A Brief History of Vaccination
FDA Approves Moderna's RSV Vaccine, Its Second Licensed Product
The Food and Drug Administration on Friday approved Moderna's vaccine to protect older adults against respiratory syncytial virus, or RSV, making this the company's second licensed product.
The Moderna RSV vaccine, which will be marketed under the name mResvia, was approved for adults 60 and older. It is made using the same messenger RNA platform as Moderna's other licensed product, its Covid-19 vaccine Spikevax.
"The FDA approval of our second product, mResvia, builds on the strength and versatility of our mRNA platform," Moderna CEO Stéphane Bancel said in a statement.
RSV can be contracted at any age, but the infection is more likely to trigger severe illness among infants and the elderly. The Centers for Disease Control and Prevention estimates that between 60,000 and 160,000 adults aged 65 and older are hospitalized in an average year for RSV and between 6,000 and 10,000 die from the infection.
The Moderna vaccine arrives on the market a year after two competitors, GSK's Arexvy, and Pfizer's Abrysvo, which were both approved for the same age group. (Pfizer's vaccine has a second approval for pregnant people as well.)
But Moderna said its vaccine is the only one of the three to be packaged in a prefilled syringe, which it argues saves time and cuts the risk of administration errors for pharmacists and other health professionals who administer vaccines.
In a pivotal Phase 3 trial involving nearly 37,000 people in 22 countries, mResvia was shown to have a vaccine efficacy of 83.7% against lower respiratory tract disease caused by RSV.
The company said a follow-up analysis of the primary endpoint was performed during the FDA review; it included cases that started before the primary analysis cut-off date but that were not confirmed until afterward. Those results were similar to the primary analysis, showing a vaccine efficacy of 78.7%, which was not statistically different from the earlier result.
Moderna said there were no serious safety concerns identified during the clinical trials, with injection site pain, fatigue, headache, and muscle and joint pain being the most commonly reported side effects. Importantly, there were no reports of Guillain-Barré syndrome, a form of progressive paralysis from which people generally recover. Both Pfizer and GSK reported cases of GBS in their clinical trials, findings that concerned the expert panel that helps the CDC set recommendations on how licensed vaccines should be used.
The Advisory Committee on Immunization Practices, or ACIP, recommended last year that adults 60 and older could get one of the RSV vaccines, but should discuss the pros and cons with a medical practitioner, forgoing a more emphatic — and perhaps market-boosting — recommendation urging all adults in the eligible age group to get one of the vaccines. An analysis the CDC published this week supported the cause for concern, noting that the rate of reported GBS cases per million doses of vaccine administered was 5.0 cases for the Pfizer product and 1.5 for the GSK. Those rates were both higher than what was seen with Covid vaccines, which were not linked to an increased risk of GBS.
That potential advantage for the Moderna vaccine may be counterbalanced by concerns about the durability of the protection it triggers.
Moderna's statement said follow-up of participants from its trial showed protection lasted over 8.6 months at least. (When a vaccine is new, it takes time to determine how durable its protection is.) But an analysis issued in February by market analysts TD Cowen questioned if the protection conferred by the Moderna shot wanes more quickly than the protection conferred by its competitors. Both the GSK and Pfizer vaccines appear to protect for at least two cold-and-flu seasons.
Before the Moderna vaccine can be put into use, it must receive a recommendation from the CDC, which only issues advice on how a vaccine should be used after the vaccine has been studied and voted on by the ACIP. That group next meets in late June. Health insurance companies use the CDC's recommendation to set their coverage policies.
As Moderna waits to clear the final hurdle to get its RSV vaccine into pharmacies, both GSK and Pfizer have already applied to the FDA for license extensions, arguing the vaccines should be offered to adults under the age of 60 who are at high risk of severe illness from RSV infection.
