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Breast cancer cells

Athenex’s lead drug candidate, an oral formulation of the chemotherapy paclitaxel, is intended to bring patients comparable, if not better, efficacy and fewer side effects than the intravenous version. But the company now faces questions about the drug’s safety in the wake of an FDA rejection.

Buffalo, New York-based Athenex announced the rejection of the cancer drug Monday. According to the company, the regulator recommended the biotech conduct a new clinical trial in metastatic breast cancer patients. The agency also suggested the company take steps to mitigate the drug’s toxicity.

Shares of Athenex fell sharply after the FDA rejection was announced, and closed Monday at $5.46 apiece, down nearly 55% from Friday’s closing stock price.

Paclitaxel, also known as Taxol, is a widely used chemotherapy for treating breast, ovarian, and lung cancers. Intravenous dosing of the drug can cause adverse reactions. To mitigate those effects, cancer patients are given steroids and antihistamines prior to dosing of the chemotherapy. Other side effects of intravenous paclitaxel include nerve damage, hair loss, and neutropenia, which is an abnormally low level of a type of white blood cell called neutrophils. Those side effects may reduce how much of a dose of the chemotherapy a patient can receive.

Athenex’s version of paclitaxel is given in combination with another drug, encequidar. According to the company, this compound blocks a protein in the intestinal wall that limits the absorption of chemotherapies. In results of a Phase 3 study testing Athenex’s oral paclitaxel in patients with metastatic breast cancer, the company reported its drug met the main goal of showing statistically significant improvement in the overall response rate compared against treatment with the IV version of the chemotherapy.

The company also reported that its drug can reach levels in the blood comparable to IV paclitaxel, and for a longer period of time. The company said in securities filings that this capability may translate to a better clinical response to the therapy. In the 402-patient Phase 3 study, Athenex observed a higher tumor response rate along with lower incidence and severity of nerve problems compared to IV paclitaxel.

Athenex said that the agency’s complete response letter cited the risk of an increase in problems related to neutropenia in the oral paclitaxel arm compared with the group treated with the IV formulation. The FDA also expressed concern about how the results of the study primary endpoint were evaluated under blinded independent central review, a group of independent physicians. According to Athenex, the FDA said there may have been “unmeasured bias and influence” on the review.

Speaking on a conference call, CEO Johnson Lau said the company was “surprised and extremely disappointed” by the FDA’s rejection. The neutropenia concerns cited are a known risk of paclitaxel, he said. Lau added that the review remained blinded, was conducted by independent radiologists, and the regulator had not issued any formal warnings flagging problems at the imaging lab.

The FDA’s recommendation that Athenex conduct another clinical trial specified that the study should include patients more representative of the U.S. population. Rudolf Kwan, the company’s chief medical officer, said on the call that none of the clinical trial sites were in the U.S. But he added that the company had discussed the clinical trial design with the regulator, and the single study, as proposed by the company, was understood to be sufficient to support approval if the results were positive.

Lau said that the company plans to request a meeting with the FDA to discuss the letter and clarify the scope of the new clinical trial needed to address the agency’s concerns.

“Whether it requires the whole study be done in U.S., we’ll have to clarify in the meeting,” Lau said.

Though Athenex has a pipeline of clinical-stage cancer therapies, company currently generates most of its revenue from the sales of generic injectable products. In 2020, it reported more than $105 million in product sales, a 73% increase over 2019 sales. In its financial report of fourth quarter 2020 and full-year results, Athenex attributed the revenue increase to growing sales of specialty pharmaceutical products used to treat hospitalized Covid-19 patients. As of Dec. 31, 2020, Athenex had $86.1 million in cash and $138.6 million in short-term investments.

Photo by American Cancer Society/Getty Images

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The FDA has authorized Johnson & Johnson’s Covid-19 vaccine for emergency use, adding a third vaccination option—one that comes with storage and distribution advantages.

The regulatory decision followed the review of an FDA advisory panel, which voted unanimously on Friday to recommend authorization of the vaccine. J&J said it has begun shipping its vaccines to the federal government, which will manage distribution. The company expects to deliver enough vials for the vaccination of more than 20 million people in the U.S. by the end of March, ramping up to 100 million vaccinations by mid-year.

