Coronavirus
Technology Solutions
A Number of Factors will Affect the Impact of
the New Pfizer Vaccine
Pfizer Making Vaccine in Michigan and Belgium
General Public Can Start Receiving Vaccine in
Spring
Vaccine May Only Provide Immunity for a Short
Period
Five Answers to Major Questions
CBC Tests Efficiency of Canadian Masks But Not
Fit
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The Pfizer vaccine could be rolled out so that
by the fall of next year many people around the
globe are immunized. But here are the questions.
·
Can someone who has been vaccinated still
transmit the disease?
·
How long does immunity last? Is it six months or
several years? The fact that it generated immune
response leads some to think that the effect
will be more temporary than with previous
vaccines.
·
Will it be effective with mutations or only the
original?
·
Will there be mutations as there are with
influenza?
·
Are there going to be distribution problems due
to the need to store at minus 94 degrees F?
·
Will significant numbers of people refuse to
take the vaccine?
Pfizer is making the vaccine at facilities in
Kalamazoo, Mich., and Puurs, Belgium. The doses
distributed in the United States will mostly
come from Kalamazoo.
In Kalamazoo, vaccines will go into vials (five
doses per vial). Vials will go into trays (195
vials per tray). Trays will go into specially
designed cooler-type boxes (up to five trays per
box). Pfizer plans to have about 100,000 of the
coolers by the end of this month and more than
double that total by March.
The reusable boxes, each toting between 1,000
and 5,000 doses and stuffed with dry ice, are
equipped with GPS-enabled sensors. Pfizer
employees will be able to monitor the boxes’
locations and temperatures as FedEx and UPS
transport them to hospitals and clinics
nationwide.
The boxes “will have eyes on them at all times”.
Representatives of UPS and FedEx said they had
been planning to play a major role in
distributing vaccines and were ready to go.
Once the Pfizer coolers reach their
destinations, hospitals or pharmacies will have
a few choices of how to store the vaccine. The
easiest option is using ultracold freezers, but
not many sites have them. Otherwise, the
facilities can stash the trays in conventional
freezers for up to five days. Or they can keep
the vials in the cooler for up to 15 days, so
long as they replenish the dry ice and don’t
open it more than twice a day.
General Public Can Start Receiving Vaccine in
Spring
Pfizer released
positive data about
its experimental coronavirus vaccine this week
and may hope to apply for regulatory approval by
the end of the month, but it will take several
weeks more to get a vaccine through the approval
process, experts noted.
Americans should not be hoping for any
authorization from the US Food and Drug
Administration before the last half of December,
experts agreed.
That's because Pfizer, which appears to be the
first company to be getting its vaccine trial
data to the finish line, could not possibly get
it together before the end of next week, which
is already the end of November. After that,
weeks of FDA review remain.
Dr. Larry Corey of the University of Washington
and the Fred Hutchinson Cancer Research Center,
who is leading the coronavirus vaccine trials
network in the United States, told CNN he thinks
it will take about 10 days for the FDA to review
Pfizer's clinical trial data. The agency also
needs to review Pfizer's manufacturing data to
make sure the facilities where the vaccine is
being made are up to standard.
"I'm not sure how long that review will take,
but it could be two weeks. I think that's
reasonable," Corey said.
Then the FDA has committed to seeking input from
the Vaccines and Related Biological Products
Advisory Committee (VRBPAC), an advisory group
that guides the FDA on vaccines.
"Then they'll have to seek the opinion of the
advisory committee, which presumably would be
sometime early in December, I would guess," said
Offit.
The FDA has to publicly schedule any VRBPAC
meeting 15 days in advance, so that could slow
things a little.
It's easy to be confused about what to expect,
with Operation Warp Speed officials promising to
have trucks rolling within a day of an FDA
emergency use authorization (EUA). Plus,
companies have all been manufacturing doses even
as they test the vaccines, with tens of millions
already promised for immediate delivery.
"We want shots in arms within 24 hours," US
Health and Human Services deputy chief of staff
Paul Mango told reporters in October.
But Pfizer's report on Monday -- that it's
vaccine was more than 90% effective --
was preliminary data. It wasn't the information
the company needs to send to the FDA to seek an
EUA.
The FDA has said it wants companies to wait for
two weeks after about half their volunteers have
received a second dose of vaccine before they
apply for that emergency authorization -- and
the doctors running the clinical trials will
have needed to tally about 100 more validated
cases of coronavirus infection to meet the
company's goals for showing the vaccine actually
works.
"They're about a week and a half from that," Dr.
Anthony Fauci, director of the National
Institute of Allergy and Infectious Diseases,
told CNN on Monday.
Even Alex Azar, the secretary of the US
Department of Health and Human Services, has
said the process of getting FDA authorization
will take several weeks.
