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Pfizer

The pharmaceutical company Pfizer, creator of one of the most effective vaccines against Covid-19, reached the list prepared by Boston Consulting Group (BCG), dominated by Big Tech.

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April 26, 2021 4 min read

This article was translated from our Spanish edition using AI technologies. Errors may exist due to this process.

Pfizer became the first pharmaceutical company to appear at the top of the Boston Consulting Group (BCG) ranking of the most innovative companies . The creators of one of the Most effective vaccines against Covid-19 reached the exclusive top 10 on the list, led by Apple , Google and Amazon .

Since 2005, BCG has published the 50 Most Innovative Companies ranking, led by Big Tech for the seventh consecutive year. First up is Apple , founded by Steve Jobs ; in the second position is Alphabet , Google’s parent company, and in the third place is Amazon of Jeff Bezos .

They are followed in order by Microsoft , Tesla , Samsung , IBM , Huawei and Sony . In tenth place is the American Pfizer, the first in its field to appear within the top 10 positions of the table.

“More and more companies are driving innovation as one of their priorities, changing the way they set their goals and processes. The novelty is the irruption of the pharmaceutical companies ” , pointed Andrés Anavi , Managing Director and Partner of BCG for Argentina and Chile, quoted by El Financiero .

While Pfizer is the first drugmaker to make the top 10 in the ranking, it also includes Johnson & Johnson (number 20), Moderna (number 42) and AstraZeneca (number 49).

Image via The 50 Most Innovative Companies Over Time by BGG .

The Massachusetts-based consultancy noted that only 20% of companies implemented high-performance innovation systems to achieve their goals.

In this sense, companies that already have new platforms and practices incorporated are up to four times more likely to obtain income from new products, services and business models, compared to those that have not.

Another characteristic of the top 50 companies is that they promote greater ethnic and gender diversity in their leadership . Such is the case with Microsoft, Alibaba , Cisco Systems , Philips and Novartis , Anavi noted.

“We have been analyzing, for several years, the relationship between diversity and innovation,” explained the BCG executive.

“In the report, we asked the question of what comes first: diversity or innovation. To do this, we turn to data from past research and detect clear evidence that diversity drives innovation, and not the other way around, that innovation attracts diversity ” , he explained.

Anavi noted that the performance of the most innovative companies is also reflected in the profits they generated for shareholders .

“This profitability is maintained even if the tech giants are removed from the calculation: the main innovators outperformed the index by 13 percentage points ,” concludes Anavi with reference to the MSCI World Index , a US stock index of private equity funds, debt, stock markets and other tools that measure the financial evolution of markets worldwide.

Given that much momentum is still lacking in this field, the report indicates that more than 60% of companies plan to increase investment in innovation this year.

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Pfizer and BioNTech are asking the FDA to approve a change that would permit storage of their Covid-19 vaccine within a temperature range found in medical-grade freezers.

To be clear, this proposed change doesn’t eliminate the need for ultra-cold temperatures as the vaccine moves throughout the supply chain—temperatures that require specialized equipment. Those storage requirements are a barrier to its distribution because not all facilities have equipment that can achieve the required temperatures. What Pfizer and BioNTech are proposing is that when the vaccine reaches its destination, such as a hospital or pharmacy, it could be stored for up to two weeks at (relatively) warmer freezer temperatures.

The FDA granted emergency use authorization to the messenger RNA vaccine, named Comirnaty, last December. According to the product’s label, the vaccine must be stored in ultra-cold temperatures between minus 112 degrees and minus 76 degrees Fahrenheit (minus 80 degrees and minus 60 degrees Celsius). At those temperatures, the vaccine can last up to six months. Pfizer ships the vaccines in specially designed containers that can be refilled with dry ice every five days. Those containers can serve as temporary storage for up to 30 days.

The vaccine can be stored at refrigerator temperatures for up to five days. Pfizer and BioNTech are asking the FDA to approve an additional option to store the vaccine at minus 13 degrees to 5 degrees Fahrenheit (minus 25 degrees to minus 15 degrees Celsius) for two weeks. That range would put it closer to the storage requirements for the mRNA vaccine from Moderna. The temperature range Pfizer and BioNTech are proposing would be in addition to the five days at refrigerator temperatures that is currently permitted under the authorization.

“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer CEO Albert Bourla said in a prepared statement.

