As the United States nears another grim milestone of 300,000 deaths from the coronavirus, a leading vaccine company has received approval from the U.S. Food and Drug Administration.
Anticipation for the vaccine has been growing after nine months of devastation. Last week, the U.K. became the first country to deliver a COVID-19 shot developed by U.S. drugmaker Pfizer and German company BioNTech. Pfizer applied for emergency use authorization (EUA) last month and on Friday, the authorization was granted, making their COVID-19 vaccine the first to be approved in the U.S.
With access to a vaccine so close, ABC News spoke to several experts about some of the most common questions people have about the COVID-19 vaccine.
When can I get the vaccine and how?
The goal of Operation Warp Speed is to produce and deliver 300 million doses of safe and effective COVID-19 vaccines, with initial doses available by January 2021.
But there is still a way to go. If both the Pfizer and Moderna vaccines are authorized by the FDA, there will likely be enough for only 20 million people by the end of the year. Both vaccines require two doses.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted on Dec. 1 to recommend that health care personnel and long-term care facility residents be the first to access a COVID-19 vaccine.
The panel of nongovernmental experts that comprise the ACIP will meet again to discuss prioritizations for the next phase of vaccine distribution, which could include police, firefighters and those in other essential fields like education and food production. Those who are 65 and older are expected to follow after essential workers.
The CDC is working with state, tribal, territorial and local jurisdictions on vaccination plans for their areas. They are also working with national chain pharmacies like CVS Health and Walgreens.
People will be able to use the plan as a guide to find where the COVID-19 vaccine is being administered, said John Brownstein, chief innovation officer at Boston Children’s Hospital and Harvard University professor.
Brownstein, an ABC News contributor, runs Vaccine Finder, a system developed by Google that’s meant to help people find health care providers that administer vaccines close to where they live. He says users will be able to find locations that administer the COVID-19 vaccine by early next year.
“Vaccine Finder is the main tool being deployed by the U.S. government to essentially allow every American to know where they can get the vaccine, where it's available and when to get it,” Brownstein told ABC News. “And it will be the resource that everyone can count on to basically make sure that they can get immunized in a timely fashion.”
Those who are eligible will be able to type in their zip code on the Vaccine Finder website, after which it’ll identify the time at which a vaccine is available at their nearest pharmacy, community center and grocery store, among other locations, Brownstein said.
Why were these groups prioritized?
The ACIP has recommended that the first round of COVID-19 vaccines be distributed to health care workers treating COVID-19 patients and older adults living in nursing homes and long-term care facilities because the virus has been especially deadly in these places.
“The advisory group to the CDC says there’s four ethical principles to follow,” explained Dr. Richard Besser, president and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC. “You want to maximize benefits and minimize harms. You want to use a frame of justice, a frame of equity, so those who've been hit the hardest should be in line to get this vaccine early and you want a system that is transparent.”
When these principles are applied, Besser said, health care workers, front-line workers and older people need to be first in line to get the vaccine. They are at the greatest risk of developing severe illness from the virus.
The ACIP has been livestreaming each of its meetings, including those where they vote on prioritization. The general population will likely follow the aforementioned vulnerable groups, and then children and pregnant women will be last.
Eric Strauss, the managing editor of ABC News’ Medical Unit, said it is important to remember that there will not be enough vaccines to vaccinate everyone in the beginning.
“They’re going to start with high-risk individuals [because] there's gonna be limited supply,” said Strauss. “There will not be enough vaccines to vaccinate everybody who wants it.”
In their Dec. 1 meeting, the ACIP noted that while 40 million doses of the vaccine were expected to be available by the end of the year -- enough for 20 million people -- they expect an additional five to 10 million doses to be distributed each week. That said, it could take up to a year for the vaccine to reach everyone.
Why should I trust that the vaccine is safe when it's new and was developed so quickly?
Historically, vaccines have taken years to develop, but with the entire world fighting COVID-19, the three drug makers leading the race to a vaccine -- Pfizer, Moderna and AstraZeneca -- have moved at record speed to produce an effective vaccine. All three have reported higher than 50% efficacy in their vaccines -- the FDA threshold -- with Moderna and Pfizer’s vaccines showing more than 90% efficacy.
“The accelerated timeline is not compromising the safety of the vaccine because all of the steps are still being executed,” said Sony Salzman, coordinating producer of ABC News’ Medical Unit. “They're just happening at a faster pace.”
Besser told ABC News that the size of the federal government’s investment in the vaccine’s development was critical to speeding up the process.
“I'm very critical about the administration's response to the pandemic but one thing I think they've done exactly right is Operation Warp Speed,” said Besser. “The idea of investing upfront in the vaccines before you even know if any of them are gonna be effective allowed every major pharmaceutical company to move into this space and then race to create a safe and effective vaccine.”