GSK, which used a priority review voucher to speed its application through the approval process, expects to hear whether Arexvy can be targeted at people 50 and older by June 7. Pfizer is seeking a more ambitious license extension, applying to be able to market Abrysvo to adults 18 and older who are at high risk from RSV.
In the first year of use of these vaccines, the CDC estimates that 24.4% of people aged 60 and older received an RSV vaccine.
Free COVID-19 Vaccines Could Be A Thing Of The Past As Federal Program Is Set To Expire Early
When COVID-19 vaccines entered the commercial market, the federal government introduced a program to make shots accessible to people with limited coverage or no insurance. That program — which provided millions of free shots to low-income people — is now coming to a halt, U.S. Health officials said.
The Bridge Access Program is set to end in August, months earlier than local health departments and health centers expected as pandemic-era funding from Congress is expiring. Biden administration officials are seeking permanent funding so that routine vaccinations can remain free for adults, through a program akin to the long-standing Vaccines for Children program, a Centers for Disease Control and Prevention official said via email.
Leaders at health centers and departments said without the Bridge Access Program, they're worried about how they'll secure funding for vaccines in preparation for the winter respiratory viral season when hospitalizations and deaths tend to increase. Many low-income Americans may be unable to afford vaccines for the novel coronavirus and its myriad variants. Updated vaccines will be formulated to target these strains, but pandemic-era funding will be gone.
Leaders at the National Association for Community Health Centers, a nonprofit advocacy group, said they knew the program was temporary, but were surprised to hear it was ending this August. As looming respiratory illnesses such as flu, RSV and COVID-19 increase in the colder months this year, health centers will continue to immunize people daily, said Sarah Price, the association's director of public health integration, in a statement. "Health centers will either stock these vaccines or refer to resources within their community — with an aim to addressing access barriers and closing the loop," she said.
Since Bridge Access launched in September 2023, it has provided more than 1.4 million free COVID-19 vaccines through retail pharmacies, community health centers and public health departments across the U.S., David Daigle, a Centers for Disease Control and Prevention spokesperson, said in an email. The CDC did not respond to inquiries about whether the agency told health centers and departments the Bridge program would be ending in August.
Vaccine manufacturers Novavax and Pfizer said via email they planned to assess their accessibility options for U.S. Consumers in the wake of this change and help ensure the vaccines were accessible for uninsured and underinsured patients. Moderna did not respond to a request for comment.
The loss of the program has made health officials worry about an uptick in cases.
"This is creating a barrier that could lead to much larger resurgences of COVID," said Dr. Walter Orenstein, associate director at the Emory University Vaccine Center. Orenstein formerly worked as the U.S. National Immunization Program director with the Vaccines for Children program launch in the 1990s and foresees trouble if vaccines are not made more accessible.
"I hope I'm wrong. But I think that (it's) better to remove barriers to access when we have such safe and effective vaccines than to prevent people [who want] those vaccines to get vaccinated."
The U.S. Has reached a record low of uninsured people, the Department of Health and Human Services announced in August. However, about 7.7% of the population, or around 25 million people, still don't have health insurance. Among adults 18 and older, 11% are uninsured.
In addition, millions of adults have less-than-robust health coverage through their employer and many earn too much to qualify for Medicaid. People in this category likely would have had difficulty getting a COVID-19 vaccine without Bridge Access funding.
The vaccine funding is ending as Medicaid is being rolled back across the U.S. Nearly 22 million people who had Medicaid during the pandemic have been disenrolled as of May 10, according to KFF, a nonpartisan health policy organization.
The next round of COVID-19 vaccines — intended to target dominating strains — has not been released.
COVID-19 Vaccine Tracker
Answers to Key Questions About COVID-19 VaccinesTo help answer common vaccine questions, we consulted Dr. Stanley Perlman, a professor at the University of Iowa's Carver College of Medicine and a member of the U.S. Food and Drug Administration's (FDA) vaccine advisory committee, and Angela Shen, a visiting scientist with the Vaccine Education Center at Children's Hospital of Philadelphia.