Pfizer and BioNTech are proposing the additional temperature option based on new data about their vaccine’s stability. The data span from the earliest clinical trials up to batches currently in production.

Messenger RNA vaccines are a new technology that employ a snippet of genetic material from the novel coronavirus. This mRNA serve as a blueprint that a cell’s protein-making machinery use make the characteristic spike protein found on the surface of the novel coronavirus. That protein is what triggers an immune response and confers immunity.

Though mRNA vaccines are administered at room temperature, they must be kept at ultra-cold temperatures in the supply chain because mRNA is fragile. The extremely cold temperatures keep the components of the vaccine from breaking down. As mRNA companies study the storage data they have for vaccines, they are getting a better understanding of how long these vaccines can last at certain temperatures. Last November, Moderna released data that it said supported storage of its vaccine at refrigerator temperatures for up to 30 days.

Temperature requirements can be a barrier to the distribution of the vaccine to rural areas, which may not have facilities with appropriate freezers. In that regard, the Johnson & Johnson Covid-19 vaccine is seen as offering an advantage. In addition to requiring only a single shot (both authorized mRNA vaccines require two), the J&J vaccine can be stored at standard refrigerator temperatures. An FDA advisory committee is scheduled to hold a hearing about that vaccine on Feb. 26.

Photo by BioNTech

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Monday, 22 February, marks the official start date of the COVID-19 vaccine rollout in Australia as more than 142,000 Pfizer vaccines touched down at Sydney Airport – an endeavour that has been dubbed Australia’s biggest peacetime operation.

The shipment, delivered by Singapore Airlines cargo, is the first of 20 million doses that the Government has secured as part of the COVID-19 Vaccine and Treatment Strategy.

“It was March the 11th last year that the pandemic was declared and now on Aussie soil we have the Pfizer vaccine and it’s ready to go,” Pfizer’s Medical Director Krishan Thiru told the Today show this morning.

“Our focus is on delivering the vaccine to the points of use where the Government asks us to deliver them. That’s what we’re focused on and that’s what we’ll do.”

The vaccine rollout is due to begin next week with the first Australians to begin receiving the vaccine from 22 February.

“The vaccine has landed and we’re stepping up our fight against the pandemic,” Prime Minister Scott Morrison said.

“Once the final safety checks are completed we can start rolling out the vaccine to our most vulnerable Australians and to our frontline border and health workers.

“The hard work of Australians has meant we’re in an enviable position in our fight against the pandemic, so we’ve been able to take the time to properly assess our vaccine decisions and give our world-class regulator the time they need to review the safety of the jabs.

“While we’re taking the time to get the rollout right, I am confident all Australians who wish to be vaccinated against COVID-19 will receive a vaccine this year.”

Who gets first dibs on the vaccine?

As part of the ‘Phase 1a’ vaccine rollout, 80,000 doses will be administered in the first week. 50,000 doses have been allocated to quarantine and border workers and frontline healthcare workers, while 30,000 are reserved for aged care and disability care staff and residents. 62,000 will be set aside for second doses which will be given 21 days after the first dose.

Supplied: Australian Government

The Government’s goal is to eventually deliver 150,000 jabs per day and have the entire adult population vaccinated by late October.

The vaccine will be administered in hospital ‘hubs’ across Australia as well as in residential aged care and disability facilities.

How will the vaccine be stored?

Logistics company DHL has stepped in to tackle the complex task of getting the vaccine to Australians around the country.

The company will employ a network of 200 portable ultra-low-temperature freezers to ensure the vaccine, which needs to be stored at minus 70 degrees, can be delivered safely.

Dr Thiru said the vaccines had been shipped to Australia on specially-designed thermal shippers and were kept in refrigerated containers.

“Our company has a rich heritage in cold chain vaccine storage and distribution. We’ve so far got a 99.9% success rate from delivering the vaccines from the factory door to where they’re used with the quality and integrity interact,” he said.

Will the vaccine stop virus transmission?

Although the vaccine is designed to protect against COVID-19 and its variants, it is too early to tell if it will stop the transmission of the virus.

“You’d need to see a larger proportion of the population vaccinated before you can tell whether it’s going to stop transmission or not and whether you’re going to see a downturn in the rates,” Dr Thiru said.

He explained that laboratory testing results were promising and indicated that the vaccine could be effective against some of the newer COVID-19 strains including the UK, South African, and Brazilian variants.

