So Where’s the Vaccine?

Perhaps you’ve been wondering where the vaccine is and how much is on the way. We’d know more if the previous administration hadn’t displayed an extraordinary combination of malevolence and incompetence. The good news is that we’ll know more soon. From The Guardian

The Biden administration has spent its first week in office attempting to manually track down 20m vaccine doses in the pipeline between federal distribution and administration at clinic sites, when a dose finally reaches a patient’s arm.

The Trump administration’s strategy pushed the response to the coronavirus pandemic to individual states and omitted pipeline tracking information between distribution and when the shot is actually administered, Biden administration officials told Politico.

The lack of data has now forced federal health department officials to spend hours on the phone tracking down vaccine shipments, the news website reported.

Nobody had a complete picture,” Dr Julie Morita, a member of the Biden transition team and executive vice-president of the Robert Wood Johnson Foundation, told Politico. “The plans that were being made were being made with the assumption that more information would be available and be revealed once they got into the White House.”

As of Saturday, 49 million doses of vaccine have been distributed by the federal government, but only 27 million administered by states, according to the US Centers for Disease Control and Prevention (CDC).

About two million of those doses are believed to be accounted for by a 72-hour lag in reported administration, Politico reported. That still leaves millions in the pipeline between delivery and patient. At least 16 states have used less than half the vaccine doses distributed to them, USA Today reported this week.

Much of our work over the next week is going to make sure that we can tighten up the timelines to understand where in the pipeline the vaccine actually is and when exactly it is administered,” Dr Rochelle Walensky, [the new] director of the CDC, told USA Today.

. . . The CDC’s first report on early vaccine rollout is expected in February.

Where We Stand with the Vaccinations

The vaccine is out there. It’s not being administered fast enough. But now there’s a plan. From The New York Times [with commentary included]:

President Biden’s promise to administer 100 million vaccines by his 100th day in office is no longer a lofty goal; it is attainable at the current pace at which shots are going into arms. In fact, some experts have suggested that the president’s ambition is far too modest. [His ambition is to get the whole country vaccinated; his promise was to do 100 million by late April.]

Federal data shows that the United States is already administering about one million doses a day, and even doubling that rate would not cause the country to fall short of distribution capacity or supply. . . . 

Mr. Biden made the 100-day pledge in early December, before any vaccine had been authorized for use in the United States. At the time, experts called the goal “optimistic” given their concerns about manufacturing and distribution capacity.

Since then, two vaccines have been approved and the United States has secured contracts for deliveries of doses through July. And while some jurisdictions have said that they are running out of doses, states and U.S. territories are using only about half of the shots that the federal government has shipped to them, on average. . . .

Pfizer and Moderna have pledged to deliver a combined 200 million doses by the end of March, with an additional 200 million doses to be delivered by the end of July.

Under those circumstances, it is feasible that up to two million doses could be given per day, and Mr. Biden’s goal of 100 million shots could be reached by early March.

But ramping up vaccinations will not be easy. And national supply and distribution figures do not reflect the often complicated local realities.

“The complexity of administering vaccines may grow over the coming weeks as we open up a lot of new provider sites,” said Dr. Julie Swann, an industrial and systems engineering professor at North Carolina State University who was an adviser to the C.D.C. during the 2009 H1N1 pandemic.

Getting shots in arms has already been hard, Dr. Swann noted. Providers get little notice of how much vaccine they will receive, making it difficult to plan and set up appointments. Estimating demand can be tricky too, which means that vaccines may be used more quickly in some locations than others, leading to wasted doses.

“The administration needs to be both fighting immediate fires and putting in the infrastructure to make this work better, too,” Dr. Swann said [which is what the president and his staff are doing, three days after the inauguration].

Unquote.

The new administration has issued a “National Strategy for the COVID-19 Response and Pandemic Preparedness”. This is the summary of the plan to “mount a safe, effective, comprehensive vaccination campaign”:

The United States will spare no effort to ensure Americans can get vaccinated quickly, effectively, and equitably. The federal government will execute an aggressive vaccination strategy, focusing on the immediate actions necessary to convert vaccines into vaccinations, including improving allocation, distribution, administration, and tracking. Central to this effort will be additional support and funding for state, local, Tribal, and territorial governments — and improved line of sight into supply — to ensure that they are best prepared to mount local vaccination programs. At the same time, the federal government will mount an unprecedented public campaign that builds trust around vaccination and communicates the importance of maintaining public health measures such as masking, physical distancing, testing, and contact tracing even as people receive safe and effective vaccinations. To mount a safe, effective, comprehensive vaccination campaign, the United States will:

  1. Ensure the availability of safe, effective vaccines for the American public.
  2. Accelerate getting shots into arms and get vaccines to the communities that need them most.
  3. Create as many venues as needed for people to be vaccinated.
  4. Focus on hard-to-reach and high-risk populations.
  5. Fairly compensate providers, and states and local governments for the cost of administering vaccinations.
  6. Drive equity throughout the vaccination campaign and broader pandemic response. Launch a national vaccinations public education campaign.
  7. Bolster data systems and transparency for vaccinations.
  8. Monitor vaccine safety and efficacy. Surge the health care workforce to support the vaccination effort.

