug Administration for emergency use authorization. AstraZeneca has asked the Biden administration to let it loan American doses to the European Union, where it has fallen short of its original supply commitments and where the vaccination campaign has stumbled badly.
The administration, for now, has denied the request, one official said.
Some federal officials have pushed the White House to make a decision in the next few weeks. Officials have discussed sending doses to Brazil, which has been hard hit by a worsening coronavirus crisis, or the European Union or Britain.
The AZ vaccine could have saved thousands of lives in the US, if it had been approved earlier. But it’s not going to be approved in the US for months at best and with the ramp up in production of Pfizer, Moderna, J&J and now Novavax it’s no longer needed in the US. Let it go! Send it to Canada or Mexico or Brazil or COVAX.
In our Science Paper we estimate that another 1 billion courses of vaccine capacity are worth $1 trillion of additional global benefits. AZ has on the order of 50 million doses nearly ready to go and can produce in the US around 25 million doses a month so over a year that production is worth over $100 billion to the world economy, far higher than the modest cost of production! Instead of idling this capacity we should expand it even further as part of a plan to vaccinate the world.
It’s a Biden Plan to vaccinate the world or a Xi Jinping Plan and I’d rather it be a Biden Plan.
Why vaccination passports probably won’t work well
That is the topic of my latest Bloomberg column, here is one excerpt:
One issue is what exactly constitutes proof of vaccination. For my vaccinations, I have been issued a rather flimsy, easy-to-forge paper document from the Centers for Disease Control. Unlike a passport or a dollar bill, it has no embedded watermarks or other protections. Anyone with a moderately sophisticated copy machine could create many fake documents, or perhaps steal an existing stash of these documents and sell them on the black market. Once you have the documents, you can simply note that you have been vaccinated, and it is not easy for outside parties to dispute such claims.
Soon enough, of course, it may be easier for most adults to get a vaccine than to forge a vaccine passport. Still, U.S. laws and regulations work better when they can refer to clear, verifiable standards of evidence. It is hard to imagine a set of laws or procedures based on criteria so loose that they basically allow anyone to claim they are vaccinated. A more stringent standard, however, would be hard for most vaccinated Americans to meet.
Another knotty question is which vaccines will count for the passport. Pfizer’s, Moderna’s and Johnson & Johnson’s for sure, but what if you are a U.S. citizen living in Canada who received AstraZeneca’s vaccine, which has been approved by some 15 nations but not the U.S.? Is the federal government willing to tell a whole class of responsible individuals that they cannot fly on U.S. planes? Or will the vaccine-passport bureaucracy be willing to approve vaccines that the Food and Drug Administration will not?
These dilemmas can become stickier yet. What about Sputnik, the Russian vaccine, or the numerous Chinese vaccines, which are being administered around the world, including in Mexico?
Do Americans really wish to create a country to which most foreigners would not be very welcome? Furthermore, what counts as proof of foreign vaccination? Some Asian countries, including China, are creating elaborate and supposedly secure vaccine verification systems, using advanced information technology. Good for them — but how would that connect with U.S. regulations? How many different passport systems would a flight attendant or gate agent have to read, interpret and render judgment upon?
The likely result of all this: Many foreign visitors to the U.S. would never quite know in advance whether they could board an airplane or attend a public event.
And how would the passport reflect any new vaccines deemed necessary? What if new Covid-19 strains require booster shots? What if you’ve had Covid and thus get only one shot for now rather than two, as many experts are recommending? What will happen as the number of vaccines around the world proliferates? Given the slowness of the FDA and CDC, it is hard to imagine any new U.S. approvals coming quickly. A vaccine passport system could end up being fetters not only for foreigners and anti-vaxxers but also for vaccinated Americans.
Recommended, there are additional arguments at the link.
Detroit Fauci
The mayor of Detroit has turned down an allocation of the J&J vaccine.
Detroit Mayor Mike Duggan declined an initial allocation of the newly authorized Johnson & Johnson Covid-19 vaccine….”So, Johnson & Johnson is a very good vaccine. Moderna and Pfizer are the best. And I am going to do everything I can to make sure the residents of the city of Detroit get the best,” Duggan said during a news conference Thursday.