The J&J shot joins the messenger RNA vaccines developed by Moderna and partners Pfizer and BioNTech as the only authorized Covid vaccines in the U.S. The mRNA vaccines must be transported and stored at ultra-cold temperatures well below temperatures of typical medical freezer equipment. However, vaccination sites now have a little more flexibility in how they can store mRNA vaccines. Last week, the FDA approved a request from Pfizer and BioNTech to permit storage of their vaccine at pharmaceutical-grade freezers for up to two weeks.

The J&J vaccine can be transported and stored at refrigerator temperatures, making it a better option for rural areas or vaccination sites that don’t have the specialized freezer equipment required to store the mRNA vaccines. It has the additional advantage of being a single shot, unlike the mRNA vaccines that are given as two doses weeks apart. A single shot avoids the challenges of getting people to return for a second injection.

“The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” Paul Stoffels, J&J’s chief scientific officer, said in a prepared statement. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance.

The J&J vaccine uses a virus to fight a virus. The company’s Janssen subsidiary takes adenovirus, which causes the common cold, and engineers it so that it cannot replicate and does not cause illness. This engineered virus becomes the vehicle that transports into cells a piece of DNA from SARS-CoV-2, the novel coronavirus. Cells use that genetic material to make the spike protein found on the surface of SARS-CoV-2. Those proteins spark the immune response that leads to immunity. This vaccine technology, which J&J calls AdVac, is the basis of the company’s Ebola vaccine, which was approved by the FDA in 2019.

The FDA authorization for J&J’s Covid vaccine was based on results from a global, placebo-controlled Phase 3 study that enrolled nearly 44,000 volunteers. Those participants were followed for a median of eight weeks. The main goal of the study was to evaluate the first occurrence of moderate-to-severe Covid infection with the onset of symptoms after 14 days, and then after the 28-day mark.

Overall, the J&J vaccine was about 67% effective in preventing moderate-to-severe or critical Covid infection after two weeks. After 28 days, the vaccine was about 66% effective at preventing infection. The FDA added that the J&J vaccine was about 77% effective in preventing severe or critical illness two weeks after vaccination. After 28 days, the vaccine was 85% effective in preventing severe or critical illness.

The most common side effects reported from the studies were pain at the injection site, headaches, fatigue, muscle aches, and nausea. The FDA said these side effects were mostly mild to moderate and lasted for a day or two. J&J does not yet have enough data to determine how long protection from the vaccine lasts. The studies conducted to date also do not show whether the vaccine stops people from transmitting the virus. As part of the emergency authorization, J&J must continue to collect data about its vaccine and report and serious adverse events.

The J&J vaccine is given as a 0.5 mL intramuscular injection. The vaccine is shipped in vials, each containing five doses. The company estimates the vaccine will remain stable for two years stored at minus 4 degrees Fahrenheit (minus 20 degrees Celsius). At refrigerator temperatures in the range of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius), the company says the vaccine can be stored for up to three months. The company will deliver the vaccine with the same cold chain currently used to ship its other medicines.

The federal government will manage the allocation and distribution of the J&J vaccine according to guidelines set by the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Johnson & Johnson said that it plans file an application seeking a formal FDA approval later this year. The company is also seeking authorizations for its vaccine in other markets.

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The U.S. is one step closer to making available another Covid-19 vaccine after a panel of experts voted unanimously Friday to recommend emergency use authorization for a shot developed by Johnson & Johnson.

The independent panel, comprised of mostly physicians, voted 22-0 to support the vaccine with no one abstaining. These votes aren’t binding on the FDA, but the agency often follows the recommendations of its panels. A decision could come as early as this weekend. The two Covid vaccines currently cleared for emergency use received their authorizations the day after their respective advisory panel meetings.

The Johnson & Johnson vaccine would offer an alternative to the ones currently available from the Pfizer and BioNtech alliance, and Moderna. Those messenger RNA vaccines must be distributed and stored at ultra-cold temperatures, then thawed before use. Those shots are given as two doses, weeks apart. The J&J vaccine can be kept at refrigerator temperatures. Another key difference is that the J&J jab requires a single shot. Together, those features will make the J&J vaccine easier to distribute to more people in more places through distribution channels that are already in place.

Panel members expressed support for the J&J vaccine, saying that the safety and efficacy data supported its authorization. But panelists also cautioned the public against picking vaccine favorites.