The plan is only 200 pages long.

Yeah, we’re finally getting an administration that’s competent and wants the government to work. Patience is a virtue.

This Is Almost Unbelievable

From The Washington Post (MY EMPHASIS ADDED):

When Health and Human Services Secretary Alex Azar announced this week that the federal government would begin releasing coronavirus vaccine doses held in reserve for second shots, NO SUCH RESERVE EXISTED, according to state and federal officials briefed on distribution plans. The Txxxx administration had already begun shipping out what was available beginning at the end of December, taking second doses directly off the manufacturing line.

Now, health officials across the country who had anticipated their extremely limited vaccine supply as much as doubling beginning next week are confronting the reality that their allocations will not immediately increase, dashing hopes of dramatically expanding eligibility for millions of elderly people and those with high-risk medical conditions. Health officials in some cities and states were informed in recent days about the reality of the situation, while others are still in the dark.

Unquote.

A message from our local doctors:

Untitled

Dear SMG Patient,

Recent eligibility changes for the COVID-19 vaccine have created a massive spike in demand for the vaccine. AT THIS TIME WE ARE NOT ABLE TO ACCOMMODATE ADDITIONAL VACCINE APPOINTMENT REQUESTS.

The volume of appointment requests via phone and through our patient portal is limiting our ability to care for patients who need both sick and well visits. 

We will contact eligible patients as soon as we are able to vaccinate you.

Unquote.

One reasonable theory: These bastards want millions of people to be disappointed that they can’t get a vaccination and blame the president — who will be Joe Biden five days from now.

I hope Biden puts a paragraph in his inaugural address (a “by the way, folks”) explaining that the outgoing administration claimed they’d have many millions of us already vaccinated, but they totally screwed up and then lied about it on their way out the door.

Hope vs. Reality, or the Vaccination Blues

From The New York Times:

In April, with hospitals overwhelmed and much of the United States in lockdown, the Department of Health and Human Services produced a presentation for the White House arguing that rapid development of a coronavirus vaccine was the best hope to control the pandemic.

“DEADLINE: Enable broad access to the public by October 2020,” the first slide read, with the date in bold.

Given that it typically takes years to develop a vaccine, the timetable for the initiative, called Operation Warp Speed, was incredibly ambitious. With tens of thousands dying and tens of millions out of work, the crisis demanded an all-out public-private response, with the government supplying billions of dollars to pharmaceutical and biotechnology companies, providing logistical support and cutting through red tape.

It escaped no one that the proposed deadline also intersected nicely with President Txxxx’s need to curb the virus before the election in November.

“Hey, if Operation Warp Speed ‘curbs the virus’ by October, the 200,000 dead will be forgotten and I’ll win a beautiful victory, the biggest win ever!”

Thus our president is hoping. 

I hope his staff doesn’t disappoint him by sharing this from The Washington Post.

In the public imagination [and between the president’s ears], the arrival of a coronavirus vaccine looms large: It’s the neat Hollywood ending to the grim and agonizing uncertainty of everyday life in a pandemic.

But public health experts are discussing among themselves a new worry: that hopes for a vaccine may be soaring too high. The confident depiction by politicians and companies that a vaccine is imminent and inevitable may give people unrealistic beliefs about how soon the world can return to normal — and even spark resistance to simple strategies that can tamp down transmission and save lives in the short term.

Two coronavirus vaccines entered the final stages of human testing last week, a scientific speed record that prompted top government health officials to utter words such as “historic” and “astounding” . . .

As the plotline advances, so do expectations: If people can just muddle through a few more months, the vaccine will land, the pandemic will end and everyone can throw their masks away. But best-case scenarios have failed to materialize throughout the pandemic, and experts — who believe wholeheartedly in the power of vaccines — foresee a long path ahead.

“It seems, to me, unlikely that a vaccine is an off-switch or a reset button where we will go back to pre-pandemic times,” said Yonatan Grad, an assistant professor of infectious diseases and immunology [at Harvard].

