As US regulators meet to possibly grant emergency approval to a Covid vaccine already being distributed in the UK, many Americans are asking when they too will be able to get their shots.
Amid warnings of a looming spike in cases attributed to the Thanksgiving holiday in November, states are now more desperate than ever to hear what the Food and Drug Administration (FDA) vaccine approval board decides after they meet on Thursday to discuss the Pfizer-BioNTech vaccine.
There are two vaccines, made by Moderna and Pfizer, that are both seeking emergency approval in the US. The FDA panel will meet again on 17 December to discuss Moderna’s request.
It comes as coronavirus cases explode across the country, with over 200,000 new cases reported per day throughout most of December. On Tuesday, the US topped 215,000 new cases in one day, again breaking its record.
The US has now recorded over 15 million cases since the pandemic began, and more than 286,000 deaths, according to Johns Hopkins University.
Here’s what you need to know about when the US will have a vaccine.
When will the vaccine be ready?
Both Pfizer and Moderna are seeking Emergency Use Authorization (EUA) for their vaccines from the FDA’s expert panel.
The EUA allows a drug to be used as a treatment while studies are still being carried out to determine safety and effectiveness. Critics say the process is less rigorous and more likely to lead to health complications.
The panel often votes at the end of the meeting, but sometimes it can take days or weeks before approval or rejection is decided.
The experts’ recommendations still have to be approved by the FDA’s vaccine chief, Dr Peter Marks, before rollout can begin.
Operation Warp Speed, the federal government’s vaccine distribution programme, says deliveries will begin within 24 hours of the FDA’s approval.
On Tuesday, President Trump signed an executive order aimed at prioritising jabs for US citizens, as other countries buy up supplies of vaccine.
Canada, which approved the Pfizer vaccine on Wednesday, said that even if the US attempts to hoard vaccine, Canada will still be able to continue Pfizer exports since the drug is produced in several factories outside of the US.
Moderna’s executives say most of the US company’s vaccine would be manufactured in Massachusetts.
Who will get the US vaccine first?
Federal officials at the Centers for Disease Control and Prevention (CDC) agree that the nation’s 21 million healthcare workers should be prioritised first, as well the three million elderly Americans living in long-term care homes.
But there is less consensus on how states should distribute it to other groups.
The nation’s approximately 87 million essential workers are expected to be next in line for the jab, but it will be up to states to decide which industries to prioritise. Will postal workers and meat-processing factory workers be included, for example?
Moncef Slaoui, Operation Warp Speed’s chief scientist, said he does not “expect the states to make uniform decisions”.
“Some may prefer long-term care facilities or the elderly, while others may prioritise their health care workers. It would be wrong to immunise 18-year-olds first. I hope no one does that. But otherwise it’s shades of grey.”
Officials say vaccinations for groups that are not at a high risk are expected to take place in the spring of 2021.
When will states get their vaccines?
Last week, states submitted their plans for the distribution of their first shipments of the Pfizer vaccine once they are available.
Most states have said they will stick with the CDC’s guidelines and begin by inoculating healthcare workers, followed by the elderly and those with health risks.
Pfizer says that they expect to produce enough doses for about 25 million people by the end of 2020. They had earlier pledged to have enough for 50 million Americans by the end of the year, but later said the “scale-up of the raw material supply chain took longer than expected”.
New York’s governor has said the state expects to receive doses for 170,000 people in the first rollout. Maine, which has been much less hard hit than New York and has a much smaller population, expects to receive about 12,000 Pfizer vaccines if the drug is approved by the FDA.
Both vaccines require a second round of injections. Some pharmacies have been tapped to use their electronic communications infrastructure to alert patients when it is time to receive their second shot.
For Pfizer, the second jab comes three weeks after the first. For Moderna it is four weeks after the first shot.
What happens next?
There are a few key dates coming up.
- 10 Dec – FDA could approve Pfizer
- 14 Dec – rollout of Pfizer vaccine could begin this week
- 17 Dec – FDA could approve Moderna
Pfizer plans to have 6.4 million doses ready for the US in its first rollout round in late December. Because two shots are required per person, that is enough for three million people, out of a total US population of 330 million.