Sigh. What an error. Note, however, that the Detroit Mayor rejecting the J&J vaccine is exactly what the FDA has done with the AstraZeneca vaccine. Moreover none other than Anthony Fauci made exactly the same argument about AstraZeneca (an argument I criticized at the time):
But even if the vaccine ends up being approved, it will probably only have an efficacy of 60 to 70 percent. “What are you going to do with the 70 percent when you’ve got two (vaccines) that are 95 percent? Who are you going to give a vaccine like that to?” Anthony Fauci, the leading American expert on vaccines, recently wondered.
To be clear, I don’t blame Fauci for the actions of Detroit Mayor Mike Duggan. Duggan would probably have said the same had Fauci never made his error. Indeed, perhaps you might even read this as excusing Duggan (if even Fauci, “the leading American expert on vaccines”, could make this error then…).
Still, Fauci’s error has been much more costly for the United States.
Hat tip: JF.
Canada: An Official Strong Recommendation for First Doses First
Canada’s National Advisory Committee on Immunization (NACI), a scientific advisory group to the government, has made a forceful and dramatic statement strongly favoring First Doses First (delay the second dose.) This is a very big deal for the entire world. Basically NACI have endorsed everything that Tyler and I have said on First Doses First since my first post tentatively raised the issue on December 8. I am going to quote this statement extensively since it’s an excellent summary. No indentation.
—-NACI Statement—-
Based on emerging evidence of the protection provided by the first dose of a two dose series for COVID-19 vaccines currently authorized in Canada, NACI recommends that in the context of limited COVID-19 vaccine supply jurisdictions should maximize the number of individuals benefiting from the first dose of vaccine by extending the second dose of COVID-19 vaccine up to four months after the first. NACI will continue to monitor the evidence on effectiveness of an extended dose interval and will adjust recommendations as needed. (Strong NACI Recommendation)
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- In addition to emerging population-based data, this recommendation is based on expert opinion and the public health principles of equity, ethics, accessibility, feasibility, immunological vaccine principles, and the perspective that, within a global pandemic setting, reducing the risk of severe disease outcomes at the population-level will have the greatest impact. Current evidence suggests high vaccine effectiveness against symptomatic disease and hospitalization for several weeks after the first dose, including among older populations.
Protecting individuals
- By implementing an extended four month interval strategy, Canada will be able to provide access to first doses of highly efficacious vaccines to more individuals earlier which is expected to increase health equity faster. Canada has secured enough vaccines to ensure that a second dose will be available to every adult.
- As a general vaccination principle, interruption of a vaccine series resulting in an extended interval between doses does not require restarting the vaccine series. Principles of immunology, vaccine science, and historical examples demonstrate that delays between doses do not result in a reduction in final antibody concentrations nor a reduction in durability of memory response for most multi-dose products.
- Assessment of available data on efficacy and effectiveness of a single dose of mRNA vaccine was a critical factor in assessing the impact of a delayed second dose at this time. The two available clinical trials for mRNA vaccines (Pfizer-BioNTech and Moderna) provide evidence that indicates that efficacy against symptomatic disease begins as early as 12 to 14 days after the first dose of the mRNA vaccine. Excluding the first 14 days before vaccines are expected to offer protection, both vaccines showed an efficacy of 92% up until the second dose (most second doses were administered at 19-42 days in the trials). Recently, real world vaccine effectiveness data presented to or reviewed by NACI assessing PCR-positive COVID-19 disease and/or infection from Quebec, British Columbia, Israel, the United Kingdom and the United States support good effectiveness (generally 70-80%, depending on the methodology used and outcomes assessed) from a single dose of mRNA vaccines (for up to two months in some studies). While studies have not yet collected four months of data on effectiveness of the first dose, the first two months of population-based effectiveness data are showing sustained and high levels of protection. These data include studies in health care workers, long term care residents, elderly populations and the general public. While this is somewhat lower than the efficacy demonstrated after one dose in clinical trials, it is important to note that vaccine effectiveness in a general population setting is typically lower than efficacy from the controlled setting of a clinical trial, and this is expected to be the case after series completion as well.
- Published data from the AstraZeneca clinical trial indicated that delaying the second dose to ≥ 12 weeks resulted in a better efficacy against symptomatic disease compared to shorter intervals between doses.
- The duration of protection from one or two doses of COVID-19 vaccines is currently unknown. Experience with other multi-dose vaccines after a single dose suggests persistent protection could last for six months or longer in adolescents and adults. Longer-term follow-up of clinical trial participants and those receiving vaccination in public programs will assist in determining the duration of protection following both one and two doses of vaccination. NACI will continue to monitor the evidence on effectiveness of an extended interval, which is currently being collected weekly in some Canadian jurisdictions, and will adjust recommendations as needed if concerns emerge about waning protection.
