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Moderna’s Covid-19 vaccine is poised to roll out within days.

The Food and Drug Administration on Friday issued an emergency use authorization for Moderna’s Covid-19 vaccine, clearing the way for it to be the second vaccine distributed in the United States. The decision follows a vote on Thursday by an advisory committee to the FDA which found that the benefits of the vaccine outweigh its harms for people ages 18 years old and older.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn, in a statement.

Between the Pfizer/BioNTech vaccine that received a green light last week and the Moderna vaccine, US officials were expecting to have enough doses to vaccinate 20 million Americans by the end of the month. However, some states reported Thursday that they had received fewer doses than they were promised of the Pfizer/BioNTech vaccine.

Both of these vaccines use an mRNA platform to get human cells to make a component of SARS-CoV-2, the virus that causes Covid-19. That component, the spike protein of the virus, is then used by the immune system to build up protection against the pathogen. It’s an approach that is seeing widespread use in humans for the first time. Both vaccines are also administered as two doses; the doses of the Moderna vaccine are spaced 28 days apart, while the Pfizer/BioNTech vaccine doses are spread 21 days apart.

Moderna’s vaccine can be stored long-term at minus 20 degrees Celsius (minus 4 degrees Fahrenheit) and is stable for 30 days between 2° and 8°C (36° to 46°F). In contrast, the Pfizer/BioNTech vaccine needs temperatures of minus 70°C (minus 94°F). The less stringent storage requirements of Moderna’s product may ease some of the logistical challenges of distributing a vaccine.

The task of getting delicate vaccines from manufacturers to hospitals and into the hands of patients is complicated, something that will have to be scaled up to immunize millions of people across the United States.

Already, the distribution of the Pfizer/BioNTech vaccine has hit some bumps. State officials are reporting that their allocations of the vaccine have been suddenly downscaled, while Pfizer said that there are millions of doses of its vaccine that have gone unclaimed.

.@CDCgov has informed us that WA’s vaccine allocation will be cut by 40 percent next week — and that all states are seeing similar cuts.

This is disruptive and frustrating. We need accurate, predictable numbers to plan and ensure on-the-ground success.

No explanation was given.

— Governor Jay Inslee (@GovInslee) December 17, 2020

Though having a second vaccine on the market increases the number of people who can get immunized, it could also complicate the distribution process further, with more doses to track, transport, and administer.

Health officials are also warning recipients about potential side effects of these vaccines. At least four people who received the Pfizer/BioNTech vaccine under an EUA experienced severe allergic reactions. While effects this severe are very rare, some doctors are pointing out that reactions to these vaccines can be more intense than responses to other inoculations, as Vox’s Julia Belluz explained:

What’s now clear: An injection with either vaccine, both of which use mRNA technology, can feel more intense than other routine vaccinations (such as the flu shot) — with side effects for some recipients such as pain, headache, and fatigue. And this may be especially true for Moderna’s vaccine: About 16 percent of people who got the shot in clinical trials experienced a “severe” systemic adverse reaction, a classification the FDA uses to refer to side effects, like fever or fatigue, that require medical attention and prevent people from going about their daily activities.

Per guidelines set by an advisory group for the Centers for Disease Control and Prevention, the first people slated to receive the Moderna vaccine will be the same as those for the Pfizer/BioNTech vaccine — health workers and residents and staff at long-term care facilities. The US government has purchased 100 million doses of each of these vaccines to be delivered through the end of March.

An EUA, however, is still short of a full approval, and there are still some outstanding concerns that need to be addressed. Moderna noted in its briefing document that the company is still trying to find out how long the vaccine’s protection lasts, how well it prevents transmission, and its long-term impacts. The company says it will monitor its trial pool for two years and will conduct additional studies among the people who receive the vaccine under an EUA to get answers to these questions.

Lawmakers have delayed a vote on stimulus and government funding until Sunday.

Congress has delayed a vote on stimulus and government funding — again.

Although lawmakers were originally facing a self-imposed December 18 deadline to get both things done, they’ve postponed it once more by passing another short-term spending bill on Friday. Because Congressional leaders had extended a previous deadline on government funding, they just approved a two-day addition. Now, the House and the Senate have a bit more time to pass the spending legislation and the stimulus bill they intend to attach to it.

The latest continuing resolution is set to keep the government funded through the end of the day on Sunday, December 20. Lawmakers have said they hope to have ironed out their differences on a coronavirus relief agreement by then, with House leaders signaling that the earliest vote they plan to hold would take place Sunday afternoon.

“I think we’re very close to getting an agreement, I think two more days would allow us the time to get it done and allow time for people to be able to read,” House Minority Leader Kevin McCarthy said on Friday.

Top lawmakers from both parties hadn’t begun negotiations on this stimulus agreement in earnest until earlier this week, with the end of the term looming over them. (The $1.4 trillion government funding bill, meanwhile, has proven less contentious.)

The anticipated stimulus legislation, which is expected to net out at around $900 billion, won’t include the controversial corporate liability protections, nor will it include state and local aid provisions, though it is poised to contain more funding for unemployment insurance, small business support, and another round of stimulus checks.