Click on any of the questions below to see the answers.
(compiled and written by TIME health reporters Jamie Ducharme and Tara Law)
When can I get a vaccine?Now, if you're at least 12 years old.
All three vaccines are widely available for anyone over 18, and the U.S. Food and Drug Administration said kids ages 12 to 18 can get Pfizer-BioNTech's shot.
Where are COVID-19 vaccines available?COVID-19 vaccines are now available in a variety of locations, including pharmacies, hospitals and public clinics. To find an appointment in your area, you can search VaccineFinder.Org, which collects data directly from government agencies.
How much does it cost to get vaccinated?Nothing for the vaccine itself. The federal Operation Warp Speed program funded vaccine development with the intent that they be offered free to all Americans, regardless of insurance status.
The caveat: The facility where you get the vaccine may choose to charge something like an administrative fee.
Can I choose which vaccine I get?Probably. Vaccine supply is now good enough that many clinics stock different types and allow people to choose which one they want.
What are the differences between the shots?Pfizer-BioNTech's shot is initially given in two doses, three weeks apart, and, as of mid-August 2021, had been shown to be 88% effective against hospitalization; for certain people a booster is then recommended six months later. Moderna's shot is given in two doses, four weeks apart, and as of mid-August was 93% effective against hospitalization. Johnson & Johnson's shot is given in one dose, and through mid-August was shown to be 71% effective against hospitalization.
Can pregnant people get the vaccine?Yes. The CDC in August recommended that all pregnant people get vaccinated against COVID-19. The agency said there is no evidence of safety concerns for either mother or baby, and plenty of evidence to suggest that pregnant people who catch COVID-19 are at high risk of severe disease and complications.
Most health groups previously took cautious stances, neither recommending nor advising against vaccination for those who are pregnant. That's because initial COVID-19 vaccine trials enrolled non-pregnant adults, so data on the shots' use in pregnant people were limited. Now that more research has been done, however, experts are confident that the shot's benefits outweigh its risks.
Can kids get the vaccine?In May, the U.S. Food and Drug Administration authorized Pfizer-BioNTech's vaccine for children as young as 12, expanding vaccine access to millions of adolescents across the country. (Moderna and Johnson & Johnson's shots are still authorized only for adults 18 and older.)
Kids younger than 12 are still unable to get a COVID-19 vaccine in the U.S.—but that may change in the next few months. On Sept. 28, Pfizer provided the FDA with safety and efficacy data for a lower-dose version of its vaccine meant for 5- to 11-year-olds, and said it plans to formally ask for emergency-use authorization soon. Based on that timeline, a vaccine for young kids could feasibly be authorized sometime in October or November 2021. Until then, parents will have to help their kids—who have fortunately been mostly spared the worst of COVID-19's effects—take non-vaccine precautions, such as masking and social distancing.
Can kids get the vaccine?In May, the U.S. Food and Drug Administration authorized Pfizer-BioNTech's vaccine for children as young as 12, expanding vaccine access to millions of adolescents across the country. In clinical trials, the shot was 100% effective at preventing symptomatic disease among 12- to 15-year-olds.
Kids younger than 12, however, are still unable to get a COVID-19 vaccine in the U.S. (Moderna and Johnson & Johnson's shots are authorized only for adults 18 and older.) While studies among children of various ages are ongoing, it's not clear when younger kids may become eligible for vaccination.
Until then, parents will have to help their kids—who have fortunately been mostly spared the worst of COVID-19's effects—take non-vaccine precautions, such as masking and social distancing.
Will I be protected if I only get one dose?It depends which vaccine you receive.
