“Both the Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in distributing the vaccine after six reported cases of cerebral venous sinus thrombosis (CVST). These clots block blood flowing out of the brain and can quickly turn deadly.
The complications were found in women between the ages of 18 and 48, and they arose between six and 13 days after receiving the Johnson & Johnson vaccine. “Of the clots seen in the United States, one case was fatal, and one patient is in critical condition,” said Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, during a Tuesday press conference.”
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“For regulators, the episode highlights the tricky challenge of balancing caution against an urgent need for a vaccine in a still-raging pandemic. And as they investigate the problem, they also have to try to maintain public confidence in the vaccination program. The pause helps show that regulators are taking potential problems seriously, but if they botch the messaging, that could make people less likely to get vaccinated.”
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“there are several factors that made regulators pay close attention to the recent cases following vaccinations with the Johnson & Johnson shot. Marks explained that patients with these clots also had thrombocytopenia, a condition where platelets in the blood drop to very low levels, leading to bleeding and bruising. The combination of blood clots and low platelets means that patients cannot receive conventional blood clot therapies like heparin, a blood thinner. That’s why health officials want to wait to resume vaccinations with the Johnson & Johnson vaccine until they can investigate the concern and come up with new guidelines if necessary.
Another factor is that these cases occurred in younger women, who normally don’t face a high risk of these types of clots.”
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“when vaccines make the jump from thousands of carefully screened trial participants to millions of people in the general population, rare problems — the one-in-a-million complications — start to emerge.”
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“Regulators could, then, take a similar approach with the Johnson & Johnson shot to the one they used for allergies and the mRNA vaccines, adding a screening criterion for people at highest risk of these blood clots before they receive the Johnson & Johnson vaccine.”
“Cuomo presented area hospitals with a double bind: Fail to use all of your vaccines and be fined up to $100,000, or vaccinate people out of order and be fined $1,000,000. Inoculating health care workers first may sound sensible on the surface, but that evaporates when you consider that logistical externalities often prevent providers from corralling such employees in perfect time. (The Moderna and Pfizer vaccines can last for several months while frozen, but after thawing they have a very short shelf-life.) If those hospitals strayed and found an alternative candidate outside the mandated plan, they would have met financial ruin.
That threat is not an empty one: At least one hospital is under investigation for daring to vaccinate school officials before their time came.
Cuomo has claimed that such rules are necessary to prevent shady providers from constructing vaccine bribery schemes and pushing their friends to the front of the line. That concern may not be utterly groundless, but there is no evidence of widespread inoculation fraud. Compromising the health of New Yorkers seems an inept response to a negligible risk. The benefit of keeping the state’s senior citizens alive surely trumps such a worry.
New York’s graduation to tier 1b is a step in the right direction—now 3.2 million more people can receive the vaccine without health care providers worrying about their careers ending. But the state is still excluding large swaths of senior citizens in favor of “critical infrastructure workers,” such as grocery attendants. Those workers are providing a vital service, but many are also young and healthy, with much less risk of dying should they contract COVID-19.”
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“people have been known to ghost their vaccine appointments even as doses are nearing expiration, something that no health practitioner can foresee. As I wrote last week, the D.C. Department of Health permits providers to pull aside any willing recipient if they have surplus vaccines that would otherwise go to waste. New York’s regulations on who may benefit from those extra doses will likely still cause some to end up in the trash.”
“What the 95 percent figure really means here is that vaccinated people in the clinical trials had a 95 percent lower risk of getting COVID-19 compared with the unvaccinated control group participants. That means that vaccinated people were 20 times less likely than the control group to get COVID-19.”
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” There is even more good news about COVID-19 vaccine efficacy. As LiveScience reports, the Pfizer/BioNTech, Moderna, and Johnson & Johnson clinical trials all found that their vaccines were essentially 100 percent effective in preventing severe disease six to seven weeks after trial participants had received a first/single dose. As biotech journalist Anna Nowogrodzki notes, “Zero vaccinated people in any of the trials were hospitalized or died of COVID-19 after the vaccines had fully taken effect.” Now that’s the kind of vaccine efficacy that we can all cheer.”
“Vaccine supply chains are extremely specialized and sensitive, relying on expensive machinery, highly trained staff and finicky ingredients. Manufacturers have run into intermittent shortages of key materials, according to the U.S. Government Accountability Office; the combination of surging demand and workforce disruptions from the pandemic has caused delays of four to 12 weeks for items that used to ship within a week, much like what happened when consumers were sent scrambling for household staples like flour, chicken wings and toilet paper.
People often question why the administration can’t use the mighty Defense Production Act — which empowers the government to demand critical supplies before anyone else — to turbocharge production. But that law has its limits. Each time a manufacturer adds new equipment or a new raw materials supplier, they are required to run extensive tests to ensure the hardware or ingredients consistently work as intended, then submit data to the Food and Drug Administration. Adding capacity “doesn’t happen in a blink of an eye,” said Jennifer Pancorbo, director of industry programs and research at North Carolina State University’s Biomanufacturing Training and Education Center. “It takes a good chunk of weeks.”