Dr. Peter Marks, who as head of the FDA's Center
for Biologics Evaluation and Research leads
vaccine decision-making, has said the agency
will move swiftly but will not cut corners. It
will use the EUA process, rather than full
approval -- but that doesn't mean an overnight
approval.
Pfizer has sped up collection of that clinical
data, said Dr. Robert Frenck, director of the
Vaccine Research Center at Cincinnati Children's
Hospital, who is running one of the clinical
trials of the Pfizer vaccine.
"If you look at a more typical vaccine trial
you'd be sending things in batches," Frenck told
CNN Thursday. That's usually a leisurely process
that takes weeks, he said.
But because this is a pandemic, Frenck said his
team is sending Pfizer its data every day. "For
this study they are saying they need information
back in 24 hours," he said. "We are cutting out
the lag time. Because this is an emergency, we
are getting people to work as hard as we can,"
Frenck said.
Pfizer must collect and review the data and
determine whether more people who got placebos
were infected than those who got the actual
vaccine. That information then goes to the FDA
for consideration.
"The data has to be reviewed and confirmed by
FDA," said Dr. Peter Hotez, dean for the
National School of Tropical Medicine at Baylor
College of Medicine. "Sometimes they pick up
things the company might miss," he added.
The FDA will take into account any
recommendations from VRBPAC. At the same time,
the Centers for Disease Control and Prevention's
Advisory Committee on Immunization Practices
(ACIP) will be meeting. FDA gives the
authorization for a vaccine, while ACIP decides
who gets it and when.
Offit said he assumes the two processes will
happen at the same time.
"I would guess we would be seeing this in the
first half of December and the vaccine could, in
theory, be rolling off the shelves by end of
December," Offit said.
There's not yet an official federal government
playbook for who gets vaccinated first, but the
National Academies of Sciences, Engineering and
Medicine, as well as CDC, have recommended that
frontline health care workers, emergency workers
and the most vulnerable who are also most likely
to be infected get the first vaccines.
Companies and the federal government have said
it would be spring at the very soonest before
the general public could expect to get
coronavirus vaccines.
Pandemic-weary residents everywhere are holding
their breath for the first coronavirus vaccines
to be approved by federal regulators. The shots,
currently being mass produced for international
distribution, carry with them the hope of
putting an end to the COVID-19 pandemic and
resuscitating the global economy.
But Dr. Marc Hellerstein, a vaccine researcher
and toxicologist at the University of
California, Berkeley, who studied at MIT, says
he isn’t actually sure if he'll take one of
these early vaccines.
“That’s
a really good question. I might,” he muses. “I’d
be worried though. I’d be worried about – do I
have to get another vaccine in two years?”
Hellerstein is one of a small but vocal
contingent of scientists that are warily
watching the development of the coronavirus
vaccine frontrunners. In general, they have two
theoretical concerns about the first candidates,
which could receive approval from the Food and
Drug Administration sometime within the next
year.
First, these vaccines focus primarily on
creating antibodies – immune defense compounds
that can neutralize the virus. Hellerstein says
that might mean the vaccine’s protection is
short-lived.
“This is what scares me – say you give some
people a vaccine, and it just gets antibodies. A
year later, they’re dying away because that’s
how long these antibodies live. Six months, even
less,” Hellerstein says.
Once those antibodies fade, Hellerstein says
it’s unclear if the immune system will still
recognize the coronavirus and mount a strong
defense. Antibody levels often wane after the
body recovers from an illness, but the immune
system can typically create those antibodies
again quickly if the same pathogen returns. Even
so, Hellerstein argues a vaccine that focuses on
T cells, a type of white blood cell that helps
fight infections, might be more lasting.
In Hellerstein’s own research, he found that T
cells created by the yellow fever vaccine were
still effective decades after the vaccine was
injected. And, Hellerstein adds, when
researchers looked at people who had recovered
from COVID-19, they found those who had only
mild illness had fewer antibodies but more T
cells. Hellerstein thinks that might mean T
cells are more important for fighting off COVID
than antibodies.
“The people with mild infection often don’t have
antibodies at all. Those are the people we want
to emulate. They won. They succeeded,”
Hellerstein says.
Those people also created many different T cells
that targeted different parts of the coronavirus,
but the leading vaccine candidates provide the
body with only one of those targets – the spike
protein. This is the tool the coronavirus uses
to infect and enter cells.
“I would say it’s five different flavors of
vanilla,” says Dr. Anne De Groot, the co-founder
of a vaccine design firm called EpiVax. “The
problem being that if the spike doesn’t work [in
a vaccine], then what do you have?”
