New York: Why the Second COVID Shot Makes You Miserable

When the actress Sarah Wynter got her first dose of the Pfizer COVID-19 vaccine, she didn’t experience any side effects apart from a little soreness in her arm. Dose two was a different story. About 12 hours after she received it, as she was about to go to bed, “it hit me like a freight train,” she says. “I just started feeling very achy, very tired and heavy.”

She woke up the next morning experiencing what felt like the worst hangover of her life. After some Tylenol and coffee, she felt almost better by late morning and was well enough to host a small birthday party for her 10-year-old twins. Then, at bedtime, it was round two, this time including violent chills. A night’s rest helped, but the following day she still felt under the weather.

Wynter’s experiences may not have been exactly typical, but they weren’t unusual, either: The second dose of Moderna and Pfizer vaccines really do pack a wallop. A study by the Centers for Disease Control and Prevention found that while 30 percent of recipients experienced fatigue and a quarter suffered headaches after the first dose, those figures climbed to 54 percent and 46 percent, respectively, after the second dose. The number experiencing chills or fever climbed from 9 percent to 30 percent.

These unpleasant effects are a result of the way the immune system works. Continue reading New York: Why the Second COVID Shot Makes You Miserable

New York: So You’ve Been Vaccinated. When Are You Safe?

If you’ve recently received a COVID-19 vaccination, congratulations — but you’re not out of the woods. Right after your first dose, you’re as vulnerable to infection as you were before, since it takes time for your immune system to learn how to find and kill the coronavirus. When that happens, recipients of the Pfizer, Moderna, and Johnson & Johnson vaccines will all enjoy nearly 100 percent protection against hospitalization and death. So when can you start to feel safe? Sooner than you might think.

Pfizer and Moderna, the only vaccines to have published their Phase 3 trial results in a peer-reviewed journal, are both based on mRNA technology, and as might be expected showed similar trajectories. During the first two weeks after the first dose, recipients were almost as likely as control subjects given a placebo to develop COVID-19. But after that, the vaccinated infection rate dropped quickly. Pfizer’s data is more detailed, and it’s striking. Before day 11, vaccination offers very little protection. After day 11, the protection is substantial. Given the overall similarity in efficacy, presumably Moderna is the same way. (Johnson & Johnson’s vaccine uses a different technology, and detailed results of their Phase 3 study haven’t been published yet, so it’s harder to say what’s going on there.)

Rachel Roper, a professor of microbiology at East Carolina University, says this timing isn’t surprising. The body makes millions of white blood cells that are randomly shaped to match all possible unknown things. “Most just lie dormant and die, but if one binds a virus or other pathogen, it will become activated, and then proliferate, and then differentiate to be an effector cell, making antibodies or becoming a killer cell.  This is why it takes a week or two to get over an illness.  It takes time for these very few specific cells to activate and proliferate to large enough numbers to control infection.”

Looking at the Pfizer graph, the protection level is nearly binary: none, and then all. Day 11 after the first shot seems to be the magic point beyond which you can consider yourself vaccinated. Continue reading New York: So You’ve Been Vaccinated. When Are You Safe?

New York: The Story of One Dose

UPDATE: On April 13, the FDA and CDC recommended that use of Johnson & Johnson’s COVID-19 vaccine be suspended after six women developed serious blood clots after receiving a dose, one of whom died. The CDC will “review these cases and assess their potential significance,” the agencies said in a joint statement. While the cases amounted to less than one per million vaccinations, they resembled similar blood-clot events suffered by recipients of the vaccine made by AstraZeneca, which uses a similar adenovirus vector.

As an object, it’s not much: an inch and a half of glass with a stopper and some liquid inside. But a thimbleful of the stuff has amazing power — the ability to liberate us from our yearlong collective trauma. The fact that it’s available, scarcely a year after the start of a pandemic, is both an industrial miracle and a freakish stroke of luck; a decade ago, technology did not exist that could bring vaccines so quickly to the public’s arms.

Pfizer and Moderna crossed the finish line first, neck and neck, in December. The third and most recently approved vaccine was from Johnson & Johnson. The J&J vaccine holds some crucial advantages: Only one dose is required rather than two, and while the other approved vaccines expire 30 days after thawing, Johnson & Johnson’s lasts three months, making it easier to distribute in countries that lack an advanced cold chain. The story of the vaccine’s path from development to mass distribution is a lesson in the power of the global capitalist system — the network of corporations and supply chains that, though it can suffocate and disempower us as individuals, can also summon forth immense material and intellectual resources and deploy them for the greater good.