“It’s important that people do not think one vaccine is better than another,” said Cody Meissner, an infectious disease expert and professor of pediatrics at the Tufts University School of Medicine. “There is no preference for one vaccine over another and all vaccines work with what appears to be equal safety and equal efficacy as of this time.”

Emergency authorization is not the same as an approval. Federal law permits the FDA to allow marketing of unapproved medical products for emergency situations, such as a pandemic. Authorizations only last for the duration of the emergency. These authorizations can also be revoked if new data show that the product is not safe or effective. Stanley Perlman, a professor in the departments of microbiology and immunology at the University of Iowa, said that while the clinical studies to date have produced data about the vaccine’s safety and efficacy, it would be “nice to have more.”

The J&J vaccine may be new, but compared to the mRNA vaccines, the technology behind it has bit of a longer track record. J&J vaccine makes it using its AdVac technology, the same platform that produced the company’s Ebola vaccine, which the FDA approved in 2019. The technology takes the virus that causes the common cold and modifies it so it doesn’t cause illness. That engineered virus is the delivery vehicle that ferries into cells a snippet of genetic code for the novel coronavirus’s spike protein. The genetic material serves as the blueprint from which the body’s cells produce spike proteins. The immune system responds by producing antibodies to those proteins, conferring immunity.

The clinical data to date for J&J Covid vaccine covers 44,000 adults from all over the world. In Phase 3 data reported in late January, the vaccine was 66% effective overall in preventing moderate-to-severe infection, 28 days after vaccination. Furthermore, the vaccine showed 85% efficacy in preventing severe disease, and showed complete protection against Covid-related hospitalization and death, also measured at day 28.

Those marks look inferior to the greater than 90% efficacy demonstrated in mRNA vaccine trials. But cross-trial comparisons are difficult and can be misleading because trials have different designs and different goals. Also, the mRNA studies were conducted earlier in the year when there were fewer variants circulating. Public health experts have said that if those vaccines were tested under current conditions, their efficacy rates might be lower, too.

Plans are already underway to gather more data about J&J’s shot, including a study of the vaccine in children and teens. Johan Van Hoof, the global head of the infectious diseases and vaccines for J&J’s Janssen subsidiary, told the advisory panel that a clinical trial testing the vaccine in those 17 and younger is expected to begin this spring. He also said that the company is assessing how the vaccine responds to variants of the novel coronavirus.

Shortly after Friday’s meeting, the FDA issued a statement saying that it would “rapidly work” with J&J toward finalization and issuance of an emergency use authorization. The agency added that it has notified federal partners involved in the allocation and distribution of vaccines, so that they are ready.

Photo: Getty Images, Sezeryadigar

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Johnson & Johnson has formally asked the FDA to allow emergency use of its Covid-19 vaccine as the company seeks to add a third option to the U.S. lineup of vaccines for the novel coronavirus.

The application comes a week after J&J released preliminary data showing 66% overall efficacy in a Phase 3 clinical trial. Those results fall short of the efficacy marks of messenger RNA (mRNA) vaccines from Moderna and Pfizer. But the J&J jab offers advantages compared to those vaccines.

Unlike mRNA vaccines, which are given as two doses weeks apart, J&J’s vaccine is a single shot. Also, the J&J vaccine can be kept at refrigerator temperatures. Both the Moderna and Pfizer vaccines must be kept frozen—Pfizer’s at ultra-cold temperatures. They’re then thawed and temporarily stored at refrigerator temperatures before dosing.

J&J’s vaccine storage requirements are the same as those for most vaccines, making it an easier fit vaccine distribution channels already in place. The company said that if authorized, its vaccine will ship using the same cold chain technologies it uses for transporting other medicines. Of the vaccine candidates that have advanced to late-stage testing, J&J’s is the only one given as a single dose.

Before the FDA decides whether to grant emergency use authorization to the J&J vaccine, the pharma giant’s candidate must be evaluated by an independent advisory committee to the agency that will evaluate the clinical data and discuss the efficacy and safety risks of the shot. The vaccines from both Moderna and Pfizer went through the same step. The J&J meeting is scheduled for Feb. 26.

J&J’s vaccine, developed by the company’s Janssen division, employs a version of the virus that causes the common cold. That virus is modified so it does not cause illness. It’s used to deliver to cells a snippet of the genetic code for the spike protein, which is prominent on the surface of the novel coronavirus. The cells of the body read that genetic material and make copies of the spike protein. The immune system responds to those copies by making antibodies that protect against Covid-19.