Protecting populations
- Although effectiveness after two-doses will be somewhat higher than with one dose, many more people will benefit from immunization when extending the interval between doses in times of vaccine shortage; offering more individuals direct benefit and also the possibility of indirect benefit from increasing population immunity to COVID-19 disease. Everyone is expected to obtain the full benefit of two doses when the second dose is offered after 4 months.
- Internal PHAC modelling reviewed by NACI based on Canadian supply projections suggested that accelerating vaccine coverage by extending dose intervals of mRNA vaccines could have short-term public health benefits in preventing symptomatic disease, hospitalizations, and deaths while vaccine supply is constrained. Even a theoretical scenario analysis in which intervals were extended up to six months and protection was lost at a rate of 4% per week after the first dose also showed that extending the mRNA vaccine dose intervals would still have public health benefits. External modelling results have also suggested that extending dose intervals can avert infections, hospitalizations and deaths.
- The impact on variants of concern by extending the interval between doses is unknown, but there is currently no evidence that an extended interval between doses will either increase or decrease the emergence of variants of concern. COVID-19 mRNA vaccines and AstraZeneca vaccine have shown promising early results against variant B.1.1.7. As effectiveness of the first dose against other variants of concern is emerging, ongoing monitoring will be required.
- Vaccine distribution will be optimized through this strategy, and current vaccine supply projections will work well with an extended dose strategy that aims to immunize as many Canadians as efficiently as possible. Extending the dose intervals for mRNA vaccines up to four months has the potential to result in rapid immunization and protection of a large proportion of the Canadian population….
The English Data Support First Doses First
A new study from Public Health England shows that both the Pfizer and AstraZeneca vaccine work well from the first dose. If that sounds familiar it’s because the results are similar to those found in Scotland. The results cover all adults in England aged 70 years and older (over 7.5 million people).
Vaccination with either a single dose of BNT162b2 or ChAdOx1 COVID-19 vaccination was associated with a significant reduction in symptomatic SARS-CoV2 positive cases in older adults with even greater protection against severe disease [approximately 80% effective at preventing hospitalisation, AT] . Both vaccines show similar effects. Protection was maintained for the duration of follow-up (>6 weeks). A second dose of BNT162b2 provides further protection against symptomatic disease but second doses of ChAdOx1 have not yet been rolled out in England. There is a clear effect of the vaccines against the UK variant of concern.
Score three for the land of Reverend Bayes: first doses first, approve AstraZeneca, approve AstraZeneca for the elderly.
We now have significant real world data from millions of vaccine recipients in Israel, Scotland and England and it is very supportive of First Doses First and Approve AstraZeneca.
The US FDA is not following the science.
A Biden Plan for World Vaccination
Canada has approved the AstraZeneca vaccine. The US has not. The US has paid for an AstraZeneca factory in Baltimore and stockpiled millions of doses. The US should lease the factory to Canada or simply make the doses available for export. The same factory will also produce the J&J vaccine so it’s possible that there is some small opportunity cost. Exporting vaccine to our close ally, trading partner, and neighbor, however, would create significant political, economic, and health benefits for the United States.
More generally, the US is focused on vaccinating its residents first. That’s understandable. But step two is vaccinating the world. The Kremer team advocated going big on vaccine capacity for two reasons. First, we needed a lot of capacity to vaccinate the US fast and fast was valuable. Second, going big meant that the US could vaccinate its population quickly but then have that capacity available to vaccinate the rest of the world.
Contrary to what many people feared, Operation Warp Speed hasn’t taken doses from the rest of the world, Operation Warp Speed has built the infrastructure to deliver doses to the rest of the world. Our motto in advising governments and NGOs was ‘Capacity is the antidote to conflicts over distribution.‘
The United States will soon be the first big country with a fully vaccinated population. The US will then have a chance to lead the world into the post-pandemic era with a “Biden plan” for world vaccination akin to the Mashall Plan.
Invest more. Vaccinate the world. End the pandemic.
Start with Canada.
Seatbelt Now or Wait for Airbag?
Should you take a less efficacious vaccine or wait for a more efficacious vaccine? The individual and social incentives are in conflict. For society as a whole it’s typically much better if everyone takes the less efficacious vaccine sooner. We show one example of this in the supplementary material to the Science Paper with details under different scenarios in a forthcoming paper but the intuition is clear. Herd immunity is herd immunity. In the final analysis what you care about is not your chances of overcoming the disease if challenged (the vaccine efficacy) but your chances of overcoming the disease if challenged times the probability of being challenged. Herd immunity means pushing the latter number close to zero which is more important than modest differences in efficacy rates.