Like Hellerstein, she has doubts about the
leading vaccine candidates – especially what she
considers an overcommitment to the spike
protein. If vaccines based on this protein fail
to provide adequate protection against the
coronavirus, then the millions of doses that
companies have already manufactured will end up
in the incinerator. De Groot says that result
would be disastrous for public health and could hinder
subsequent efforts for a better vaccine.
“I think that’s going to have a hugely damaging
effect on public trust in vaccines. So, we
really need to have a plan B,” she says.
De Groot says that plan B should include the
development of vaccines that focus on different
targets and use a variety of strategies in case
one fails, or the coronavirus mutates in a way
that makes the leading vaccines obsolete.
Recently, a mutation was found on the spike
protein in coronavirus cases in Denmark,
although it’s unclear if that mutation will
affect the vaccines’ effectiveness.
Creating more vaccines that focus on other parts
of the virus or increasing the complexity of the
existing vaccines would also stretch out
development time. That’s time we don’t have,
points out Dr. Daniel Barouch, a vaccine
researcher at Harvard University. He also led
the team that designed the Johnson & Johnson
coronavirus vaccine now undergoing clinical
trials.
“It gets exponentially more complicated to add
additional components,” Barouch says. “If you
had 10 years, could you make a better vaccine?
Probably. In terms of what could be done within
the space of a year? Then I think this suite of
vaccines represents the best science the world
has to offer.”
For the short term, Barouch says the spike
protein is the obvious choice for a vaccine.
It’s on the surface of the coronavirus, and
antibodies that can neutralize the protein also
cripple the virus’ ability to attack cells. At
the moment, Barouch says the research suggests a
vaccine targeting the spike protein will likely
work. The presence of antibodies is often used
to help estimate the effectiveness of a vaccine
and measure an immune response. Still, he adds,
nothing is certain until the clinical trials are
complete.
“We won’t know until we see the results. If the
phase 3 studies are wonderfully protective, then
that was clearly a pretty good decision,” he
says. “If they fail, then there’ll be serious
questions.”
Once the first vaccines get federal approval, it
will still take months, at the very least,
before scientists know whether they provide
long-lasting protection. If they prove to be
ineffective or only partially effective, Barouch
says the world will have to wait for the next
generation of vaccines, which will hopefully be
better. Several companies, including De Groot’s
EpiVax in Providence, are working on those
vaccines now.
However, the federal government hasn’t made
those vaccines a priority, says John Lewis, the
CEO of Entos Pharmaceuticals in Canada and San
Diego-based Aegis Life, Inc, which is working on
a coronavirus vaccine. He asked Moncef Slaoui,
the head of the federal government’s main
vaccine development initiative, if he planned to
allocate funding towards diversifying
coronavirus vaccine candidates.
“I said, ‘do you have a plan if spike protein
doesn’t turn out to be ideal, a backup plan to
produce other vaccines?’ And he basically
responded saying, ‘I don’t think we’ll need to
do that,’” Lewis says. “I was disappointed when
I heard that answer.”
Critics argue the government's strategy might
slow down the development of the next generation
of vaccines. But Berkeley’s Hellerstein says if
it turns out the leading vaccines are
just mediocre, they might still be able to slow
down the pandemic enough for new vaccines to
come to the rescue.
“I wouldn’t be surprised if the first vaccines
are OK. Then we buy a little time," he says.
During that time, we should pick a great
vaccine.”
Pfizer says that, as of last week, 94 people out
of about 40,000 in the trial had gotten ill with
COVID-19. While it didn’t say exactly how many
of the sick had been vaccinated, the 90%
efficacy figure suggests it was a very small
number. The Pfizer announcement covers people
who got two shots between July and October. But
it doesn’t indicate how long protection will
last or how often people might need boosters.
“It’s a reasonable bet, but still a gamble that
protection for two or three months is similar to
six months or a year,” said Dr. Paul Offit, a
member of the Food and Drug Administration panel
that is likely to review the vaccine for
approval in December. Normally, vaccines aren’t
licensed until they show they can protect for a
year or two.
The company did not release any safety
information. To date, no serious side effects
have been revealed, and most tend to occur
within six weeks of vaccination. But scientists
will have to keep an eye out for rare effects
such as immune enhancement, a severe illness
brought on by a virus’s interaction with immune
particles in some vaccinated persons, said Dr.
Walt Orenstein, a professor of medicine at Emory
University and former director of the
immunization program at the Centers for Disease
Control and Prevention.
2. Will it protect the most vulnerable?
Pfizer did not disclose what percentage of its
trial volunteers are in the groups
most likely to be hospitalized or to die of
COVID-19 — including people 65 and older and
those with diabetes or obesity. This is a key
point because many vaccines, particularly for
influenza, may fail to protect the elderly
though they protect younger people. “How
representative are those 94 people of the
overall population, especially those most at
risk?” asked Orenstein.