Or, as Columbia University virologist Angela Rasmussen puts it, “It’s not like we’re going to land in Oz.”

The declaration that a vaccine has been shown safe and effective will be a beginning, not the end. Deploying the vaccine to people in the United States and around the world will test and strain distribution networks, the supply chain, public trust and global cooperation. It will take months or, more likely, years to reach enough people to make the world safe.

For those who do get a vaccine as soon as shots become available, protection won’t be immediate — it takes weeks for the immune system to call up full platoons of disease-fighting antibodies. And many vaccine technologies will require a second shot weeks after the first to raise immune defenses.

Immunity could be short-lived or partial, requiring repeated boosters that strain the vaccine supply or require people to keep social distancing and wearing masks even after they’ve received their shots. And if a vaccine works less well for some groups of people, if swaths of the population are reluctant to get a vaccine or if there isn’t enough to go around, some people will still get sick even after scientists declare victory on a vaccine — which could help foster a false impression it doesn’t work.

A proven vaccine will profoundly change the relationship the world has with the novel coronavirus and is how many experts believe the pandemic will end. In popular conception, a vaccine is regarded as a silver bullet. But the truth — especially with the earliest vaccines — is likely to be far more nuanced. Public health experts fear that could lead to disappointment and erode the already delicate trust essential to making the effort to vanquish the virus succeed.

The drive to develop vaccines is frequently characterized as a race, with one country or company in the lead. The race metaphor suggests that what matters is who reaches the finish line first. But first across the line isn’t necessarily the best — and it almost certainly isn’t the end of the race, which could go on for years.

“The realistic scenario is probably going to be more like what we saw with HIV/AIDS,” said Michael S. Kinch, an expert in drug development and research at Washington University . . . “With HIV, we had a first generation of, looking back now, fairly mediocre drugs. I am afraid — and people don’t like to hear this, but I’m kind of constantly preaching it — we have to prepare ourselves for the idea we do not have a very good vaccine. My guess is the first generation of vaccines may be mediocre.”

Unquote.

In other words, reality isn’t reality TV.

People Have Said This Is the Best Article About the Virus

A science and health reporter, Donald McNeill, who specializes in “plagues and pestilences”, consulted “more than 20 experts in public health, medicine, epidemiology and history” and then wrote a long article for The New York Times. It’s called “ The Coronavirus in America: The Year Ahead”. It’s received a lot of praise. These are the parts (2,200 words or so) I found most interesting. The article has many links that aren’t included below.

What follows is divided into sections:

How Many Will Die
The Lockdowns Will End, But Haltingly
Immunity Will Become an Advantage in Society
A Vaccine Is Not Coming Soon
Treatments Are Likely To Arrive First
We Will Need International Cooperation

[ How Many Will Die ]

In fast-moving epidemics, far more victims pour into hospitals or die at home than doctors can test; at the same time, the mildly ill or asymptomatic never get tested. Those two factors distort the true fatality rate in opposite ways. If you don’t know how many people are infected, you don’t know how deadly a virus is.

Only when tens of thousands of antibody tests are done will we know how many silent carriers there may be in the United States. The C.D.C.  has suggested it might be 25 percent  of those who test positive. Researchers in Iceland  said it might be double that.

China is also revising its own estimates. In February, a  major study  concluded that only 1 percent of cases in Wuhan were asymptomatic.  New research  says  perhaps 60 percent  were. Our knowledge gaps are still wide enough to make epidemiologists weep.

“All models are just models,” Dr. Anthony S. Fauci, science adviser to the White House coronavirus task force, has said. “When you get new data, you change them.”

There may be good news buried in this inconsistency: The virus may also be mutating to cause fewer symptoms. In the movies, viruses become more deadly. In reality, they usually become less so, because asymptomatic strains reach more hosts. Even the 1918 Spanish flu virus eventually  faded into the seasonal H1N1 flu.

At the moment, however, we do not know  exactly how transmissible  or lethal the virus is. But refrigerated trucks parked outside hospitals tell us all we need to know: It is far worse than a bad flu season.

[ The Lockdowns Will End, But Haltingly ]

The next two years will proceed in fits and starts, experts said. As more immune people get back to work, more of the economy will recover.

But if too many people get infected at once, new lockdowns will become inevitable. To avoid that, widespread testing will be imperative.

Dr. Fauci has said “the virus will tell us” when it’s safe. He means that once a national baseline of hundreds of thousands of daily tests is established across the nation, any viral spread can be spotted when the percentage of positive results rises.