By the following week, both Pfizer and Moderna are expected to have produced enough vaccines for another 10 million people. By the end of the month, both companies are anticipated to have produced enough vaccine for 30 million people.
Will the vaccine be mandatory?
According to a 1905 landmark Supreme Court case, states do have it in their power to require the vaccination of their residents.
The case, Jacobson v Massachusetts, arose during a smallpox epidemic in Cambridge, Massachusetts, in 1902 when one resident refused the vaccine.
At the time, Cambridge said all residents must get vaccinated or re-vaccinated, otherwise pay a $5 fine (which would be about $150 in 2020).
In its ruling, the Supreme Court said that the rights of the individual do not trump the need to ensure public safety.
“There is, of course, a sphere within which the individual may assert the supremacy of his own will and rightfully dispute the authority of any human government, especially of any free government existing under a written constitution,” wrote Supreme Court Justice John Marshall Harlan.
“But it is equally true that in every well-ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.”
However, the high court of Massachusetts later ruled that states lacked the authority to administer the injection, and could only issue fines for failing to do so.
Pennsylvania’s health secretary has said they will not issue any mandate, but Virginia’s top health official has said that they will consider issuing one once the vaccines are ready.
Will enough Americans trust it?
There are also ongoing concerns regarding how many Americans are willing to get vaccinated. A recent Gallup poll found that 58% of Americans say they would be willing to get the jab, up from a low of 50% in September.
It also remains to be seen how racial minorities – who are at a higher risk of catching the virus and dying from it – will be prioritised and what level of trust they will have in the government-issued vaccine.
Last month, New York’s governor decried the federal government’s immunisation plan as “discriminatory,” saying that distribution infrastructure such as pharmacies and hospitals are less prevalent in black and Latino communities.
In Alabama, distrust of government medical programmes is high among the state’s black population. This is due to the notorious mid-20th Century Tuskegee experiments, in which black syphilis patients were lied to and denied treatment so that researchers could study the deadly disease.
Public health experts have said mass inoculation against the virus could result in herd immunity, an essential step in curbing the spread of the disease.
None of the vaccines currently under review have been tested on pregnant or nursing women, meaning they will be unlikely to be advised by the government to get vaccinated.
Can companies require the vaccine?
Private companies in the US have the right to force their employees to get certain vaccines, experts say, but are unlikely to immediately do so once the vaccine is approved.
This is because the vaccines are both seeking approval under an emergency process that critics say could lead to health complications.
“Companies could theoretically issue a mandate, but in the current political climate it is very unlikely they will do so,” George Washington University Law professor Peter Meyers told Reuters. “Americans tend to shy away from mandates.”
Ford Motor Co and Kellogg Co have both said they will make the vaccine available to their employees on a voluntary basis.
Many hospitals and health clinics require annual flu shots, and all 50 states have vaccination requirements in place for school children.
Workers can be excused from a vaccine if they have health issues that forbid receiving a vaccine, or – in some states – if they have religious objections.
What will the vaccines cost?
In July, the US Department of Health and Human Services announced a $1.95bn (£1.45bn) deal to secure 100 million vaccine doses from Pfizer. The agreement also allows the US government to purchase an additional 500 million doses.
According to the New York Times, Pfizer offered the US the opportunity to purchase more vaccine at the time, but the Trump administration refused, possibly leading to delays in US shipments later on. Mr Trump has denied the report.
Moderna received nearly $1bn from the US government for coronavirus research. They are set to receive an additional $1.5bn for 100 million doses, according to a deal signed in August.
Billions of dollars have also been promised to other drug companies in the event that they are able to bring additional vaccines to market.
The CDC says that vaccines purchased with taxpayer money will free, but providers may still charge for administering the jab. That fee may be reimbursed by health insurance companies or the Medicaid and Medicare programmes – social safety nets for low income and elderly Americans.
States are also racing to acquire ultra-cold refrigerators that are capable of storing the Pfizer vaccine, which must be kept at temperatures of -70C (-94 F) and, in the UK, will be transported in special boxes of up to 5,000 doses, packed in dry ice.
Once delivered, it can be kept for up to five days in a fridge. And once out of the fridge it needs to be used within six hours.
Each refrigerator costs tens of thousands of dollars, and have been harder to find in recent days as hospitals race to purchase them.