AdVac is the same platform Janssen used to develop an Ebola vaccine that was approved by the FDA in 2019. The technology is also the foundation of experimental Zika, RSV, and HIV vaccines. J&J said that the safety profile observed with its Covid-19 vaccine was consistent with other experimental vaccines based on AdVac.

J&J evaluated its Covid-19 vaccine in a Phase 3 study enrolling 43,783 patients. The main goal was to show protection from moderate to severe disease. There were geographic differences in efficacy rates. The vaccine candidate was most protective in the U.S., where efficacy was 72%, the company said. In Latin America, efficacy was 66%; in South Africa, it was 57% effective. While those marks fell short of the efficacy rates demonstrated by the Moderna and Pfizer vaccines, cross trial comparisons are tricky. Also, the J&J studies were done when more variants of the novel coronavirus were circulating compared to when the Moderna and Pfizer vaccines were tested.

Paul Stoffels, J&J’s chief scientific officer, said in a prepared statement that the company has vaccines ready to ship immediately upon receiving emergency authorization.

“With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,” he said.

In addition to the submission to the FDA, J&J is seeking similar authorizations from health agencies in other countries. The company said an application to the European Medicines Agency will be submitted in coming weeks.

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Voyager Therapeutics is losing Neurocrine Biosciences as a research partner on an experimental Parkinson’s disease treatment, the latest in a string of setbacks for the biotech’s efforts to develop gene therapies addressing neurological disorders.

Cambridge, Massachusetts-based Voyager disclosed late Tuesday that Neurocrine provided a termination notice on the Parkinson’s candidate NBlb-1817, which is currently in mid-stage clinical testing. The decision follows the FDA’s December decision to place a clinical hold on that program due to safety concerns.

Termination of the partnership on the Parkinson’s gene therapy will be effective Aug. 2. The collaboration agreement requires Neurocrine to provide 180 days written notice of a termination. The San Diego biotech acknowledged providing that notice in its own regulatory filing. Three other programs covered by the agreement, one for Friedreich’s ataxia and two others in the discovery stage, are not affected by Tuesday’s decision and will continue, Voyager said.

The alliance began in 2019 when San Diego-based Neurocrine pledged $165 million in cash and stock to Voyager. Of the four programs covered by the pact, the Parkinson’s candidate was the most advanced. According to the deal terms, Neurocrine was responsible for funding Phase 2 clinical development. After the study produced data, Voyager held the option to split the rights to the gene therapy with Neurocrine, sharing in further development costs. Alternatively, Voyager could grant its partner full global rights in exchange for milestone payments pegged to sales.

Prior to the Covid-19 pandemic, Neurocrine anticipated advancing the Parkinson’s gene therapy to a pivotal study in the second half of 2020, the company said in its annual report. The pandemic and the clinical hold stalled that timeline.

Voyager uses engineered viruses to deliver gene therapies to the brain. Parkinson’s is characterized by a lack of dopamine, a brain chemical that’s key to controlling muscle movement. Standard treatment includes prescriptions of levodopa, which is converted by a brain enzyme into dopamine.

As Parkinson’s progresses, a patient has less of that key enzyme in parts of the brain where it is needed to convert levodopa to dopamine, Voyager states in its filings. The Parkinson’s candidate is designed to deliver a gene directly into the neurons where dopamine receptors are located, providing the instructions the brain needs to make the key enzyme.

The Parkinson’s gene therapy is administered via a direct injection into the brain. For its amyotrophic lateral sclerosis and Friedreich’s ataxia programs, the company is exploring other approaches, including spinal or intravenous injections.

In its announcement of the end of the partnership in Parkinson’s, Voyager said Neurocine based its decision on a review of its portfolio and the prioritization of other programs in its pipeline. No mention was made about the safety of the Parkinson’s gene therapy. When Voyager disclosed the clinical hold in December, it said that a Neurocrine safety report noted MRI abnormalities in some study participants. It also said the independent board responsible for monitoring the safety of study participants requested a pause on dosing of patients until it could review additional data.