Detecting rising fevers as they are mapped by … smart thermometers may give an earlier signal…

But diagnostic testing has been troubled from the beginning. Despite assurances from the White House, doctors and patients continue to complain of delays and shortages.

To keep the virus in check, several experts insisted, the country also must start isolating all the ill — including mild cases.

In this country, patients who test positive are asked to stay in their homes, but keep away from their families.

Television news has been filled with recuperating personalities like CNN’s Chris Cuomo, sweating alone in his basement while his wife left food atop the stairs…

But even Mr. Cuomo ended up illustrating why the W.H.O. strongly opposes home isolation. On Wednesday, he revealed that his wife had the virus.

“If I was forced to select only one intervention, it would be the rapid isolation of all cases,” said Dr. Bruce Aylward, who led the W.H.O. observer team to China.

In China, anyone testing positive, no matter how mild their symptoms, was required to immediately enter an infirmary-style hospital — often set up in a gymnasium or community center outfitted with oxygen tanks and CT scanners.

There, they recuperated under the eyes of nurses. That reduced the risk to families, and being with other victims relieved some patients’ fears…

Still, experts were divided on the idea of such wards. [One called for] mandatory but “humane quarantine processes.”

By contrast, [a Harvard epidemiologist] opposed the idea, saying: “I don’t trust our government to remove people from their families by force.”

Ultimately, suppressing a virus requires testing all the contacts of every known case. But the United States is far short of that goal.

Someone working in a restaurant or factory may have dozens or even hundreds of contacts. In China’s Sichuan Province, for example, each known case had an average of 45 contacts.

The C.D.C. has about 600 contact tracers and, until recently, state and local health departments employed about 1,600, mostly for tracing syphilis and tuberculosis cases.

China hired and trained 9,000 in Wuhan alone. [It’s been] estimated that the United States will need at least 300,000.

[ Immunity Will Become an Advantage in Society ]

Imagine an America divided into two classes: those who have recovered from infection with the coronavirus and presumably have some immunity to it; and those who are still vulnerable.

“It will be a frightening schism,” … a World Health Organization special envoy on Covid-19, predicted. “Those with antibodies will be able to travel and work, and the rest will be discriminated against.”

Already, people with presumed immunity are very much in demand, asked to donate their blood for antibodies and doing risky medical jobs fearlessly.

Soon the government will have to invent a way to certify who is truly immune. A test for IgG antibodies, which are produced once immunity is established, would make sense… Many companies are working on them.

Dr. Fauci has said the White House was discussing certificates like those proposed in Germany. China uses cellphone QR codes linked to the owner’s personal details so others cannot borrow them….

As Americans stuck in lockdown see their immune neighbors resuming their lives and perhaps even taking the jobs they lost, it is not hard to imagine the enormous temptation to join them through self-infection, experts predicted. Younger citizens in particular will calculate that risking a serious illness may still be better than impoverishment and isolation.

“My daughter, who is a Harvard economist, keeps telling me her age group needs to have Covid-19 parties to develop immunity and keep the economy going,” said Dr. Michele Barry…

It would be a gamble [since] even slim, healthy young Americans have died of Covid-19.

[ A Vaccine Is Not Coming Soon ]

Even though limited human trials of three candidates — two here and one in China — have already begun, [Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases] has repeatedly said that any effort to make a vaccine will take at least a year to 18 months.

All the experts familiar with vaccine production agreed that … that timeline was optimistic… The record is four years, for the mumps vaccine.

Researchers differed sharply over what should be done to speed the process. Modern biotechnology techniques using RNA or DNA platforms make it possible to develop candidate vaccines faster than ever before.

But clinical trials take time, in part because there is no way to rush the production of antibodies in the human body.

Also, for unclear reasons, some previous vaccine candidates against coronaviruses like SARS have triggered “antibody-dependent enhancement,” which makes recipients more susceptible to infection, rather than less….

A new vaccine is usually first tested in fewer than 100 young, healthy volunteers. If it appears safe and produces antibodies, thousands more volunteers — in this case, probably front-line workers at the highest risk — will get either it or a placebo in what is called a Phase 3 trial.

It is possible to speed up that process with “challenge trials.” Scientists vaccinate small numbers of volunteers, wait until they develop antibodies, and then “challenge” them with a deliberate infection to see if the vaccine protects them.

Challenge trials are used only when a disease is completely curable, such as malaria or typhoid fever. Normally, it is ethically unthinkable to challenge subjects with a disease with no cure, such as Covid-19.

But in these abnormal times, several experts argued that putting a few Americans at high risk for fast results could be more ethical than leaving millions at risk for years….