“If sometime in the future it becomes apparent it’s not effective, you can easily tweak the formula for the vaccine.”

Why has the vaccine rollout taken so long?

When asked why Australia has been slower than other countries in the vaccination rollout, Dr Thiru explained that “every country’s situation is different.” A vaccine, he said, could not start production until it was given the go-ahead by certain authorities.

“Vaccinations can’t start until the vaccine has been fully and thoroughly evaluated by the independent regulatory agency and approved,” he said.

“The TGA is one of the world’s most respected agencies. They get a full evaluation.

“They didn’t have that emergency situation we’ve seen in some other countries.”

The Therapeutic Goods Administration (TGA) is conducting batch tests on the first of the Pfizer vaccine arrivals to ensure they meet quality standards before they are deployed next week.

“Australians can be reassured this vaccine has gone through rigorous, independent testing by the Therapeutic Goods Administration to ensure it is safe, effective, and manufactured to a high standard,” Minister for Health and Aged Care Greg Hunt said.

“These vaccines will now go through further batch testing to further check for quality and efficacy, ensuring all Australians have confidence in the vaccines they receive.”

Why did Pfizer get first preference?

The Pfizer/BioNTech vaccine is the first to be provisionally approved for use in Australia by the TGA with a 95% efficacy score from a clinical trial last year.

Despite the promising results, there have been ongoing concerns over the vaccine’s safety and effectiveness.

33 Norwegian officials aged 75 and older died a short time after receiving the Pfizer vaccine in mid-January and other countries have since reported further deaths and side effects.

A World Health Organization (WHO) committee said this was “in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals” and that the risk-benefit balance of the vaccine “remains favourable in the elderly.”

The TGA said that, although no concrete link has been established between the deaths and the vaccine, it would work with international authorities and Pfizer to get more information.

Chief Medical Officer Dr Brendan Murphy told Nine News that he was not unduly concerned about the Pfizer vaccine rollout, which he says is part of a “diversified vaccine strategy.”

“That’s why we’ve bought more than one vaccine and I still think the Pfizer vaccine will be okay but we just have to wait and see,” he said.

In addition to the Pfizer vaccine, Australia has approved 53.8 million AstraZeneca vaccine doses and 51 million Novavax vaccine doses.

The Government has also signed up to the international COVAX Facility which provides access to a range of vaccines to immunise up to 50 per cent of the Australian population.

The full press release for the vaccine rollout can be found here.


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Even before there was a vaccine, some seasoned doctors and public health experts warned, Cassandra-like, that its distribution would be “a logistical nightmare.

After Week 1 of the rollout, “nightmare” sounds like an apt description.

Dozens of states say they didn’t receive nearly the number of promised doses. Pfizer says millions of doses sat in its storerooms, because no one from President Donald Trump’s Operation Warp Speed task force told them where to ship them. A number of states have few sites that can handle the ultra-cold storage required for the Pfizer product, so, for example, front-line workers in Georgia have had to travel 40 minutes to get a shot. At some hospitals, residents treating Covid patients protested that they had not received the vaccine while administrators did, even though they work from home and don’t treat patients.

The potential for more chaos is high. Dr. Vivek Murthy, named as the next surgeon general under President-elect Joe Biden, said this week that the Trump administration’s prediction — that the general population would get the vaccine in April — was realistic only if everything went smoothly. He instead predicted wide distribution by summer or fall.

The Trump administration had expressed confidence that the rollout would be smooth, because it was being overseen by a four-star general, Gustave Perna, an expert in logistics. But it turns out that getting fuel, tanks and tents into war-torn mountainous Afghanistan is in many ways simpler than passing out a vaccine in our privatized, profit-focused and highly fragmented medical system. Gen. Perna apologized this week, saying he wanted to “take personal responsibility.” It’s really mostly not his fault.

Throughout the Covid pandemic, the U.S. healthcare system has shown that it is not built for a coordinated pandemic response (among many other things). States took wildly different Covid prevention measures; individual hospitals varied in their ability to face this kind of national disaster; and there were huge regional disparities in test availability — with a slow ramp-up in availability due, at least in some part, because no payment or billing mechanism was established.

Why should vaccine distribution be any different?