If you are vaccinated with the Pfizer-BioNTech or Moderna shots, you will not be fully protected with one dose. Both are designed to be given in two separate doses, a few weeks apart. When you receive the first dose of a two-dose vaccine, it kick-starts your body's immune system; the second significantly strengthens your immune response. Recent research from the CDC says a single dose provides about 80% protection against infection, but "it's a bit of a tenuous 80%," according to National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. In other words, it's not clear how long that protection lasts. (Some recent research suggests at least 10 weeks, but more studies are required.) To get the vaccine's full benefits, you need both doses.
Johnson & Johnson's shot, however, is meant to be given in a single dose. Studies show that it is 85% effective at preventing severe disease.
Can I get a first dose of one vaccine, and a second dose of another?Not in the U.S.—at least not yet. U.S. Researchers are currently studying the effects of mixing and matching vaccine types, but complete data aren't available yet. In the meantime, the CDC says the currently authorized COVID-19 vaccines are "not interchangeable."
However, in its recent authorization of a third dose for moderately to severely immunocompromised people, the CDC did make an exception: "If the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product may be administered" for the third dose.
Meanwhile, there have been a number of studies recently where results suggested that mix-and-match approaches might actually provide an especially strong immune response. And some countries, like Germany, have moved ahead with recommending such approaches.
Do I need to get a booster shot?In August, the White House announced a plan to offer boosters to all adults as early as September. But the plan has changed since then, based on the recommendations of the FDA, CDC and their advisory committees.
The CDC has so far recommended boosters only for certain people. They include:
The CDC also said some people have the option of receiving a booster if they want to based on personal circumstances or preferences. Those groups include:
Boosters aren't currently recommended for anyone else in the U.S., though regulators and CDC officials will soon decide if any Moderna and Johnson & Johnson recipients should also get extra doses.
Meanwhile, many international leaders, including the World Health Organization, have expressed concern about wealthy countries like the U.S. Authorizing third doses while so many in poorer parts of the world have yet to get a single shot.
How will I keep track of which vaccine I got and when?When you get your first dose, you should get a card on which your health care provider will mark the date and brand of the shot. The card will also say when you're due for your second dose.
If you lose your card, don't panic. Many states will also keep searchable records of patients' immunization statuses. Some providers may also use voluntary text message reminder programs to prompt patients to come in for their second dose.
Once I get vaccinated, can I go back to normal life?Under U.S. Centers for Disease Control and Prevention guidelines, fully vaccinated people (those who received their final shot at least two weeks prior) can now go maskless outdoors and travel with minimal risk to themselves.
The spread of the Delta variant, however, led the CDC to reconsider its earlier guidance that fully vaccinated people could go maskless indoors. Now, the agency suggests "If you are fully vaccinated, to maximize protection from the Delta variant and prevent possibly spreading it to others, wear a mask indoors in public if you are in an area of substantial or high transmission."
Those guidelines are based on increasingly promising science that suggests COVID-19 shots slow transmission of the virus, as well as symptomatic illnesses. One recent study found that both two-dose vaccines were 90% effective at stopping not just COVID-19 disease, but also infections. Research is ongoing, but those findings suggest vaccinated people are much less likely to spread the virus than non-vaccinated people.
Will I need to get a booster shot?Currently, the CDC only recommends a third dose for moderately to severely immunocompromised individuals who received a full course of either the Pfizer-BioNTech or Moderna vaccine. The agency does not yet recommend a third shot for anyone outside of that category.
What's confusing is that the Department of Health and Human Services on Aug. 18 announced a plan to offer boosters more widely as early as this fall. It's unclear whether the FDA will make a decision by then due to a number of complexities, including whether they will be authorized for the general public right away, or only for specific categories of higher-risk individuals.
Meanwhile, many international leaders, including the World Health Organization, have expressed concern about wealthy countries like the U.S. Authorizing third doses while so many in poorer parts of the world have yet to get a single shot.
Does the need for booster shots mean the original vaccines aren't working?No. Lots of vaccines either require booster doses or, like the flu shot, are given annually. Scientists have long said the same might end up being true of COVID-19 shots, to ensure they offer the strongest and most durable protection possible.