Both the National Academy of Medicine and the
CDC have urged that older people be among the
first groups to receive vaccines. It’s possible
that vaccines under development by Novavax and
Sanofi, which are likely to begin late-phase
clinical trials later this year, may be better
for the elderly, Offit noted. Those vaccines
contain immune-stimulating particles like the
ones contained in the Shingrix vaccine, which is
highly effective in protecting older people
against shingles disease.
3. Can it be rolled out effectively?
The Pfizer vaccine, unlike others in late-stage
testing, must be kept supercooled, on dry ice
around 100 degrees below zero, from the time it
is produced until a few days before it is
injected. The mRNA quickly self-destructs at
higher temperatures. Pfizer has devised an
elaborate system to transport the vaccine by
truck and specially designed cases
4. Could a premature announcement hurt future
vaccines?
There’s presently no way to know whether the
Pfizer vaccine will be the best overall or for
specific age groups. But if the FDA approves it
quickly, that could make it harder for
manufacturers of other vaccines to carry out
their studies. If people are aware that an
effective vaccine exists, they may decline to
enter clinical trials, partly out of concern
they could get a placebo and remain unprotected.
Indeed, it may be unethical to use a placebo in
such trials. Many vaccines will be needed in
order to meet global demand for protection
against COVID-19, so it’s crucial to continue
additional studies.
5. Could the Pfizer study expedite future
vaccines?
Scientists are vitally interested in whether the
small number who received the real vaccine but
still got sick produced lower levels of
antibodies than the vaccinated individuals who
remained well. Blood studies of those people
would help scientists learn whether there is a
“correlate of protection” for COVID-19 — a level
of antibodies that can predict whether someone
is protected from the disease. If they had that
knowledge, public health officials could
determine whether other vaccines under
production were effective without necessarily
having to test them on tens of thousands of
people.
But it’s difficult to build such road maps.
Scientists have never established correlates of
immunity for pertussis, for example, although
vaccines have been used against those bacteria
for nearly a century.
Still, this is good news, said Dr. Joshua
Sharfstein, a vice dean at the Johns Hopkins
Bloomberg School of Public Health and a former
FDA deputy commissioner. He said: “I hope this
makes people realize that we’re not stuck in
this situation forever. There’s hope coming,
whether it’s this vaccine or another.”
Sonovia Mask Will Kill Captured Virus in 30
Minutes
Sonovia’s reusable anti-viral masks are coated
in zinc oxide nano-particles that destroy
bacteria, fungi and viruses, which it says can
help stop the spread of the coronavirus.
Sonovia Mask
The SonoMask displayed an ability to neutralize
the novel coronavirus at an effectiveness of
99.34% within trials performed by the
internationally accredited ATCC Testing
laboratory, Ramat Gan-based Israeli fabric maker
and developer Sonovia announced on Saturday.
Sonovia’s reusable anti-viral masks are coated
in zinc oxide nanoparticles that destroy
bacteria, fungi and viruses, which it says can
help stop the spread of the coronavirus.
"Following this outstanding result – the product
of several months of dedicated anti-viral
sonochemistry formulation – we can now assure
the public that our SonoMask is working
continuously, permanently and rapidly to
neutralize the spread of COVID-19," said Sonovia
CEO Joshua Hershcovici. "We are proud of our
latest accomplishment that will help people feel
safe and protect
their loved ones, all the while remaining the
most ecologically sound option upon the PPE
market."
Sonovia also participated in trials with Adler
Plastic in Italy earlier this year, working
toward creating a solution for carpets and other
types of fabrics. The company boasted a 99.999%
efficiency rate against bacteria during the
pilot testing round.
Furthermore, the Israeli fabric maker has
attracted the cooperation of top brands such as
Gucci, Chanel and Adidas, working on the Fashion
for Good Plug and Play accelerator project – and
earning a $250,000 investment for their
innovation.
"We see our breakthrough technology transforming
our everyday life, implemented in all textiles
surrounding us: from the clothes we wear, to the
textiles in our home, the textiles in our public
spaces, in public transportation and of course
as a protective measure in the workplaces &
medical institutes – in a manner that ensures
safer surroundings during these unusual times,"
said Sonovia's Chief Technology Officer Liat
Goldhammer.
Months into the pandemic, there are still no
standards for consumer masks.So Marketplace opted
to compare more than two-dozen masks to what is
commonly considered the gold standard in
protecting health-care workers from infectious
diseases like COVID-19 — the N95 mask.
Marketplace purchased
the masks in stores and online from a variety of
sellers. The masks were also made out of varying
materials and featured different designs.
Marketplace put
the masks through the rigorous National
Institute for Occupational Safety and Health
tests but they dealt with efficiency and not fit
or breathability.
So it is only a part of the picture
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