From the start, J&J struggled to catch a break. The pharmaceutical giant played it safe during development and lost crucial time, failed to get FDA approval for parts of its U.S. production chain, missed several delivery targets, and wound up with a vaccine that underperformed its rivals in clinical trials. Then, another obstacle: Last week, the New York Timesrevealed that the new batch J&J had pledged would be delayed even further, after a mix-up at a subcontractor’s production facility ruined 15 million doses. The Biden administration has since directed J&J to take over every aspect of vaccine production at the plant.

The setback was significant, but not fatal. The facility where the mix-up occurred was part of a production process that relies on a precise orchestration of timing, engineering, and logistical expertise across multiple continents, which makes it vulnerable to bad luck and human error. But the system is also resilient: When the batch of J&J doses was compromised, alternative supply lines were available to compensate for the failure. Here is how that entire tempestuous journey unfolded — the breakthroughs, the setbacks, and the way the pieces came together to bring vaccines to millions of arms. Continue reading New York: The Story of One Dose

New York: Why Has America’s Vaccination Drive Suddenly Stalled?

Operation Warp Speed stood as the Trump administration’s one gold-plated achievement, but now it’s looking more like a chintzy bronze façade. Having been denied access to federal vaccine-distribution plans during the transition, President Joe Biden’s incoming staffers said they were chagrined to find upon taking office that there were none. “We are going to have to build everything from scratch,” one source told CNN. Simultaneously, vaccine supplies unexpectedly dried up across the country, forcing New York City and other localities to suspend inoculations. “We’ve had to tell 23,000 New Yorkers who had an appointment this week that they will not be able to get that appointment for lack of supply,” said Mayor Bill de Blasio at a press conference Wednesday.

The first intimations of trouble came last week. “We usually hear what we’re going to get for the following week no later than Wednesday night,” says Andrew Rubin, vice-president for clinical affairs and ambulatory care at NYU Langone Health. “This particular Wednesday, we didn’t hear anything. That, of course, made us anxious. So we started talking to the state more emotionally aggressively on Thursday: Where’s the vaccine? Where’s the vaccine? And, quite frankly, nobody really knew where it was.”

By last Friday, NYU Langone Health had decided not to schedule any appointments for the week ahead. The Mount Sinai Health System began canceling appointments that had already been made. Only on Sunday did it receive confirmation that its allotment would fall short. “They didn’t have the supply to give us,” says Sue Mashni, Mount Sinai’s chief pharmacy officer. Continue reading New York: Why Has America’s Vaccination Drive Suddenly Stalled?

New York: The Vaccine Arsenal That Will Win the War on COVID

COVID’s endgame has begun. Vaccinations for the coronavirus got underway in the U.S. on Monday, using a vaccine produced by Pfizer, and approval is expected soon for another shot by Moderna. Both vaccines appear to be about 95 percent effective at preventing illness from COVID-19. The federal government expects to have enough of both vaccines to protect 150 million Americans by the end of June.

We’ve been remarkably lucky with vaccine development. Back in the spring, experts were cautioning that vaccines typically take decades to gain approval and that the mRNA technology used by Pfizer and Moderna had never before been approved for human use. These vaccines deliver packages of genetic material inside tiny capsules that infiltrate a patient’s cells and cause them to churn out one of the proteins that make up SARS-Cov-2 (the virus that causes COVID-19). The immune system learns to recognize this protein and thereby the entire living virus. Virologists expected that the technique would likely only be marginally effective, but the reality has turned out to be dramatically better than that. “Ninety-five percent effective — you couldn’t ask for higher efficacy,” says Rachel Roper, an immunologist at East Carolina University.

But there’s the problem of quantity. Vaccines for 150 million Americans leaves 100 million adults unprotected. For the rest, hope for a jab by the start of summer depends on the next round of vaccines to come through. Here, the road ahead is murkier, as there’s a lot of uncertainty about how effective the candidates will prove to be. Of the four currently undergoing testing as part of Operation Warp Speed, the federal government’s effort to fast-track production of vaccines, two have recently suffered stumbles. Continue reading New York: The Vaccine Arsenal That Will Win the War on COVID

New York: For Trump, the Most Dangerous Covid Phase Lies Ahead

Having first exhibited COVID-19 symptoms last Wednesday or Thursday, President Trump left Walter Reed medical center just as he was entering the disease’s danger zone. While he may seem outwardly fine, the complex interaction between the virus and his immune system taking place inside his body could quickly spiral out of control, according to experts.

The timing of the coronavirus’s peak danger is a function of how the virus attacks the body. During the early phase, the coronavirus multiplies inside the host’s cells and triggers the immune system response. It’s during this period that the first symptoms can manifest. The critical phase doesn’t come until seven to 10 days after the onset of symptoms, when the immune system can lurch dangerously into overdrive as it tries to beat back the infection.