Lawmakers now have two days to work through the remaining sticking points.

What’s still being worked on

Although the most contested provisions have been stripped from the bill, there are still some issues that lawmakers are debating.

As the Washington Post reports, some of the ongoing negotiations center on the number of weeks of expanded unemployment insurance (UI) the bill would cover: While a prior bipartisan draft had provided an additional $300 in UI for 16 weeks, the amount of coverage in a final compromise bill could be much shorter.

There’s also an ongoing disagreement over the amount that would be included in another round of stimulus checks, with Sens. Bernie Sanders (I-VT) and Josh Hawley (R-MO) pushing for $1,200 payments while the leadership plan initially offered $600 options. Sen. Ron Johnson (R-WI) on Friday opposed $1,200 payments twice and cited concerns about gains to the deficit, an issue on which most Americans disagree with him.

Despite these delays, lawmakers on both sides of the aisle have emphasized that they’re committed to getting more stimulus done, even if it means staying in session longer. There are, of course, no guarantees they will wrap up discussions by Sunday. At this point, it’s been nine months since lawmakers passed their last major relief package, nine months in which millions of people have been laid off and tens of thousands of businesses have grappled with closing.

With a record number of Americans dying of Covid-19 every day, immunizing the public against the virus is more urgent than ever. But hundreds of millions of people in the US are simply going to have to wait — probably several months — to get a vaccine.

Instead of the 300 million doses the Trump administration originally promised before the end of the year, the two vaccine developers first in line for Food and Drug Administration approval — Pfizer/BioNTech and Moderna — expected to ship 35 million to 40 million doses total before January. Since both vaccines are supposed to be dispensed at two shots per person, that’s enough supply for no more than 20 million people.

But even reaching that many people will take some time. The first batch of the Pfizer/BioNTech vaccine shipped from a Kalamazoo, Michigan, factory Sunday, following the FDA’s emergency use authorization Friday night, and will include only 2.9 million doses. (A scientific committee that advises the FDA will consider whether to recommend authorization of emergency use of Moderna’s vaccine on December 17.)

The vaccine developers say efforts to meet their initial year-end targets are being hampered by shortages of raw ingredients. And on December 18, state officials raised concerns about drastically reduced second-week shipments for the Pfizer/BioNTech vaccine. Delays from the federal government mean the US could miss its target of 20 million first-dose vaccinations by the end of the year.

Both Moderna and Pfizer/BioNTech have vowed to ramp up production next year, but the exact amount they’ll make still isn’t clear, and the estimates keep shifting. Moderna currently says it’ll have 85 million to 100 million doses for the US ready in the first quarter of 2021; Pfizer plans to provide 50 million doses at the end of the second quarter and another 50 million in Q3, according to the Washington Post. The US government declined to purchase additional doses of the Pfizer/BioNTech vaccine earlier in the year.

And Pfizer/BioNTech and Moderna aren’t the only vaccine providers falling short of their original targets: AstraZeneca and Oxford — another vaccine team that was supposed to deliver up to 300 million doses, or 60 percent of the US coronavirus vaccine supply — have been beset by safety and transparency problems that caused them to fall weeks behind on finishing their phase 3 US trial.

To be clear, the effort to identify, test, and manufacture a Covid-19 vaccine has unfolded at remarkable speed. By the middle of next year, we may have several effective vaccines to choose from. But while the vaccines offer hope for the end of the pandemic, they are far from a quick fix. For the foreseeable future, doses will be scarce — not even enough to cover the highest-risk groups, like health workers and long-term care residents. The federal government’s allocation strategy also means some states (such as Wyoming) will have more supplies for top-priority groups than others (like New York). This scarcity is forcing local health officials and administrators across the country to make ethically fraught decisions about which lives most urgently need protecting from Covid-19.

Who is likely to go first?

The effort to figure out who should get immunized first ultimately falls to the states, but they are getting advice from the federal government, which has better information on the safety and efficacy of the vaccines and decides how many doses states will get.

The Advisory Committee on Immunization Practices, an expert group that makes recommendations on vaccination policy to the US Centers for Disease Control and Prevention, put health personnel, along with staff and residents of long-term care facilities, at the front (phase 1a). In addition, two other influential health bodies have weighed in on the question of the highest-priority groups: The World Health Organization (WHO) and the National Academies of Sciences, Engineering, and Medicine (NASEM) also put health workers first, and, in the case of NASEM, first responders too. Again, though, local health authorities have the power to decide whom to prioritize (though ACIP is likely to have the most influence on US vaccine rationing decisions).

“Because all [ACIP] can do is make recommendations, those recommendations are going to be implemented in vastly different ways across the country,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. “And those [differences] have to do with whether you’re a red state or blue state, a mayor or governor.”

What’s already clear: Even the highest-priority groups won’t be fully vaccinated straightaway.

Operation Warp Speed, the task force in charge of national vaccine distribution, will distribute the initial batch of 2.9 million doses of Pfizer/BioNTech vaccines in proportion to states’ adult populations. (A second batch of 2.9 million doses is being reserved so the first group of people to be immunized have access to their second shot three weeks later.)

