Excerpt: "All three have said they will seek regulatory clearance to offer their vaccines to millions of people."
'The vaccines could begin to be distributed as soon as mid-December to those in high-risk groups.' (photo: Artyom Geodakyan/Tass)
25 November 20
In the third such announcement in as many weeks, AstraZeneca revealed Monday that its vaccine candidate, developed by Oxford University, is up to 90 percent effective in clinical trials. Pfizer and its German partner, BioNTech, and Moderna have each reported vaccines that are 95 percent effective in trials.
ll three have said they will seek regulatory clearance to offer their vaccines to millions of people. The drugmakers have moved at record speed, and the first shots of the Pfizer and Moderna vaccines could be given in the coming weeks. The path for the AstraZeneca vaccine is less clear.
What will happen next?
Nov. 9: Pfizer and its German partner, BioNTech, report that their coronavirus vaccine is more than 90 percent effective.
Nov. 16: Moderna reports that its coronavirus vaccine is found to be 95 percent effective
Nov. 20: Pfizer and BioNTech seek emergency authorization.
Nov. 23: AstraZeneca reports that its vaccine is up to 90 percent effective.
Next steps
Companies will apply to federal regulators for authorization to provide the vaccines more broadly.
FDA regulators will review the effectiveness, safety and manufacturing of each vaccine.
An FDA advisory committee will vote on whether to recommend that the agency greenlight each vaccine.
December: The FDA may authorize one or more vaccines.
One or two days later: A Centers for Disease Control and Prevention advisory committee will discuss prioritizing vaccines for high-risk groups.
End of 2020: The government projects that Pfizer and Moderna will provide 40 million doses, enough for 20 million people, by the end of the year. AstraZeneca has said the first 4 million doses could be ready in December, and 40 million could be delivered in the first quarter of 2021.
Why is the FDA using emergency powers to approve a vaccine?
The FDA has emergency authority to issue temporary approvals of medical products to get them to the public more quickly during public health emergencies. Such authorizations require less data and can be done more rapidly than full approvals. Since February, the FDA has used this power to authorize hundreds of coronavirus tests and a few treatments. But it has authorized a vaccine that way only once in its history — in 2005, against anthrax — and that was under sharply different circumstances.
Some experts have expressed qualms about using that process for a coronavirus vaccine that would be given to hundreds of millions of people, but those criticisms have become muted as the pandemic has raged, killing thousands of Americans a week.
Peter Marks, director of the FDA center that oversees vaccines, has vowed to insist on an emergency standard for a vaccine that is roughly equivalent to what’s needed for a full licensure. Even so, the available safety data — two months follow-up on half the trials’ participants after their second shots — is shorter than in traditional trials. And some questions, such as the duration of protection, can’t be answered now — that data will be collected as the trials continue.
When will I be able to get vaccinated?
That depends on your job, your age and your health.
The vaccines could begin to be distributed as soon as mid-December to those in high-risk groups — an estimated 200 million people — who will receive priority, according to a framework devised by an advisory committee to the Centers for Disease Control and Prevention. Government officials said that if both the Pfizer and Moderna vaccines are authorized, they anticipate having enough doses for 20 million people by year’s end.
The exact criteria for who will be first in line will be defined immediately after a vaccine is authorized, but the general principles have been discussed for months. You may qualify for earlier access because of your job: Health-care workers and first responders are likely to be among those prioritized. People who have essential jobs, such as teachers and food workers; those who are at higher risk because of their age; and those who have underlying conditions that increase their risk for severe disease are also likely to receive earlier access.
Healthy younger adults who don’t have medical conditions or high-risk jobs are likely to begin to get vaccinated starting in April, but not everyone will be able to get the shots immediately. And children aren’t even included in most coronavirus vaccine trials — Pfizer is the first company to expand its trial to people 12 and older — so they probably will be among the last to get access.
“I would say starting in April, May, June, July — as we get into the late spring and early summer — that people in the so-called general population, who do not have underlying conditions or other designations that would make them priority, could get” shots, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases.
How will the vaccines be shipped?
The AstraZeneca-Oxford vaccine can be stored at refrigeration temperatures for up to 6 months, which will make it far easier to distribute and administer in much of the world.
The Moderna vaccine is stored frozen at minus-20 degrees Celsius, but it keeps for a month at refrigerator temperatures. This could make it easier to distribute to pharmacies and rural areas that don’t have specialized freezers.
The vaccine from Pfizer and BioNTech must be kept at an ultracold, minus-70 degrees Celsius. The company has created its own GPS-tracked coolers filled with dry ice to distribute it.
Each vial of the Pfizer vaccine holds five doses when diluted. Once thawed, the undiluted vial can be kept in a refrigerator for only five days. A diluted vial can be kept for only six hours before it must be discarded.
How many doses will I need?
The AstraZeneca-Oxford vaccine requires two doses, but the trial found that it was far more effective when the first dose was half the typical dose, with the second given a month later. It remains to be seen which dose the company will submit to regulators for clearance.