It’s during this time that patients risk undergoing what’s called “decompensation” — a process in which the disease abruptly becomes life threatening, which can unfold over the course of hours. “People can be percolating along and doing fairly well, and then all of a sudden without warning, inexplicably just crash,” says Daniel Sterman, the director of pulmonary medicine, critical care, and sleep medicine at NYU Langone Health.

Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, calls it “falling off a cliff.” Continue reading New York: For Trump, the Most Dangerous Covid Phase Lies Ahead

New York: Trump’s COVID Case Could Be Mild or Fatal. Here Are Signs to Watch For.

Dr. Scott Atlas, a special adviser on coronavirus to President Trump, told Fox News that he expected the president and First Lady to make a “complete, full, and rapid recovery” following their coronavirus diagnosis. “I anticipate that he will be back on the road in full swing.”

That’s entirely possible. “Patients might have symptoms for only one or two days,” says Adolfo Garcia-Sastre, director of the Global Health and Emerging Pathogens Institute in the Icahn School of Medicine. But he cautions that the disease strikes with a wide range of severity, and even mild cases can last a week or more. And if Trump’s condition worsens, he could easily be out of commission until after the election.

The progression of the disease is usually charted from when a patient starts to manifest symptoms. At first — no matter what the eventual course the infection migt follow — it starts out gently, with symptoms that often include a low fever, cough, fatigue, muscle ache, and nausea. The White House reported today that Trump has “mild symptoms,” and Melania tweeted that she had “mild symptoms but feeling good.” Questions about the severity of the president’s condition were triggered, however, when Trump failed to take part in a call with state governors scheduled for 12:15 p.m. and was replaced without notice by Vice-President Pence.

The White House has announced that President Trump will be hospitalized at Walter Reed Medical Center, suggesting that his condition is on the moderate to severe end of things. It also said that he was given a dose of experimental Regeneron monoclonal antibody therapy, a treatment that has not been approved for use by the FDA. “He may be sicker that they let on,” says John Emy, a physician at New York University Langone Medical Center, while conceding that “he isn’t an average citizen, so they may be acting extremely conservatively.”

What to expect if Trump’s case is mild or moderate

According to CDC guidance, if the disease remains mild or moderate, patients will start to feel better after ten to 14 days, with a cough lasting an average of 19 days. But that does not mean that they will necessarily feel totally back to normal. A New York-area physician who came down with what she considers a moderate case had a fever for 14 straight days. “But it was a full month until I really felt back to normal,” said Peggy E. (who asked that her last name not be used). “A colleague who got sick at the same time still has periodic shortness of breath,” she said.

After patients recover, the CDC recommends that they remain isolated for at least ten days after the appearance of symptoms or three days after recovery — whichever comes later. In the scenario, the odds are small that Trump will be able to meet Joe Biden for their second debate on October 15.

What to expect if Trump’s case is severe

If Trump’s condition instead worsens and the infection rages, the critical turn for the worse would typically come around the end of the first week. The CDC reports that the time from onset of symptoms to acute-respiratory-distress syndrome — the buildup of fluid in the lungs that puts people in the ICU — is usually around eight to 15 days.

Atlas told Fox that Trump “is a very, very healthy guy and the overwhelming majority of people even at his age do fine with this. He is very healthy and so I anticipate the same for him.”

In reality, Trump suffers from three risk factors: In addition to being elderly, he is male and he is obese. While overall only 12.2 percent of people between 65 and 74 who come down with COVID-19 will wind up being hospitalized, men have twice the risk of women. Beyond that, obese people are 113 percent more likely to be hospitalized than those of normal weight.

There is little hospitals can do to cure the disease; drugs like remdesivir only offer a moderate reduction in recovery time. What medicine can do is mitigate the effects of complications like pneumonia, septic shock, heart arrhythmia, and secondary infections as the immune system fights the virus.

Take, for example, British prime minister Boris Johnson, who came down with COVID-19 on March 27. Like Trump, it started with a persistent cough and a fever. Ten days later, Johnson was hospitalized, and two days after that, moved to intensive care. In all, he spent seven nights in the hospital, followed by two weeks recovering at home, not working. If Trump follows a similar trajectory, he will be back on his feet around November 2.

But if his symptoms are severe, he could be in recovery for months. And for every thousand people in their mid-70s or older who get COVID-19, 116 will die.

GQ: What It Will Take to Get to a Vaccine

The first volunteers are already waiting when Rosa G. gets to the lab. She’s worked as a technician on human trials before but never seen people so eager to be injected with an experimental vaccine. She meets the first subject, a young woman in a mauve tank top, in an examination room. She has her sit, then draws a few milliliters of clear fluid from a clear vial.

“Ready?” Rosa asks.