There are some data, both from vaccine makers and researchers in Israel (which is ahead of the U.S. In its vaccine rollout), to suggest vaccine-derived immunity wanes over time. A booster shot, some experts argue, could bring it back up to full strength.
But there is also lots of data suggesting that vaccines continue to work well even without a booster. As of mid-August, by which time Delta had become the dominant strain in the U.S., all three authorized shots were still at least 70% effective against hospitalization, according to CDC data. A vaccinated person who gets infected is more than 10 times less likely to die or require hospitalization than an unvaccinated person who gets sick, the agency says.
Are boosters the same as the original shots?So far, yes. Pfizer-BioNTech's booster—the only one currently authorized in the U.S.—is the same as the first two doses.
Moderna is testing a few different booster options: a third dose of its original shot, a lower dose of the original shot, a booster specifically designed to fight the Beta variant and a combination of the original and Beta versions. Moderna has submitted data from these studies to the FDA, but the agency has not yet authorized any of the options.
Finally, Johnson & Johnson said in September that, in company studies, an additional dose of its original vaccine seemed to strengthen immune protection. The company said it had submitted some data to the FDA, but the agency has not authorized a Johnson & Johnson booster either.
If my loved one has been vaccinated already, is it safe for me to go visit?Maybe, under guidance from the U.S. Centers for Disease Control and Prevention, which says that fully vaccinated people—those who are at least two weeks out from their second Pfizer-BioNTech or Moderna dose, or the single-dose Johnson & Johnson shot—can visit with unvaccinated people from a single household. The caveat: If you have any risk factors for severe disease, like an underlying health condition, you may want to wait to visit until you're vaccinated. You may also want to skip it if the visit will involve interstate travel, which the CDC still does not recommend for unvaccinated people.
Encouraging evidence suggests the two-dose COVID-19 vaccines are about 90% effective at blocking infections, as well as symptomatic disease. So if your loved one is vaccinated, they seem unlikely to pass on the virus to you. The visit still carries a small amount of risk if you're unvaccinated, but it's pretty safe.
Once both you and your loved one have received both vaccine doses, you can feel even more confident about spending time together indoors and without masks.
How do we know these vaccines were developed safely?Just like any vaccine authorized in the U.S., the Pfizer-BioNTech, Moderna and J&J COVID-19 shots have gone through a rigorous review process by the U.S. Food and Drug Administration, which receives input from its expert vaccine advisory committee. In addition, the Pfizer-BioNTech vaccine received full agency approval in August, a step up from emergency-use authorization that is based on a longer-term review of safety and efficacy data.
The speed of vaccine development shouldn't be cause for concern. It's true that COVID-19 vaccines were developed much faster than typical shots, but that's in part because pharmaceutical companies had massive amounts of government funding and manufacturing support—and because many other research efforts have been put on hold to facilitate vaccine development. Plus, the mRNA technology that underlies Pfizer and Moderna's shots has been studied for years. All of that work helped scientists adapt it quickly for the COVID-19 crisis.
Can I get the shot if I have allergies?During the first month of vaccination in the U.S., there were only 4.5 severe allergic reactions per million doses administered, according to CDC data.
The risk is quite low, but the CDC recommends that anyone with a known allergy to polyethylene glycol, a component of both the Pfizer-BioNTech and Moderna vaccines, or polysorbate, a substance which may cause a similar reaction, avoid vaccination unless they've been cleared by an allergist-immunologist. Johnson & Johnson's vaccine does not contain polyethylene glycol.
People who have experienced allergic reactions after getting other vaccines should consult their doctors prior to vaccination, and alert providers at the vaccination site so they can be monitored for about 30 minutes after getting the shot.
People with other types of allergies—such as to foods, animals or oral medications—can get the shot.
What are the vaccines' side effects?Across brands, common reactions include pain or swelling at the injection site, fatigue, headaches or muscle aches and low-grade fever. For most people, these effects are fairly mild and clear after about a day. For many people, side effects are worse after the second dose than the first.