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House Coronavirus Task Force, told ABC News that previous research on vaccine development also helped accelerate the process.
“It really is a testimony to years of previous research that got applied in an almost emergency way to an unprecedented historic pandemic,” Fauci told ABC News. “And that's why we have the vaccine that we have right now.”
“The speed is merely a reflection of the extraordinary [and] exquisite nature of the scientific advances in vaccine platform technology and in structure-based vaccine design,” added Fauci. “No safety was compromised and no scientific integrity was compromised. We were just able to do it at unprecedented speed.”
How much will it cost?
Regardless of if you have health insurance, the COVID-19 vaccine will be free for all Americans, according to the Centers for Medicare and Medicaid Services. In October, the agency announced that it will pay for any COVID-19 vaccine that is authorized or approved by the FDA to allow for "broad vaccine access and coverage for all Americans."
Any vaccine or therapeutic doses purchased with U.S. taxpayer dollars will be given to the American people at no cost, the government website for Operation Warp Speed also states. Nevertheless, vaccination providers can still charge an administration fee for giving the shot to someone.
What are the differences between the vaccines and do I have a choice?
At this time, the World Health Organization says there are over 50 vaccines in development worldwide -- several have reached human trials. The U.S. government has highlighted seven as potentially safe for the American people.
With such a high demand for the vaccine, Gregory Glenn, president of research and development at vaccine development company Novavax, told ABC News that it makes sense for there to be many different kinds in development.
“It just makes a lot of sense to have a big backup plan,” Glenn said. “The need for a number of doses is huge.”
Among all of the vaccines in development around the world, there are four main approaches that are currently being tested in late-stage trials.
Pfizer/BioNTech, which recently received authorization from the FDA, and Moderna, which has submitted vaccine data to the FDA for EUA, are considered genetic-code vaccines. They function by introducing an instruction manual composed of genetic material called messenger RNA, which tells a person’s cells to start churning out a protein normally found on the outside of the virus. The body then senses that protein and activates an immune response.
AstraZeneca-Oxford and Johnson & Johnson’s Janssen are testing viral vector vaccines, which use a different virus as a delivery mechanism to introduce a small amount of COVID-19’s genetic material into a person’s cells, training the immune system to identify and overcome it.
Novavax’s vaccine is considered a subunit vaccine, which is a more traditional method that delivers viral fragments, such as the dead husk of a virus or its disembodied proteins, which trigger an immune response.
Many of the vaccines being tested in China are weakened or inactive vaccines, an older approach in which scientists use either killed or weakened versions of the virus itself to trigger the immune system while also ensuring that it doesn’t cause an infection.
“Early on … the vaccine is gonna be scarce, it's gonna be in short supply,” Besser told ABC News. “So there won't really be much in the way of choice for people in terms of, ‘Wow, which vaccine should I get?’”
However, over time, Besser said that we may discover that certain vaccines work better in different age groups and populations, or in people with different medical conditions, meaning doctors might one day advise their patients individually on which vaccine is best for them.
He also noted that once there are multiple products available, people will have to make sure that the second dose of the vaccine they take is the same type of vaccine as the first one.
Who should get the vaccine?
While it might be some time from now, the government’s objective is to make the vaccine widely available to everyone in the general population as soon as possible. Officials are hoping to have enough doses of the vaccine by the spring so that any American who wants it can get it.
“The goal is for everyone to be able to easily get a COVID-19 vaccine as soon as large quantities are available,” the CDC has said.
The CDC has not commented on whether people who have previously contracted the virus should get the vaccine, since there is not yet enough information regarding how long COVID-19 antibodies may protect a person before they wear off.
As is typical in vaccine development, the vaccine is first being studied in healthy adults before developers move on to broader populations, like children and anyone who is pregnant.
The ACIP has stated that once the COVID-19 vaccines are authorized, they will not be recommended for pregnant people, since this group has not been actively included in the late-stage clinical trials. Pregnant people can discuss their options with their physicians so that they make informed decisions about whether or not to receive a vaccination.
Similarly, the ACIP’s recommendations won’t apply to children, as it’s still unknown how the vaccines will work in them. Pfizer broadened its trials to start testing children as young as 12 in November and Moderna followed suit this month. Some doctors are predicting that there could be a COVID-19 vaccine available for children by mid-to-late 2021.
Are undocumented immigrants who get the vaccine at risk of being identified or deported?
Some officials have started to raise the alarm on the potential complications undocumented immigrants might face when trying to access the vaccine.
On Dec. 1, New York Gov. Andrew Cuomo and a coalition of advocacy groups wrote a letter to the U.S. Health and Human Services Secretary Alex Azar on how the federal vaccination program could affect underserved communities and undocumented immigrants. Specifically, the letter stated that the program lacks funding for “Black, Brown, Asian and low-income communities.” Additionally, it raised concerns that undocumented immigrants would be discouraged from taking the vaccine since the federal program initially required people to provide identifying information.