Until the alliance on NBIb-1817 is officially terminated in August, Neurocrine is the company of record for the clinical program. Voyager said that last month, the FDA informed Neurocrine of the information needed to respond to the clinical hold. In addition to an assessment of how the therapy may have contributed to the adverse findings, Voyager said the agency wants a mitigation plan to manage them along with supportive data to justify that the benefit of the therapy outweighs its risks.

Voyager said it will support Neurocrine on any imaging or clinical assessments requested by data safety monitors of the study, as well as any information sought by the FDA. The company added that it is evaluating the financial effect the termination will have on the company and the future of the Parkinson’s program.

The end of the partnership on the Parkinson’s gene therapy marks the second time a company has passed up the opportunity to advance that program. Sanofi was Voyager’s first partner on the experimental therapy, committing $100 million up front in 2015 for rights to several gene therapies for brain disorders. At the time of the deal, the Parkinson’s gene therapy was in early-stage testing. In 2017, Sanofi returned the therapy to Voyager after the biotech declined to amend the original deal to grant the pharma giant a share of the U.S. rights to the program.

The loss of Neurocrine as a partner in Parkinson’s comes a little more than six months after an alliance with AbbVie ended. That partnership focused on developing gene therapies for Alzheimer’s and Parkinson’s. AbbVie terminated the alliance before either program reached Phase 1 testing, at which point Voyager would have become eligible for additional payments from the North Chicago, Illinois-based pharma company.

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The next generation of antibody testing for Covid-19 is beginning to take shape.

Initial tests determined whether someone had or did not have antibodies to the virus’s signature spike protein. A new crop promises to quantify the antibodies, an advance that could be crucial as researchers seek to understand longer-term immunity from the virus, whether acquired through vaccines or natural infection. But that is not the only question out there.

“There’s still a lot to be learned,” said Michael Haydock, a senior director at Informa Pharma Intelligence in London.

For example, he said, researchers don’t know if there is a threshold number of antibodies a person needs to maintain immunity, Haydock said. Quantitative tests could help pinpoint a threshold and track whether antibodies fall below it, potentially necessitating a booster vaccine.

“Measuring that is going to be very important,” Haydock said in a phone interview. Tests also may be able to quantify differences in immune response based on age, race and other factors.

In addition, quantitative tests can be used to assess people who have recovered from Covid-19 and want to donate plasma for use in convalescent plasma therapy, a treatment for the virus. Researchers also may be interested in understanding the response to Covid-19 vaccines among those who are already on therapies that modify their immune systems.

“That’s the nature of this pandemic, that you’re trying to move forward when you have more questions than you have answers. Antibody testing can help answer those questions,” said Sara Barrington, chief commercial officer for Kantaro Biosciences.

The New York-based company offers a quantitative antibody test for Covid-19 using technology developed at Mount Sinai Health System early in the pandemic. Kantaro is a joint venture between Mount Sinai and RenalytixAI, a diagnostics company based in the United Kingdom.

Complicating the issue is the lack of an agreed-upon standard for measuring antibodies. However, clarity is on the horizon.

The World Health Organization is expected to set standards soon, Barrington said in a phone interview.

“With an international standard, you’d be able to compare the results across different tests,” said Erik Lium, Kantaro’s chairman and the chief commercial innovation officer at Mount Sinai.

In November, the Food and Drug Administration approved Kantaro’s test for emergency use. But the approval comes with a qualification: the test, called COVID-SeroKlir, is considered semi-quantitative.

The FDA appears to be waiting for the international standard to be set before declaring tests fully quantitative, Barrington said. However, European regulators are not waiting. They cleared COVID-SeroKlir for use as a fully quantitative test.

Other tests also have won clearance. One was developed by drug maker Roche, based in Basel, Switzerland. Its test – the Elecsys Anti-SARS-CoV-2 S – is being used in a partnership with Covid-19 vaccine maker Moderna to trace antibody responses in vaccine-trial participants. Like Kantaro’s, the Roche test was approved for emergency use as a semi-quantitative test.

Some are looking beyond Covid-19 to other infections.

A group of researchers from Linnaeus University and bioanalysis company Attana, both in Sweden, is developing a quantitative test for Covid-19, as well as the bacteria that causes tetanus.

“Our vision is a general diagnostics platform that is relevant not just at present, during the ongoing pandemic, but one that will also serve a greater, broader purpose in the future” Teodor Aastrup, Attana’s CEO, said in a statement.

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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.

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