In World War II, toymakers were conscripted to make needed military hardware airplane parts, and commercial shipyards to make military transport vessels. The Trump administration has been averse to invoking the Defense Production Act, which could help speed and coordinate the process of vaccine manufacture and distribution. On Tuesday, it indicated it might do so, but only to help Pfizer obtain raw materials that are in short supply, so that the drugmaker could produce — and sell — more vaccines in the United States.

Instead of a central health-directed strategy, we have multiple companies competing to capture their financial piece of the pandemic healthcare pie, each with its patent-protected product as well as its own supply chain and shipping methods.

Add to this bedlam the current decision-tree governing distribution: The Centers for Disease Control and Prevention has made official recommendations about who should get the vaccine first — but throughout the pandemic, many states have felt free to ignore the agency’s suggestions.

Instead, Operation Warp Speed allocated initial doses to the states, depending on population. From there, an inscrutable mix of state officials, public health agencies and lobbyists seem to be determining where the vaccine should go. In some states, counties requested an allotment from the state, and then they tried to accommodate requests from hospitals, which made their individual algorithms for how to dole out the precious cargo. Once it became clear there wasn’t enough vaccine to go around, each entity made its own adjustments.

Some doses are being shipped by FedEx or UPS. But Pfizer — which did not fully participate in Operation Warp Speed — is shipping much of the vaccine itself. In nursing homes, some vaccines will be delivered and administered by employees of CVS and Walgreens, though issues of staffing and consent remain there.

The Moderna vaccine, rolling out this week, will be packaged by the “pharmaceutical services provider” Catalent in Bloomington, Indiana, and then sent to McKesson, a large pharmaceutical logistics and distribution outfit. It has offices in places like Memphis, Tennessee, and Louisville, which are near air hubs for FedEx and UPS, which will ship them out.

Is your head spinning yet?

Looking forward, basic questions remain for 2021: How will essential workers at some risk (transit workers, teachers, grocery store employees) know when it’s their turn? (And it will matter which city you work in.) What about people with chronic illness — and then everyone else? And who administers the vaccine — doctors or the local drugstore?

In Belgium, where many hospitals and doctors are private but work within a significant central organization, residents will get an invitation letter “when it’s their turn.” In Britain, the National Joint Committee on Vaccination has settled on a priority list for vaccinations — those over 80, those who live or work in nursing homes, and healthcare workers at high risk. The National Health Service will let everyone else “know when it’s your turn to get the vaccine ” from the government-run health system.

In the United States, I dread a mad scramble — as in, “Did you hear the CVS on P Street got a shipment?” But this time, it’s not toilet paper.

Combine this vision of disorder with the nation’s high death toll, and it’s not surprising that there is intense jockeying and lobbying — by schools, unions, even people with different types of preexisting diseases — over who should get the vaccine first, second and third. It’s hard to “wait your turn” in a country where there are 200,000 new cases and as many as 2,000 new daily Covid deaths — a tragic per capita order of magnitude higher than in many other developed countries.

So kudos and thanks to the science and the scientists who made the vaccine in record time. I’ll eagerly hold out my arm — so I can see the family and friends and colleagues I’ve missed all these months. If only I can figure out when I’m eligible, and where to go to get it.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Photo credit: Joel Saget, Getty Images

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A second vaccine for Covid-19 has won the blessing of U.S. regulators.

The U.S. Food and Drug Administration on Friday approved for emergency use a vaccine developed by Moderna, a biotech company based in Cambridge, Massachusetts.

The green light comes a week after similar approval was given to a vaccine from New York-based Pfizer and its German partner, BioNTech. That first vaccine is already being deployed on the front lines of a pandemic currently claiming more than 3,000 lives a day in the U.S. and stretching the country’s health care resources to a breaking point.

The approval of Moderna’s vaccine means it, too, will soon join the fight against Covid-19. The U.S. has committed to buying 200 million doses of the vaccine, which is administered in two shots, according to the company. Hospitals are expecting deliveries as soon as next week.

“With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Dr. Stephen M. Hahn said in a statement.

The initial shipment from Moderna is expected to total 5.9 million doses, more than double the initial 2.9 million doses of the Pfizer/BioNTech vaccine.

Further, the Moderna vaccine may pose less of a logistical challenge. Unlike the Pfizer/BioNTech product, it does not need to be stored at extremely low temperatures, enabling it to go more places. 

Moderna plans to make 20 million doses available by the end of December.

