Coronavirus Technology Solutions
November 13, 2020

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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A Number of Factors will Affect the Impact of the New Pfizer Vaccine

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 Making Vaccine in Michigan and Belgium

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.

Vaccine May Only Provide Immunity for a Short Period

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.” 

Five Answers to Major Questions

1. How long will the vaccine protect patients?

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.

Results from the most recent round of testing showed that the mask has the ability to neutralize fallen traces of SARS-COV-2 within 30 minutes after making contact with the fabric. The SonoMask was also proven to maintain its protective properties throughout 55 wash cycles.

"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.

CBC Tests Efficiency of Canadian Masks But Not Fit

Wearing a mask is critical to reducing the spread of COVID-19, but rigorous tests conducted on behalf of CBC's Marketplace found that while some work very well, others offer little protection from the particles that transmit the novel coronavirus. One type of mask can even spread those particles to others.

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