By WSJ Staff
Pfizer Inc. and its partner, BioNTech SE, have asked the U.S.
Food and Drug Administration to authorize use of their coronavirus
vaccines. Moderna Inc. is getting close to making a similar request
for its shot, and other vaccines could follow. The first rollouts
could begin as soon as December.
Here is what we know and don't know about how, and when, the
vaccine will get to you.
How will the Covid-19 vaccines be approved, and who decides who
will get them?
The FDA will determine whether to authorize Covid-19 vaccines
for use. Decisions might come in December for the Pfizer and
Moderna vaccines. An advisory committee to the U.S. Centers for
Disease Control and Prevention is expected to recommend who should
be first in line for the initial limited number of doses. But
governors can make the final call within their states, Health and
Human Services Secretary Alex Azar said Tuesday.
How will the vaccines be distributed?
The federal government has a contract with McKesson Corp. to be
a centralized distributor of Covid-19 vaccines, with the exception
of Pfizer's. Pfizer has set up its own distribution network.
Federal health officials say initial doses would be shipped within
24 hours of any FDA authorization, and immunizations could begin
within about 48 hours. The federal government also has partnerships
with national pharmacy chains CVS and Walgreens to vaccinate
residents and staff at long-term care facilities.
Some experts say it could take more than 48 hours for dosing to
begin, as hospital workers and others get used to procedures for
opening specialized, temperature-controlled boxes of vaccine vials
and learn the risks and benefits of the shots.
"Many providers are going to need a few days to get it up and
running, if not a week," said Claire Hannan, executive director of
the Association of Immunization Managers, whose members run state,
territorial and local vaccination programs.
What logistics are in place to deliver the vaccines?
McKesson, the centralized distributor for vaccines other than
Pfizer's, also will receive and package kits of medical supplies
needed to administer the Covid-19 vaccine, such as needles and
syringes and alcohol prep pads. It will send the kits and vials of
the vaccine out to pharmacies, doctors' offices and other
facilities, at a minimum of 100 doses per order, based on order
information supplied by the CDC.
Pfizer plans to use its own distribution centers and ship its
vaccine in specially designed reusable containers that can keep
thousands of doses at the ultracold temperatures required for
How many doses will be available at first?
The initial expected supply immediately after authorization is
about 6.4 million doses, according to Gen. Gustave Perna, chief
operating officer of the U.S. government's Operation Warp Speed
initiative. Including that initial supply, federal officials have
estimated there would be enough doses to vaccinate 20 million
Americans in December.
How many doses will be available next year?
Federal officials have estimated there could be enough to
vaccinate about 25 million to 30 million people a month starting in
Who will get the first doses?
The first doses are likely to go to health-care professionals,
workers in essential jobs, nursing-home residents, older Americans
and people with underlying conditions that put them at high risk.
Exactly which of those groups goes first would depend in part on
the particular vaccine and what its data show about effectiveness
among different age groups or health conditions.
The CDC plans to recommend who to give priority to based on
input from an advisory committee of medical and public-health
experts after the FDA approves each vaccine. Governors can make
decisions about who goes first in their states.
Is there any debate about who should get vaccinated first?
Yes. Some health officials and experts believe health-care
workers should receive the first doses, while others are advocating
for the most vulnerable -- older Americans -- to be first in
The vaccine panel advising the CDC is considering recommending
that about 3 million elderly people in congregate settings like
nursing homes be part of the first phase of immunization along with
about 21 million health workers. The committee also has proposed
putting essential workers such as teachers and police ahead of
adults with high-risk medical conditions and people ages 65 and
over who aren't in congregate settings.
When can the general public expect to have access?
Mr. Azar said he expects there to be enough vaccine doses
starting in the second quarter of 2021 so that anyone who wants a
vaccine can get it. Other federal health officials have said in the
spring or summer. The timeline could change if manufacturing
doesn't go as planned.
How will vaccine doses be allocated to U.S. states?
For the initial supplies, the federal government plans to
allocate doses to states proportionally based on the size of their
adult populations. It is unclear how long the federal government
would stick with population-based proportions and how it would
allocate supplies later.
How do states decide to distribute doses?
State, territorial and some local immunization programs, working
with the CDC, have drawn up plans to distribute doses within their
jurisdictions and to conduct vaccination campaigns. These plans
include identifying facilities where vaccination campaigns can be
conducted, enrolling them and ensuring the necessary equipment is
in place to conduct them. States also have estimated their
populations of high-priority groups like health-care workers.
Does the vaccine work the same way in all population groups?
Pfizer and Moderna haven't yet provided full breakdowns of
vaccine efficacy by age and race or ethnicity, but the companies
have said efficacy was consistent across these groups.
Does everyone get the same dose regardless of age or other
How many people need to get vaccinated to stop the pandemic in
Moncef Slaoui, chief adviser to Operation Warp Speed, has said
if 70% of the population were immunized, that level would achieve
herd immunity, based on the approximately 95% effectiveness of both
the Pfizer and Moderna vaccines.
A vaccine would need to be at least 80% effective, with about
75% of a population receiving it, to extinguish an epidemic without
any other public-health measures, according to a study published in
October in the American Journal of Preventive Medicine.
Reaching those levels of immunization would require educating
millions of Americans about the safety and effectiveness of
vaccines and confronting a strong antivaccine movement, said Peter
Hotez, a vaccine scientist at the Baylor College of Medicine and an
author of the paper. Those are steps the government hasn't taken
yet, he said. "To use a vaccine to eliminate this virus -- it's a
really high bar," he said.
One open question is how effective the vaccines are at
preventing people from transmitting the virus to others, Dr. Hotez
said. Both vaccines were tested primarily for their effectiveness
at preventing people from becoming ill. They are also being
evaluated for effectiveness at preventing infection regardless of
symptoms, but data on those matters haven't been released yet.
What is herd immunity?
Epidemiologists estimate that between 60% and 70% of a
population needs to develop an immune response to the virus to
reach "herd immunity," a state in which enough people have either
been infected or vaccinated to stop transmission of the virus. Some
epidemiologists say herd immunity to Covid-19 might be achieved at
a lower threshold of 50%.
When the vaccines are widely available, how will I get the
Federal officials say they want to make getting a Covid-19
vaccine as easy as going to a pharmacy to get a flu shot. The
government has formed partnerships with about 60% of U.S.
pharmacies to administer Covid-19 vaccines to the broader
population after high-priority groups are vaccinated. Manufacturers
would ship doses to distributors to get them to hospitals,
pharmacies, nursing homes and other administration sites, as
determined by state and federal plans. Pfizer's vaccine requires
ultracold shipping and storage, while Moderna's can be shipped at
higher -- though still freezing -- temperatures. After thawing,
doses can be kept in refrigerators for certain periods.
How many doses will I need?
Vaccines from Pfizer, Moderna and AstraZeneca PLC are given in
two doses, three or four weeks apart. State officials are planning
to issue reminders to people to come back for their second doses. A
Johnson & Johnson vaccine is being tested as a single dose, but
the company hasn't yet reported how well that works.
How much does it cost? Will insurance cover it?
Both the Trump administration and President-elect Joe Biden have
said the vaccine would be free of charge to all Americans, with
administration fees billed to private or government insurance plans
or to a special government relief fund for the uninsured.
Does it have to be a needle?
The vaccines closest to authorization are given as injections.
Merck & Co. is exploring an oral formulation of a Covid-19
vaccine, but it isn't expected to be available in the near
(END) Dow Jones Newswires
November 25, 2020 16:37 ET (21:37 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.