Some people have also reported less-common side effects, including skin rashes and arm swelling more than a week after vaccination.
Preliminary research suggests that people who get a third vaccine dose experience side effects similar to those reported after their second dose.
If I already had COVID-19, do I need a vaccine?"If you can get a vaccine, you should," Shen says. People who survive a COVID-19 infection do have some immunity to the virus, but studies have come to different conclusions about the strength and length of that protection.
In a study published in March 2021, researchers in Denmark found that COVID-19 survivors had, on average, about 80% protection against reinfection—but getting the disease again was possible. Elderly adults appeared to be at highest risk of reinfection. For people older than 65, a prior infection only provided 47% protection against a future one, the researchers found. A separate study published in April, which looked at U.S. Marines recruits ages 18-20, also found that 10% of those who had COVID-19 later tested positive for it again.
But one paper published in September 2021 found that people who recovered from a severe COVID-19 infection—one that landed them in the hospital—were well-protected against variants that popped up in the future.
The research is still coming together, but advice from experts is clear: getting vaccinated is your best insurance policy, even if you've already had COVID-19.
Will I need a COVID-19 vaccine every year?It's too soon to tell, but it's looking increasingly likely.
A recent study from Pfizer-BioNTech found that its vaccine offered protection for six months, but it's not yet clear if the shots will last even longer than that. Pfizer's CEO recently said people will "likely" need a third dose within a year of their second one, after which the shots could be given annually.
Following up with people who have gotten the vaccines will help determine how often they need to be re-upped.
Can my employer require me to get a COVID-19 vaccine?Yes, and many already have. President Joe Biden has implemented a vaccine mandate for all federal employees, and a number of large employers, including Google, Goldman Sachs and Deloitte have put similar requirements in place. Most workplaces with vaccine requirements also offer a second choice, like regularly submitting to COVID-19 testing, for employees who can't or won't get the shot.
Do I need a COVID-19 shot and a flu shot?Yes. Different viruses cause the seasonal flu and COVID-19. And since it is possible to get both viruses in one season, doctors recommend you get both shots.
If I'm getting a booster, should I bring my old vaccine card?Yes. Some—though probably not all—vaccine providers will want to see a record of your previous shots, and, if you're eligible for a booster dose, proof of a third dose will likely be recorded on the same card that tracked your first two.
That said, CDC director Dr. Rochelle Walensky has said that the CDC is urging vaccine providers not to deny people shots, so it's possible some vaccinators will not ask for documentation, opting instead to ask people to self-attest that they are eligible. And if you lost your card, don't panic. Many states and pharmacies also keep searchable records of patients' immunization statuses, so it shouldn't be a big deal to get a new card.
If I'm vaccinated, do I need to be worried about variants?This spring, vaccines were working so well and case rates were dropping low enough that the CDC relaxed many of its safety guidelines for vaccinated people. The agency said vaccinated people did not need to wear masks indoors and could travel with minimal risk to themselves.
The spread of the Delta variant, however, led the CDC to reconsider its earlier guidance that fully vaccinated people could go maskless indoors. Now, the agency suggests, "If you are fully vaccinated, to maximize protection from the Delta variant and prevent possibly spreading it to others, wear a mask indoors in public if you are in an area of substantial or high transmission."
COVID-19 vaccines still work very well at preventing severe disease and death. Based on data gathered from 21 U.S. Hospitals from March to mid-August 2021, two doses of the Moderna vaccine were 93% effective against COVID-19 hospitalization, followed by two doses of the Pfizer-BioNTech vaccine (88%) and the single-dose Johnson & Johnson vaccine (71%). However, breakthrough infections are possible. And if a vaccinated person gets infected, they are potentially capable of transmitting the virus to others—hence why the CDC is again recommending precautions like masking indoors.
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