“Yup,” the woman answers.

Rosa jabs the sharp end of the needle into the soft flesh of her tricep and presses the plunger. The woman looks exactly as she did a moment before, but in an instant her body has become something profoundly different: a new front line in the battle between mankind and the novel coronavirus. Hundreds of thousands have died of COVID-19, and more than seven billion immunologically defenseless bodies await like dry chaparral at the height of fire season.

Rosa has dosed the volunteer with an experimental vaccine made up of a mishmash of microscopic particles of the SARS-CoV-2 virus that have been chemically chopped up and rendered harmless, like a pistol run over by a steamroller. Though incapable of causing infection, to the immune system they are antigens: foreign particles that are unfamiliar and presumed dangerous. In response to their presence, the body learns to create antibodies that will circulate and latch onto any identical antigens they may encounter in the future. In swarming an antigen, antibodies prevent it from carrying out infection, and they also mark it for destruction by hunter-killer cells.

The idea behind this kind of vaccine, called “whole killed” or “inactivated,” has been successfully used many times in the past, from the Salk polio vaccine to annual flu shots. But will this formulation stimulate the body’s immune defenses enough? Or, conversely, will it trigger dangerous adverse reactions, like the 1976 swine flu vaccine that left 450 with a crippling neurological disease? Continue reading GQ: What It Will Take to Get to a Vaccine

Vanity Fair: The Dangers of Trump’s ‘Warp Speed’ Vaccine Race

The end of the COVID-19 pandemic will come with the development of a safe and effective vaccine, a process experts say will take at least 12 to 18 months. Last week, however, the U.S. Department of Health and Human Services (HHS) blew that timeline out of the water, announcing that it would pay British drugmaker AstraZeneca upwards of $1 billion for 300 million doses of an experimental vaccine, which will start to become available as early as this October. AstraZeneca CEO Pascal Soriot was even more bullish, telling CNN, “We will start getting substantial doses by September, October,” and that “lots and lots of people will be able to be vaccinated before the end of the year.” At that pace, Soriot confirmed, the entire U.S. and U.K. populations could be vaccinated by early 2021.

Soriot cautioned that the vaccine’s delivery depends on its successful completion of human trials—“It has to work,” he told CNN. But he said AstraZeneca was on target to prove that it will through an accelerated testing schedule. To date, the vaccine has been tested on monkeys and a small group of human volunteers, with recruitment for a 10,260-subject study currently underway.

To begin mass inoculations against COVID in the month before the election would be a massive achievement for the Trump administration, which has seen its prospects for a second term dwindle with the lockdown caused by the coronavirus and its resultant economic carnage. According to reporting by Vanity Fair’s Gabriel Sherman, Donald Trump has privately expressed the belief that a COVID-19 vaccine would be ready within months.

Many experts, however, say that it is impossible to reliably demonstrate the safety and efficacy of a drug in such a time frame. Moreover, absent those assurances, it would be unethical to give what is essentially an experimental vaccine to hundreds of millions of people. “You cannot do that,” says Maria Bottazzi, a microbiologist at the Baylor College of Medicine in Houston. Continue reading Vanity Fair: The Dangers of Trump’s ‘Warp Speed’ Vaccine Race

New York: Safe Exit: The Risk-Mitigation Guide to Life After Quarantine

You know how to stay 100 percent safe from the coronavirus: total isolation. Stay in lockdown, work from home, physically interact with no one. But there’s only so long you can live like that. Eventually, you have to start coming out into the world. And while doing so is certain to increase your chance of getting sick, an informed risk-mitigation strategy can help you keep the danger to yourself and others quite low.

A relatively safe strategy for exiting lockdown can be boiled down to a few basic principles: stay outdoors; wear a mask; stick to small groups; try to avoid passing around objects; wash your hands. 

Here are some activities at the safer end of the spectrum as you exit lockdown, along with some data-based guidance on how best to minimize the risks of transmission:

Go to the Beach

There’s been a lot of outrage expressed over photos of people jammed into parks and beaches, but meeting outdoors seems to be one of the safest ways to interact with real people. One recent study of 318 outbreaks in China found that only one occurred in an outdoor environment.

The environmental conditions found on a beach in summertime serve as a natural line of defense against COVID-19. A fresh ocean breeze can disperse the droplets of moisture that are expelled when an infected person coughs, sneezes, talks, or even just breathes. High humidity and temperature have been shown to slow transmission of the virus. And the UV radiation in sunlight kills a wide variety of pathogens on surfaces. (It’s absolutely false, however, to think that beaming UV light into the body would be effective, as President Trump has speculated.) Continue reading New York: Safe Exit: The Risk-Mitigation Guide to Life After Quarantine