Both the Moderna and Pfizer vaccines also require two doses. Pfizer’s booster shot will be given three weeks after the first one; Moderna’s is spaced four weeks later.
How do the vaccines work?
The AstraZeneca-Oxford vaccine uses a harmless cold-causing virus that typically infects chimpanzees to deliver to the body’s cells the genetic code for the spike protein. The cells then make a replica of the spike protein and the immune system learns to recognize the real virus.
The Pfizer and Moderna candidates, if approved, would be the first vaccines using messenger RNA technology ever approved for human use by the Food and Drug Administration. It is different from more traditional vaccines, which often use a weakened or dead version of a virus, or a laboratory-generated protein. Both vaccines use a snippet of the virus’s genetic code to instruct cells to build the spike protein on the surface of the coronavirus, teaching the immune system to recognize the real thing.
How were the vaccines made so fast?
Historically, vaccines have taken years to develop. Before these, the mumps vaccine — which took four years to develop — was the fastest to be approved for use in humans. Developing messenger RNA vaccines like the Pfizer and Moderna candidates has been fast because scientists were able to start their work before there was a known case of the novel coronavirus in this country, using the viral genome shared online as a template. Making messenger RNA vaccines does not require time-consuming steps, such as growing ingredients in chicken eggs.
Are the vaccines safe?
The full safety data haven’t been made available yet, but no serious safety concerns have been reported in either trial. Intensive safety monitoring will continue after the vaccines begin to be used. The side-effects profile of the Pfizer vaccine includes pain at the injection site, as well as fatigue, chills and fever. The side effects noted in Moderna’s news release include pain at the injection site, muscle aches and headaches.
Should I still get vaccinated if I already had the coronavirus?
We are still learning how long immunity to the coronavirus lasts, after an infection or a vaccination. Typically, an infection causes better immunity than a vaccine, but not always — the vaccines for tetanus and human papillomavirus, for example, offer better protection than recovering from a natural infection.
The coronavirus vaccine trials did not exclude people who already had been infected, and the full data from those trials may help reveal how the vaccine performed in those people. Until the CDC committee evaluates the full data on any authorized vaccine, the agency won’t make recommendations about whether people who already were infected should receive it.
How much will the vaccines cost?
The federal government has pre-purchased hundreds of millions of vaccine doses with taxpayer money, and vowed to make them available free.
Will I still need to socially distance?
Yes. Even after a vaccine is approved, experts say people will need to wear masks and socially distance — in part because the vaccine doses will be limited, and it will take time to immunize enough of the population to stop the virus from spreading. Experts say the return to normalcy could take many months or longer.
Will I have a choice on which vaccine to take assuming more than one is approved?
Supply will be far short of demand initially, so you are unlikely to be offered options in the near term. Also, the vaccines have different storage and handling requirements making it likely that each administration site will only have one vaccine on hand, at least to start with.
But Kelly Moore of the Immunization Action Coalition believes that once there are plenty of products available, that may change. Moore hopes supply may meet demand by the second half of next year, opening the potential for people to have options, particularly if one vaccine is preferable for certain age groups, for example.
How will I know which vaccine might be best for me?
Experts say they need more data about the vaccines before being able to answer that question, but here’s how the process works: The FDA will authorize each vaccine based on safety and efficacy results. A CDC advisory committee will subsequently make recommendations to health-care providers for how the vaccines may be used, including whether one vaccine may be preferable for certain demographic groups.Claire Hannan, executive director of the Association of Immunization Managers offered the reminder that, as with any other vaccine, it’s best to discuss those recommendations with your health-care provider.
What will happen if I don’t get vaccinated?
Two other vaccines are in the final phase of testing in the United States, and those trials are also moving much faster than expected because of surging coronavirus cases. Two more are expected to begin soon. Later-generation vaccines are also still in development.
The goal is to immunize enough people to achieve herd immunity, when enough people are immune that a disease can no longer spread. The number of people who need to be immunized to reach that milestone will depend on how effective the vaccines are — a factor that won’t be clear until the trials have finished.
Could I be mandated to get the vaccine by my employer?
That’s not likely anytime soon. Vaccines authorized under the FDA’s emergency authority, as these will be at the start, cannot be mandated, said Beth Bell, a member of the federal advisory panel on immunizations that will recommend to the CDC who should get the first doses. There also won’t be enough vaccine for everyone for months. Many employers offer flu vaccines to their employees, but such programs are voluntary in most settings except hospitals.
Eventually, the vaccines probably will be approved under the FDA’s more lengthy licensure rules and will no longer be considered experimental. But even then, requiring a coronavirus vaccine as a condition for returning to the factory floor or office or retail showroom would create the potential for conflicts, said Jennifer B. Rubin, a labor lawyer at the law firm Mintz in San Diego.
“It’s going to create some really interesting political and legal issues about the haves and have-nots,” she said. “What about people working at fast-food restaurants, servers, people who staff gyms? There’s going to be a need for guidance under the circumstances for employers.”