What about at the individual level? If you have a choice, it’s clearly better to get the more efficacious vaccine, especially since both vaccines are free (the price system has its advantages in clearing markets). But if you have to wait for the more efficacious vaccine, the choice isn’t obvious. Many people in Europe aren’t taking the AstraZeneca vaccine in the hopes of getting an mRNA vaccine later but I think that is a mistake. Don’t fail to wear your seatbelt today because your next car may have airbags. I’d be happy to take the AstraZeneca vaccine today, if only the government would let me.
Moreover, there is little reason to believe that you can’t follow-up the J&J or AstraZeneca vaccine with a mRNA vaccine at a later date.* If we will be taking multiple SARS-COV-2 vaccines over the next 10 years, as seems likely, it really doesn’t matter much which one we get first.
Do yourself and your society a favor by getting whatever vaccine is available.
Everything in this post applies even more strongly to a country making decisions. Buy the vaccine with the earliest delivery date! And don’t forget to consider the Gamaleya, Sinovac and Sinopharm vaccines.
* Multiple shots of adenoviral vector vaccines such as AZ may become less efficacious overtime as people’s bodies recognize the vector.
Following the science? — the show so far
As the pace of recovery quickens, and most balance sheets continue to look decent, it seems increasingly obvious that $1.9 trillion is too much to spend. We are spending at least $1 trillion too much, with very little investment to show for it, and $1 trillion is a lot of money. Heaven forbid they should make part of the stimulus dependent on future macroeconomic variables, which is what science would suggest.
New CDC school opening guidelines fail to “follow the science.” School reopening is a big, big issue. Overall the blue states are not doing well on it, and the Biden administration is hurting rather than helping.
Vaccine distribution is doing better, with 2.4 million doses distributed per day by the end of this last week. I am less sure how much that is above the previous trajectory. At least originally, Biden was boasting of aspiring to doing one million doses a day, so the presidential grasp of detail is not what pushed us over the edge here.
Those are arguably the three most important issues at the moment, and the overall performance level is not great.
The AstraZeneca vaccine still is not approved, with no sign of an FDA budge in sight. Canada approved it last week, so now there are more than fifteen nations on board. The new data on its performance are quite strong, even for a single dose.
Biden will be appointing an FDA head, but I haven’t heard talk of reform in spite of major and ongoing failures, and some in process reforms in the UK. Is it even permissible to raise the topic of “the deregulations we need”?
The $15 minimum wage idea seems doomed to fail, in any case it was obviously worse than an “indexed by state” approach, even if you hold the Dube-ous view of minimum wage economics.
The emergency facility — a vestige of the Trump administration that was open for only a month in summer 2019 — is being reactivated to hold up to 700 children ages 13 to 17.
By the way, arrests of unaccompanied children at the border are up 50% this month (WSJ). So this problem isn’t going away. Is science being used to structure the incentives properly for these migrants?
That issue aside, immigration is the one policy area where there has been major sustained improvement, and where those improvements are likely to continue.
As far as I know, there is no immediate plan to eliminate or lower the Trump tariffs on Chinese goods.
The (non-scientific) belief in a new era of cooperation with Europe, including in opposition to China, already lies in tatters.
I don’t know if the American military should have bombed Syria, but I do know that it did and I suspect our government also does not know if it should have, not really know in the scientific sense.
I do get that the Biden administration “feels more scientific” to you, and it has the demeanor of a proper establishment, and it offers experts much higher status, and it does not encourage yahoos to storm the Capitol, for which I am very grateful.
But the rather obvious evidence here is that the scientific record is already quite poor.
Cool, green Britannia
Over the summer of 2020, as coronavirus cases fell and life in Britain felt briefly normal, something very abnormal was happening to the country’s electricity supply. No coal was burned to generate any portion of it for a period of more than two months, something that had not happened since 1882. Britain’s four remaining coal-burning power plants are zombies, all but dead. Within a couple of years they will be closed and Britain will probably never burn coal for electricity again.
The elimination of power stations that burn coal has helped Britain cut its carbon emissions faster than any other rich country since 1990 (see charts). They are down by 44%, according to data collected by the Department for Business, Energy and Industrial Strategy (BEIS) during a period when the economy grew by two-thirds. Germany’s emissions, in contrast, are down by 29%; coal is still burned to generate some 24% of its electricity. Britain has made cuts to its emissions 1.8 times larger than the EU average since 1990. In America, emissions over the same period are up slightly.