“We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” Moderna CEO Stephane Bancel said in a statement. He said the vaccine, while developed quickly, is based on a decade of research.

The Moderna and Pfizer/BioNTech vaccines are based on a similar platform: messenger RNA, which helps human cells create their own antibodies to the Covid-19 virus. Developed in record time, both vaccines are around 95% effective but generate some temporary side effects, including pain at the injection site, fever, joint pain and headaches. Both also require two doses.

More severe reactions are possible as the vaccines are given to a larger population. Two health care workers in Alaska reportedly developed allergic reactions to the Pfizer vaccine, with one requiring hospitalization. This was also observed in the U.K. 

The Pfizer/BioNTech vaccine is approved for use in people 16 and over, though members of an FDA advisory panel questioned whether there was enough evidence to support use in those under 18. The Moderna vaccine is approved for those 18 and over.

The age difference led to different outcomes for the vaccines when they came before an FDA advisory panel comprised of outside experts. Panelists were voting on whether the vaccines’ benefits outweighed the risks. The Pfizer/BioNTech vaccine was cleared on a 17 to four vote, with one abstention, while the Moderna vaccine was cleared unanimously, also with one abstention. The abstention reflected concern about the broad scope of the question up for approval

“I’m very uncomfortable with the language,” said Michael Kurilla, an infectious disease expert and director of the clinical innovation division at the National Center for Advancing Translation Sciences, a part of the National Institutes of Health.

“I think in the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” Kurilla said at the end of the advisory panel meeting on Thursday. “I’m not convinced that for all of those age groups, the benefits do actually outweigh the risks and I would prefer to see it more targeted toward people at high risk of serious and life-threatening Covid disease.”

Another critical question facing the vaccine makers is what to do about people taking part in clinical trials, some of which are expected to last into 2022. The trials are comparing the results in those given the actual vaccine against those given a placebo. Participants are not supposed to know which one they received.

But on a website about their vaccine, Pfizer and BioNTech said they are allowing people who got a placebo in their trial to get the actual vaccine. The offer is limited initially to healthcare workers and nursing-home residents, two groups that have been prioritized for vaccination in the U.S. But it will eventually extend to others. There are nearly 44,000 participants in the Pfizer/BioNTech trial.

Moderna also has a plan for the so-called unblinding of its trial participants, of which there are more than 30,000.

The next vaccine candidates are expected to come before regulators early next year. One candidate is being developed by AstraZeneca and Oxford University. Another is from Johnson & Johnson, which said this week it expects to ask for emergency use authorization in February.

Photo: Michael Burrell, Getty Images

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Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

Under public pressure from President Donald Trump, the U.S. Food and Drug Administration on Friday night approved the country’s first Covid-19 vaccine, paving the way for its distribution as early as the weekend.

The emergency approval follows the vaccine’s endorsement Thursday by an outside advisory panel to the FDA and comes as the Covid-19 pandemic continues to cut a deadly swath through the U.S.

The move, though, sets up another difficult chapter in the fight against Covid-19: distributing the vaccine to millions of Americans, starting with health care workers and nursing-home residents. The vaccine was developed in record time by New York-based drug maker Pfizer and a German partner, BioNTech

The initial shipment will include 2.9 million doses. Overall, Pfizer and BioNTech are expected to provide 100 million doses of the vaccine over the next few months, enough to immunize 50 million people. It’s still unclear how many doses will be available after that, with the companies and the government reportedly at odds over future deliveries

Given the challenges ahead, the FDA’s approval was cause for measured celebration.

“While a commercially available Covid-19 vaccine is an important milestone on the road to recovery, mass vaccination of the American people represents a monumental effort unlike any we’ve undertaken before,” Andy Brailo, chief customer officer of health care services company Premier Inc., said in a statement. “The distribution and administration of Covid-19 vaccines to the public will be the supply chain and population health challenge of the pandemic.”

It will also represent a public relations challenge, as events leading up to the FDA’s approval renewed fears that the process was being politicized, potentially sowing distrust

In a Friday morning tweet, President Trump publicly lobbied the FDA to act. “Stop playing games and start saving lives!!!” the president wrote. Then, the White House reportedly threatened FDA Commissioner Stephen Hahn to approve the vaccine on Friday or resign. The FDA reportedly had been planning to act Saturday.

Trump announced the approval with a video message on Twitter.

“Today our nation has achieved a medical miracle,” the president said. “We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history.”