The initial shipment from Pfizer will cover only 12 percent of the people in ACIP’s phase 1a (again, health workers and staff and residents of long-term care homes), or 0.9 percent of the country’s adult population.

This means “states are going to need to make sub-prioritization decisions because the supply won’t cover the plan ACIP is proposing,” said Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics.

Most states have reported their estimates for expected doses in the first shipment, according to the state reports collected by Vox.

How many health workers and those in long-term care facilities will be covered by the first shipment of the vaccines?

The first batch of 2.9 million Pfizer/Biotech vaccines only cover a fraction of the 24 million health care workers and people in long-term care facilities across the country, the groups in phase 1a. The first order covers an average of 12 percent of this population across the nation. Some states would be able to immunize more, others fewer. 

    <img alt="This graphic shows the initial doses states receive cover a bigger share of the top priority groups in some states than others. " src="https://cdn.vox-cdn.com/thumbor/ZWjz5lfk186NljlX-52DOxiJWrY=/800x0/filters:no_upscale()/cdn.vox-cdn.com/uploads/chorus_asset/file/22172708/vaccine_state_chart1.png" />
  <cite>Youyou Zhou for Vox</cite>

So far, it looks like some states with a higher share of health workers and long-term care home residents are going to be especially short on vaccine supplies. For example, places like Washington, DC, New York, and Ohio — where the population of those in phase 1a is over 10 percent of the state’s adult population, compared to the national average of around 7.5 percent — will be at a disadvantage. DC will only receive vaccines to cover about one-tenth of the health workforce, which is why officials there are petitioning the federal government not to tie the share of vaccines to its population.

On the other end of the spectrum, Oregon’s governor told the public that the first doses are “enough to provide vaccines to health workers — nurses, doctors and other support staff” — before the end of December. Alaska’s 35,100 doses, meanwhile, will cover 81 percent of its health workers and care home residents, about 5 percent of the state’s population. This is because it’s getting its total order for the month in one shipment to minimize logistical challenges in the sprawling state. 

    <img alt="The graphic shows that distributing the vaccines by state’s adult population puts some states at a disadvantage." src="https://cdn.vox-cdn.com/thumbor/wChkocUXDkbnf3NXSRJYNhH9SBA=/800x0/filters:no_upscale()/cdn.vox-cdn.com/uploads/chorus_asset/file/22172098/Vaccine_state_graphic_2.2.jpg" />

So distributing the vaccines by the state’s adult population means a young, healthy adult might be able to get vaccinated in some parts of the country sooner than others if the state has a relatively small high-risk population, including lower numbers of health workers.

Who goes next?

States submitted their initial distribution plans to the CDC months ago under the assumption that 300 million vaccine doses would be available by the end of the year. Now, faced with a much more limited supply, those plans are evolving, and as of Friday, many states still didn’t know for sure how many doses they were going to get this year.

Still, there are a few things we can expect. Across the country, once phase 1a is complete, states will continue moving through their priority groups. And this is where things get murkier and local health authorities may diverge significantly in their distribution plans.

In phase 1b, the WHO prioritizes older adults, while NASEM puts people of all ages with comorbidities and older adults living in congregate or crowded settings, such as nursing homes, next. ACIP has finalized its advice only for phase 1a, but the committee has already signaled it will focus on essential workers for phase 1b, only reaching seniors and people with comorbidities in phase 1c.

These groups are expected to be prioritized for vaccination in Phase 1 

    <img alt=" " src="https://cdn.vox-cdn.com/thumbor/c5JXmMNrZksJDr_3QUb9iqTkWoM=/800x0/filters:no_upscale()/cdn.vox-cdn.com/uploads/chorus_asset/file/22172738/acip_pop_amp.jpg" />
  <cite>Youyou Zhou for Vox</cite>

In placing seniors and people with comorbidities ahead of essential workers, the WHO and NASEM are putting the greatest value on preventing deaths (since these groups are at the highest risk of Covid-19 death). If ACIP goes ahead with its draft plans, it would be “trading off infections averted with deaths averted,” said Saad Omer, director at the Yale Institute for Global Health. For states, these rationing decisions will be even trickier if supply shortages persist, especially in areas with large groups of front-line workers and long-term care populations that need to go first.

We’ll learn more about the reality of vaccine distribution at the state level this week. The vaccines will land in 145 distribution centers across the country on Monday, 425 centers on Tuesday, and the last 66 on Wednesday, according to the Associated Press. And with the historic inoculation effort now underway, local health authorities will also need to manage a host of logistical hurdles — making sure the vaccines are stored properly, that there’s enough dry ice to keep them cold, and that people come back for their second shot. Unlike the flu shot, which comes in pre-filled syringes, each Pfizer/BioNTech vaccine vial delivers five doses, meaning health care workers will have the added challenge of avoiding contamination.

So even with an effective vaccine already being rolled out, there’s still a long battle ahead. That’s why Operation Warp Speed’s chief operating officer, Gustave Perna, compared America’s mass inoculation effort to D-Day, the military operation that culminated in the end of the Second World War.

“D-Day was the beginning of the end,” Perna said in a press briefing. “And that’s where we are today.”

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