And adding supplies at any one point only helps if production can be expanded up and down the entire chain. “Thousands of components may be needed,” said Gerald W. Parker, director of the Pandemic and Biosecurity Policy Program at Texas A&M University’s Scowcroft Institute for International Affairs and a former senior official in the Department of Health and Human Services office for preparedness and response. “You can’t just turn on the Defense Production Act and make it happen.”
The U.S. doesn’t have spare facilities waiting around to manufacture vaccines, or other kinds of factories that could be converted the way General Motors began producing ventilators last year. The GAO said the Army Corps of Engineers is helping to expand existing vaccine facilities, but it can’t be done overnight.
Building new capacity would take two to three months, at which point the new production lines would still face weeks of testing to ensure they were able to make the vaccine doses correctly before the companies could start delivering more shots.”
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“The Trump administration deployed the Defense Production Act last year to give vaccine manufacturers priority in accessing crucial production supplies before anyone else could buy them. And the Biden administration used it to help Pfizer obtain specialized needles that can squeeze a sixth dose from the company’s vials, as well as for two critical manufacturing components: filling pumps and tangential flow filtration units.”
“Netanyahu declared that Israel will be a “global model state for the rapid vaccination of an entire country.” But how much Israel’s success can be replicated abroad is hard to say. Israel’s small and densely packed population has eased some of the logistical and operational challenges of delivering the vaccine. And Israel’s universal health care system, which has easily accessible records for all citizens, has massively facilitated the program.”
“States scrambling to deploy millions of coronavirus vaccines are resorting to drastic measures as they wait for federal aid to help speed mass inoculations.
With about 4.8 million of the approximately 17 million doses shipped out by the federal government administered, state leaders like New York Gov. Andrew Cuomo are threatening steep fines for health providers that don’t use up all their shots this week; others are calling on retired health care workers, dentists and even veterinarians to staff vaccination sites. And many are reworking their carefully crafted distribution plans on the fly to get older Americans the shots sooner amid spiking infection rates and news that a more transmissible strain of the virus has reached the U.S.
The patchwork of responses comes as desperate governors are facing a vacuum of federal support, along with dire funding and workforce shortages that are hampering the pace of the rollout. Though Trump administration officials predict vaccination rates will pick up this week, the White House’s coronavirus task force has not convened a call with governors since Dec. 21. States have not yet seen the nearly $9 billion Congress approved to help vaccine distribution in a late December relief package.
“What we need from the federal government is for them to have started vaccine distribution planning much earlier in the year last year,” said Casey Katims, a federal liaison for Washington state.
Trump administration officials have repeatedly said that getting shots into arms is states’ responsibility. But it’s not clear whether states’ emergency measures will be enough to get the most ambitious inoculation campaign in U.S. history back on track. And the mishmash of state approaches is creating growing disparities around the country in who can get the vaccine. Some pharmacists have started offering leftover doses of the coveted vaccine to the general public before they spoil. In other parts of the country, people at high risk — including frontline workers — are still waiting for their shots.
“The distribution is moving slower than people had hoped,” said Clay Marsh, West Virginia’s Covid-19 czar. “We are not satisfied because we want to get vaccines in every West Virginian’s arm, but this is a massively complicated process.”
Officials with Operation Warp Speed, the Trump administration’s vaccine accelerator, have said that holidays, snowstorms and a significant reporting lag contributed to the smaller-than-expected vaccination numbers in December. More than 2.6 million people were inoculated out of the 20 million the federal government had repeatedly promised.
Administration officials rejected the notion that they have not given states adequate support. Federal officials talk to states multiple times a week and monitor statewide data to “learn how we can better assist future efforts,” a Department of Health and Human Services spokesperson said. And Vice President Mike Pence’s office said that the White House coronavirus task force is planning a call with governors for later this week or early next after not convening over the holidays.”
“If people can get a vaccine that is quite effective in preventing Covid-19 symptoms but still carry the virus, they could still potentially spread SARS-CoV-2. This is an important issue because there will only be very limited doses of the vaccine available once it’s cleared for emergency use — and it will likely be many months after that before a sizable amount of the US population will be able to be vaccinated. That means people who have received the injections might need to maintain precautions like wearing masks and social distancing to prevent further spread of the virus before the vast majority of people have been vaccinated.”
“Companies and industry groups from across the economy are undertaking efforts at the federal and state level to make the case that when it comes to the limited-supply Covid-19 vaccine, their employees should get priority. The meat industry, airlines, banks, retail, exterminators, restaurants, and zoos are among the myriad groups lobbying decision-makers. So are specific companies such as Amazon, Lyft, DoorDash, and Perdue. Unions are trying to get their members vaccines. Even professional sports leagues, like the NHL, are making a play.”
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“Ultimately, it is up to states to decide what to do with federal recommendations and decipher which people, including workers, go where. States could deviate from those guidelines — theoretically, a place like California could say entertainers should be higher up on the list, or in New York, bankers. Companies may have an easier time influencing decisions at the state and local level. But in general, states take the guidelines seriously and could face enormous backlash if they ignore them.”