Here is the full article from The Economist. I’ll say it again, whether it is AI, the Oxford/Astrazeneca vaccine, the speed of the current vaccination program, this switch to greener energy, the reemergence of Oxbridge, the new Dominic Cummings-inspired DARPA-like science funding plan, or London being the world’s best city — current Great Britain remains grossly underrated.
The First Dose is Good
WSJ: The Covid-19 vaccine developed by Pfizer Inc. and BioNTech SE generates robust immunity after one dose and can be stored in ordinary freezers instead of at ultracold temperatures, according to new research and data released by the companies.
The findings provide strong arguments in favor of delaying the second dose of the two-shot vaccine, as the U.K. has done . They could also have substantial implications on vaccine policy and distribution around the world, simplifying the logistics of distributing the vaccine.
A single shot of the vaccine is 85% effective in preventing symptomatic disease 15 to 28 days after being administered, according to a peer-reviewed study conducted by the Israeli government-owned Sheba Medical Center and published in the Lancet medical journal. Pfizer and BioNTech recommend that a second dose is administered 21 days after the first.
The finding is a vindication of the approach taken by the U.K. government to delay a second dose by up to 12 weeks so it could use limited supplies to deliver a single dose to more people, and could encourage others to follow suit. Almost one-third of the U.K.’s adult population has now received at least one vaccine shot. Other authorities in parts of Canada and Europe have prioritized an initial shot, hoping they will have enough doses for a booster when needed.
Preliminary data also suggest that the other widely used vaccine in the U.K. developed by AstraZeneca PLC and the University of Oxford could have a substantial effect after a first dose .
The Israeli findings came from the first real-world data about the effect of the vaccine gathered outside of clinical trials in one of the leading nations in immunization against the coronavirus. Israel has given the first shot to 4.2 million people—more than two-thirds of eligible citizens over 16 years old—and a second shot to 2.8 million, according to its health ministry. The country has around 9.3 million citizens.
…”This groundbreaking research supports the British government’s decision to begin inoculating its citizens with a single dose of the vaccine,” said Arnon Afek, Sheba’s deputy director general.
The Israeli study is here. Data from Quebec also show that a single dose is highly effective, 80% or higher (Figure 3) in real world settings.
It’s becoming clearer that delaying the second dose is the right strategy but it was the right strategy back in December when I first started advocating for First Doses First. Waiting for more data isn’t “science,” it’s sometimes an excuse for an unscientific status-quo bias.
Approximately 16 million second doses have been administered in the US. If those doses had been first doses an additional 16 million people would have been protected from dying. Corey White estimates that every 4000 flu vaccinations saves a life which implies 4000 lives would have been saved by going to FDF. COVID, of course, is much deadlier than the flu–ten times as deadly or more going by national death figures (so including transmission and case fatality rate)– so 40,000 deaths is back of the envelope. Let’s do some more back-of-the-envelope calculations. Since Dec. 14, there have been approximately 10 million confirmed cases in the United States and 200,000 deaths. There are 200 million adults in the US so 1/1000 adults has died from COVID, just since Dec. 14. If we use 1/1000 as the risks of a random adult dying from COVID, then an additional 16 million vaccinations would have saved 16,000 lives. But that too is likely to be an underestimate since the people being vaccinated are not a random sample of adults but rather adults with a much higher risk of dying from COVID. Two to four times that number would not be unreasonable so an additional 16 million vaccinations might have avoided 32,000-64,000 deaths. Moreover, an additional 16 million first doses would have reduced transmission. None of these calculations is very good but they give a ballpark.
It is excellent news that the vaccine is stable for some time using ordinary refrigeration. Scott Duke Kominers and I argue that there is lot of unused vaccination capacity at the pharmacies and reducing the cold storage requirement will help to bring that unused capacity online. The announcement is also important for a less well understood reason. If Pfizer is only now learning that ultra-cold storage isn’t necessary then we should be looking much more closely at fractional dosing.