“Time is of the essence as we get closer to the distribution date and I urge the administration to address these issues quickly,” Cuomo said.
In the letter, they proposed an identification system that would track vaccinated individuals, but would not share with the federal government their Social Security number, passport number or driver's license number. They also asked that vaccination identification information be kept private from any non-health agency.
In the wake of Cuomo’s letter, the CDC and HHS announced last week that the federal COVID-19 vaccine program will no longer require states to ask for or share personal information.
“We are thrilled that the CDC and HHS heard our call and removed unnecessary barriers to this life-saving vaccine,” said Murad Awawdeh and Rovika Rajkishun, interim co-executive directors of the New York Immigration Coalition, one of the advocacy groups that signed the letter.
Anu Joshi, the organization’s vice president of policy, said they don’t believe states should be violating people’s rights to patient confidentiality.
“The only agenda that should be driving any federal vaccination program should be the nation's public health and what is our collective health,” Joshi told ABC News. “Creating … completely unnecessary fear and obstacles around a vaccine goes against every single common-sense public health policy.”
Luvia Quinones, health policy director at the Illinois Coalition for Immigrants and Refugee Rights, said they are also working with Illinois Gov. J.B. Pritzker’s administration to ensure that all personal information is kept confidential and only shared with the necessary entities for health purposes.
However, she warned that even if states take action to ensure their residents’ information is protected, beyond immigration enforcement, there are still other fears immigrant communities may have with regard to the vaccine. For that reason, it’ll be important to properly educate these communities about the vaccine.
“Similar to the COVID testing and treatment we've had to do a lot of education and outreach for people to make sure they know and they're not afraid of getting tested or forgoing care out of fear that they're going to get a big hospital bill,” Quinones told ABC News.
Amid the concern that immigrant communities may face barriers in accessing the vaccine, there is still hope.
“It's early. We can still get this right,” said Thomas Saenz, president and general counsel of the Mexican American Legal Defense and Educational Fund.
Saenz said that as the nation tries to defeat the virus, it’s important to consider all populations, including undocumented immigrants. He stressed that our health depends on the health of those around us -- our neighbors, colleagues and everyone we interact within our daily lives.
“There are a lot of immigrants, including undocumented immigrants, who are in front-line jobs doing the important work that's necessary for all of us to survive and we want them to be able to continue to do that work without contracting the illness,” Saenz said. “These are our front-line workers who should be front of the line to receive the vaccine and we have to take the steps to ensure that they can do that.”
When will things get back to normal?
Though it will be a gradual process, a vaccine is a principal step in returning to some semblance of normalcy.
Besser said he looks forward to the morning when he’s able to say this is all over. But for now, he says it’s too soon to say when that will be.
“I hope that by next summer we're able to do a lot more than we can now,” he told ABC News.
BioNTech CEO Ugur Sahin is also hopeful that life will be closer to normal by next summer.
Albert Bourla, CEO of Pfizer, said that in six months, we will be in a “much, much better place,” assuming that the most vulnerable populations are vaccinated, resulting in a dramatic reduction in disease rates and death.
Sahin pointed out that the first vaccines will make a difference for each individual who takes it, but that it won’t change much for the overall population until the uptake of the vaccine is high.
“With … several other companies supplying their vaccines in the … first half of 2021, we could reach about 60% to 70% and could return to normal life [by] end of summer, beginning autumn next year,” he said.
Some doctors caution that it’s impossible to pinpoint exactly when this may be. Brownstein, of Boston Children's Hospital, warned that although we’re assuming things will start slowly rolling back to some sense of normalcy by May or June, the future is still unknown.
“We don't have a crystal ball to know exactly when life will be normal or some version of normal,” he said. “We have to remember that an immunization is not a license to then remove the mask and live your old version of yourself. This is a moment where everyone has to get on board and we have to see the impact of this virus at a population level until we know that we can start to resume normal mobility, normal interactions, normal engagement in day-to-day life, and that could take many months.”
Herd immunity to COVID-19 will occur when enough people have protection from the virus, either from previous infection or vaccination. However, the percentage of people who need to have immunity to COVID-19 in order to achieve herd immunity is still unknown, according to the CDC.
“To me, normal is looking at this in the rearview mirror and not constantly being concerned that we're going to have our loved ones get sick, be in a hospital and, sometimes, even dying,” Fauci said.
Until then, some simple joys of life still remain a long-off dream.
“This time next year,” Novavax’s Glenn said, “maybe we can meet and have a beer … together, without face masks, and look around and see people having their normal life back.”