In a statement of his own, Hahn played up the scientific rigor underlying the vaccine’s approval.

“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” he said in a statement. “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

But while the vaccine’s benefits have been judged to outweigh its risks, there are some things to be considered. 

Sheba Medical Center’s Dr. Noam Tau, the lead researcher of a recent study assessing the safety of all U.S.-approved vaccines over a twenty year period, believes that no vaccine trial is perfect, and Pfizer’s Phase 3 trials has issues and shortcomings — for instance, the vaccine wasn’t sufficiently tested on some minorities (such as African Americans and Native Americans); not tested on “special populations” (pregnant and lactating women, immunocompromised, patients of 75, children under 16 years old). Further, he added in an email that the endpoint was assessed for symptomatic Covid-19 infection, for which it is 95% efficacious. Efficacy for asymptomatic infections was not tested. These shortcomings should be kept in mind when deciding who should be vaccinated first and in deciding on which populations should be studied next.

Pfizer and BioNTech began a two-year clinical trial of the vaccine in July and announced interim results last month showing it was 90% effective. That was later revised upwards to 95%.

Not surprisingly, the FDA advisory panel questioned whether enough data had been collected on the vaccine’s impact on 16- and 17-year-olds and on pregnant women. Members also questioned whether the vaccine protected against asymptomatic infection, a main channel for spreading Covid-19.

The panel also noted allergic reactions in two British people who had received shots. Most reactions, though, are mild and similar to what happens with other vaccines.

The Pfizer/BioNTech vaccine relies on a relatively new technology known as messenger RNA, which essentially triggers an immune response to Covid-19 without having to inject any of the virus itself. It is given in a series of two shots, 21 days apart.

The distribution challenge begins with the extremely cold temperatures at which the vaccine must be kept: between -60 and -80 degrees Celsius. Questions also have arisen over the medical staff needed to administer vaccines, given the demands of caring for people already sick with Covid-19.

State and health systems have been bracing for the distribution effort, guided in part by recommendations from the U.S. Centers for Disease Control and Prevention.

“While we along with public health officials throughout the country spent countless hours preparing, this mission is fraught with significant challenges that go well beyond just transporting the vaccine from point a to point b,” Pennsylvania Health Secretary Dr. Rachel Levine testified Thursday during a Senate hearing on vaccine transport.

Funding, equity and coordination among the public and private sectors as among the challenges ahead, Levine said, “all confounded by the lack of a coordinated communication strategy to promote confidence in the safety and efficacy of Covid-19 vaccines.”

Next week, an FDA panel will evaluate data from Moderna’s mRNA Covid-19 vaccine. 

“We should remember — no one vaccine, and no one manufacturer will be enough for the US, and definitely not for the whole world’s supply of vaccines,” Dr. Tau said in an email. “This means that the approval of the EUA for Pfizer’s vaccine is not the beginning of the end, but merely an important step towards the end of the beginning of the pandemic. There is a long way to go yet before we are out of the woods, both locally in the US and globally.

Photo: Waldemarus, Getty Images

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Pfizer’s announcement on Monday that its Covid-19 shot appears to keep nine in 10 people from getting the disease sent its stock price rocketing. Many news reports described the vaccine as if it were our deliverance from the pandemic, even though few details were released.

There was certainly something to crow about: Pfizer’s vaccine consists of genetic material called mRNA encased in tiny particles that shuttle it into our cells. From there, it stimulates the immune system to make antibodies that protect against the virus. A similar strategy is employed in other leading Covid-19 vaccine candidates. If mRNA vaccines can protect against Covid-19 and, presumably, other infectious diseases, it will be a momentous piece of news.

“This is a truly historic first,” said Dr. Michael Watson, the former president of Valera, a subsidiary of Moderna, which is currently running advanced trials of its own mRNA vaccine against Covid-19. “We now have a whole new class of vaccines in our hands.”

But historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

So did Pfizer’s stock deserve its double-digit percentage bump? The answers to the following five questions will help us know.

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 to vaccination sites. Public health workers are being trained to handle the vaccine as we speak, but we don’t know for sure how well it will do if containers are left out in the Arizona sun too long. Mishandling the vaccine along the way from factory to patient would render it ineffective, so people who received it could think they were protected when they were not, Offit said.

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.”

Photo: Credit: Geber86, Getty Images

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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