As arduous as testing a vaccine is, producing hundreds of millions of doses is even tougher, experts said.

Most American vaccine plants produce only about 5 million to 10 million doses a year, needed largely by the 4 million babies born and 4 million people who reach age 65 annually…

But if a vaccine is invented, the United States could need 300 million doses [assuming 30 million of us are immune] — or 600 million if two shots are required. And just as many syringes.

“People have to start thinking big,” [one doctor] said. “With that volume, you’ve got to start cranking it out pretty soon.”

Flu vaccine plants are large, but those that grow the vaccines in chicken eggs are not suitable for modern vaccines…

European countries have plants but will need them for their own citizens. China has a large vaccine industry, and may be able to expand it over the coming months. It might be able to make vaccines for the United States…

India and Brazil also have large vaccine industries. If the virus moves rapidly through their crowded populations, they may lose millions of citizens but achieve widespread herd immunity well before the United States does. In that case, they might have spare vaccine plant capacity.

Alternatively, [another doctor said] the government might take over and sterilize existing liquor or beer plants, which have large fermentation vats: “ any distillery could be converted”.

[ Treatment Is Likely To Arrive First ]

In the short term, experts were more optimistic about treatments than vaccines. Several felt that so-called convalescent serum could work.

The basic technique has been used for over a century: Blood is drawn from people who have recovered from a disease, then filtered to remove everything but the antibodies. The antibody-rich immunoglobulin is injected into patients.

The obstacle is that there are now relatively few survivors to harvest blood from [note: in New Jersey at least, you have to be under 60, among other requirements]….

[A treatment involving] monoclonal antibodies … recently came very close to conquering the Ebola epidemic in eastern Congo, [and] are the most likely short-term game changer…

The most effective antibodies are chosen, and the genes that produce them are spliced into a benign virus that will grow in a cellular broth.

But, as with vaccines, growing and purifying monoclonal antibodies takes time. In theory, with enough production, they could be used not just to save lives but to protect front-line workers….

Having a daily preventive pill would be an even better solution, because pills can be synthesized in factories far faster than vaccines or antibodies can be grown and purified.

But even if one were invented, production would have to ramp up until it was as ubiquitous as aspirin, so 300 million Americans could take it daily.

[Some keep suggesting] hydroxychloroquine and azithromycin… All the experts agreed … that no decision should be made until clinical trials are completed.

Some recalled that in the 1950s inadequate testing of thalidomide caused thousands of children to be born with malformed limbs. More than one hydroxychloroquine study has been halted after patients who got high doses developed abnormal heart rhythms.

“I doubt anyone will tolerate high doses, and there are vision issues if it accumulates,” [one doctor] said. “But it would be interesting to see if it could work [like pills used to prevent H.I.V.].

Others were harsher… “It’s total nonsense,” said … a former director of medical and biodefense preparedness at the National Security Council. “I told my family, if I get Covid, do not give me this combo.”

Chloroquine might protect patients hospitalized with pneumonia against lethal cytokine storms because it damps down immune reactions, several doctors said.

That does not, however, make it useful for preventing infections, as [some have] implied it would be, because it has no known antiviral properties.

Several antivirals, including remdesivir, favipiravir and baloxavir, are being tested against the coronavirus; the latter two are flu drugs.

Trials of various combinations in China are set to issue results by next month, but they will be small and possibly inconclusive…

[ We Will Need International Cooperation ]

A public health crisis of this magnitude requires international cooperation on a scale not seen in decades. Yet [the president] is moving to defund the W.H.O., the only organization capable of coordinating such a response.

And he spent most of this year antagonizing China, which now has the world’s most powerful functioning economy and may become the dominant supplier of drugs and vaccines. China has used the pandemic to extend its global influence, and says it has sent medical gear and equipment to nearly 120 countries [including the United States]….

“If [the president] cares about stepping up the public health efforts here, he should look for avenues to collaborate with China and stop the insults,” said … an economic historian… [A doctor added:] “What if they come up with the first vaccine? They have a choice about who they sell it to. Are we top of the list? Why would we be?”

Once the pandemic has passed, the national recovery may be swift…

The psychological fallout will be harder to gauge. The isolation and poverty caused by a long shutdown may drive up rates of domestic abuse, depression and suicide.

Even political perspectives may shift…. In the periods after both wars, society and incomes became more equal. Funds created for veterans’ and widows’ pensions led to social safety nets, measures like the G.I. Bill and V.A. home loans were adopted, unions grew stronger, and tax benefits for the wealthy withered.

If a vaccine saves lives, many Americans may become less suspicious of conventional medicine and more accepting of science in general…