When I said that we should delay the second dose, people would respond with “but the companies say 21 days and 28 days! Listen to the science!”. That’s not scientific thinking but magical thinking. Listening to the science was understanding that the clinical trial regimen was designed at speed with the sole purpose of getting the vaccines approved. The clinical trial was not designed to discover the optimal regimen for public health. Don’t get me wrong. Pfizer and Moderna did the right thing! But it was wrong to think that the public health authorities could simply rely on “the science” as if it were written on stone. Even cold-storage wasn’t written on stone! Now that the public health authorities know that the clinical trial regimen isn’t written in stone they should be more willing to consider policies such as delaying the second dose and fractional dosing.
We are nearing the end in the US but delaying the second dose and other dose-stretching policies are going to be important in other countries.
The Big Push: A Plan to Accelerate V-Day
In the Washington Post I have an extensive piece on accelerating progress to V-day, Vaccine or Victory day, the day everyone who wants a vaccine has gotten one. I cover themes that will be familiar to MR readers, including First Doses First, Fractional Dosing, Approving More Vaccines and DePrioritization to Expand Delivery. I won’t belabor these points here but the piece is useful at collecting all the arguments in one place and there are lots of authoritative links.
One point I do want to make is that all the pieces of the “Tabarrok plan,” if you will, fit together. Namely, use First Doses First to make a big push to get as many people vaccinated with first doses as possible in the next 90 days. Approve more vaccines including Johnson & Johnson, AstraZeneca and others and make them available to anyone, anywhere–that is possible because these vaccines don’t require significant cold storage, J&J is a single shot and AZ is better with a second shot at 12 weeks or later all of which eases distribution.
…some people argue that adding a third (or fourth) vaccine might not help because of persistent delivery logjams at the state and local levels. But we know there is unused distributional capacity, even for the supply we do have. The United States is currently administering about 1.5 million coronavirus vaccine shots per day. While that sounds like a lot, for comparison consider that in September — during the pandemic, when social distancing measures were in full effect — we vaccinated for the seasonal flu in some weeks at the rate of 3 million people a day.
There are two main reasons the rollout has been so slow. First, the Moderna and especially the Pfizer vaccines require ultracold storage. (The Johnson & Johnson and AstraZeneca doses can be stored at ordinary refrigerator temperatures.) Second, we have tried to prioritize vaccinations using a confusing mishmash of age, health conditions and essential-worker status that differs by state and sometimes even by county. “Confirming such criteria is complicated at best, and it’s probably not even feasible to try under conditions of duress,” as Baylor’s Hotez puts it.
Arguments continue about prioritization lists, and the idea of tossing them entirely would cause a political fight. But there is a compromise at hand: Quickly approve the Johnson & Johnson and AstraZeneca vaccines and make them — and only them — available to anyone, anywhere. Keeping things simple is a sure way to increase total vaccinations. With no cold-storage requirement, the new vaccines could be administered by any of the 300,000 pharmacists and more than 1 million physicians in the United States authorized to deliver vaccines, most of whom are not now giving Pfizer or Moderna shots.
Osterholm on First Doses First
Here from a podcast is Michael Osterholm, Regents Professor, McKnight Presidential Endowed Chair in Public Health, the director of the Center for Infectious Disease Research and Policy (CIDRAP) and state epidemiologist for the Minnesota Department of Health.
…Imagine you are setting across the table from two people both of whom are 65 or older, both with underlying health conditions. You have two doses of vaccine, one in each hand. And you say to them I can give two doses to you or to you but then the other person gets nothing. Or I can give one dose to both of you. And this is what I know. At the very least, one dose is likely to prevent serious illness, hospitalization and death. Two doses will probably even prevent clinical disease with B.1.1.7. But the other one of you; if you get infected with this virus, which I think substantial numbers of Americans will, things are not looking good for you. What do you want me to do?
If that is your Mom or Dad. Your Grandpa or Grandma. What would you do?
This is where the rubber meets the road. I think if the data bears it out we can save so many lives in the upcoming weeks and we are missing that opportunity.
I have already made my choice. I am postponing my second dose. I want my second dose. But I am confident that I can wait. And I can only hope that my second dose, which I have just deferred, will go to someone who it will save their life. It will make a totally different world for that family.
You know some could argue that this could be the end of my career. But I could not sleep with myself at night if I didn’t do this. I just know in my heart of hearts that this is something we must do if we are going to save lives.
The entire podcast is worthwhile, this is from around minute 44:30 (my imperfect transcription).
Hat tip: Anon.
Addendum: Many other countries should be looking very closely at dose-stretching policies.
In other news, South Korea approves the AstraZeneca vaccine. It’s not like we have anything to learn from South Korea about managing a pandemic, right? Right?