Johnson & Johnson vaccine authorized by FDA


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Johnson & Johnson’s one-shot COVID-19 vaccine effective and safe, FDA staff say


Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, US Food and Drug Administration staff said in documents published on Wednesday, paving the way for its approval for emergency use in the US.

The FDA’s panel of independent experts meets on Friday to decide whether to approve the shot. While it is not bound to follow the advice of its experts, the FDA usually does and has authorised vaccines from Pfizer and Moderna.

The FDA’s panel of independent experts will meet later this week to decide whether to approve the Johnson & Johnson shot.Credit:Getty

J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections. It said that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88 per cent efficacy rate.

While asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe COVID-19, the reduction of asymptomatic cases implies the shot can also cut transmission of the disease.

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Coronavirus latest: FDA considers new rules to speed up approvals for vaccines targeting variants


A car stolen from a vaccination site in Florida had vials of the coronavirus shot inside, prompting a nationwide alert in search of the vehicle. Police in Plant City, Florida, said the suspect drove off in the 2018 Hyundai Accent on Wednesday.

Northern Ireland will give students a one-off cash payment of £500 in compensation for the disruption they have suffered during the pandemic, as coronavirus restrictions force most universities in the UK to continue running classes remotely.

New, more infectious Covid-19 variants — including those first identified in the UK and South Africa — have risen to 14 per cent of infections in France from 3.3 per cent on January 8, French prime minister Jean Castex announced on Thursday.

Pakistani cleric Maulana Tahir Ashrafi, who serves as an adviser to Prime Minister Imran Khan, has taken the unusual step of issuing a fatwa, or religious decree, urging Pakistanis to ignore calls to refuse Covid-19 jabs. “I just want people to know there is nothing wrong with taking coronavirus vaccines,” he said.

Ralph Lauren reported a bigger-than-expected sales drop as the US retailer was hit by coronavirus-driven restrictions in Europe and Japan. Fiscal third-quarter revenues fell 18 per cent from a year ago to $1.43bn, just shy of Wall Street expectations for $1.46bn, according to a Refinitiv survey.

New US jobless claims dropped to their lowest level since November. First-time applications for unemployment benefits totalled a seasonally adjusted 779,000 last week, the Department of Labor said on Thursday, compared with economists’ forecast for 830,000.

Tapestry, the luxury conglomerate behind Coach and Kate Spade, has eked out an increase in quarterly profits thanks to limited discounts and strong demand for high-end handbags online and from China. The New York-based group generated net income of $311m in the three months to December 26, a year-on-year increase of 4 per cent.

Quest Diagnostics, the largest laboratory company in the US, plans to return more money to shareholders after reporting record profits thanks to surging demand for Covid-19 test processing. The New Jersey-based company raised its quarterly dividend 10.7 per cent and increased its share buyback authorisation by $1bn after higher demand for virus tests pushed up its fourth-quarter sales 56 per cent to $3bn.

The Bank of England announced on Thursday that it would put active preparations in place so that it could set negative interest rates within six months, but stressed that this was not a signal that its Monetary Policy Committee thought such a move was necessary.

Clorox raised its full-year profit and sales guidance as demand for its bleach and disinfectant wipes remained buoyant amid a pandemic-induced cleaning boom. The US company’s net sales rose 27 per cent to $1.87bn year on year in the three months to the end of December, its fiscal second quarter.

Anxiety levels in the UK population hit a record high during the first national lockdown last year, official figures showed on Thursday. Overall wellbeing fell sharply and, while it improved later in the summer as social activities resumed, even then it remained well below pre-pandemic levels on all measures.

UK consumer spending remained depressed as lockdown measures dragged on in January. Spending on credit and debit cards in the week to January 28 was 32 per cent below its average level last February, and had risen only slightly since the start of England’s third lockdown, according to Bank of England figures.

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Medical center says employee ‘intentionally’ removed 57 vials of Moderna vaccine from fridge. Local police says FDA and FBI helping investigate.


Boxes containing the Moderna COVID-19 vaccine are loaded into a truck for shipping at the McKesson distribution center in Olive Branch, Miss., Sunday, Dec. 20, 2020. AP Photo/Paul Sancya, Pool
  • In a press release issued Wednesday night, Aurora Health said that an employee at their Grifton, Wisconsin, clinic voluntarily removed dozens of vaccines from refrigeration and was fired for doing so.

  • Over the weekend, Aurora initially said the incident was a matter of human error, but issued a new statement after an internal investigation.

  • The Grafton Police Department issued a statement late Wednesday night confirming that the FBI and FDA are assisting with their investigation into the employee.

  • The Moderna vaccine vials can stay at room temperature for up to twelve hours and must be stored at between 36° to 46° Fahrenheit.

An employee at the Aurora Medical Center-Grafton in Wisconsin removed 57 doses of the Moderna vaccine from a clinic refrigerator “intentionally” and did not return them, the company said, forcing it to discard at least 500 doses.

In a press release issued Wednesday, the healthcare provider said that an employee voluntarily removed the vaccines from the fridge and was fired for doing so.

Over the weekend, Aurora initially stated that the incident was a matter of “human error.” 

“We learned that about 50 vials of Moderna vaccine were inadvertently removed from a pharmacy refrigerator overnight,” a spokesperson told WTMJ-TV on Monday. “While some of the vaccine was administered to team members on Dec. 26 within the approved 12-hour post-refrigeration window, unfortunately, most of it had to be discarded due to the temperature storage requirements necessary to maintain its viability.”

But by Wednesday evening, Aurora released a statement that said that after an internal investigation, the employee intentionally removed the vaccines and did not return them.

The incident resulted in more than 500 doses of the vaccine being discarded Aurora Health added.

“We immediately launched an internal review and were led to believe this was caused by inadvertent human error. The individual in question today acknowledged that they intentionally removed the vaccine from refrigeration,” Aurora’s Wednesday statement said. “We have notified appropriate authorities for further investigation. We are more than disappointed that this individual’s actions will result in a delay of more than 500 people receiving their vaccine. This was a violation of our core values, and the individual is no longer employed by us.”

The Moderna vaccine vials can stay at room temperature for up to twelve hours but must be stored at between 36° to 46° Fahrenheit.

Aurora Health Care added that more than 21,000 healthcare workers had received their first of two Moderna injections. 

The Grafton Police Department issued a statement late Wednesday night confirming that the FBI and FDA are assisting with their investigation into the employee.

When reached by Business Insider for comment, an Aurora Health Care spokesperson said more details would be shared tomorrow.

Read the original article on Business Insider





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FDA approves first oral drug for treating adult patients with advanced prostate cancer



Today, the U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.

Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider. This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”


Richard Pazdur, M.D., Director, FDA’s Oncology Center of Excellence and Acting Director, Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research

The American Cancer Society estimates that in 2020, there will have been more than 190,000 cases of prostate cancer in the U.S. One of the treatment options for advanced prostate cancer is androgen deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow. Current FDA-approved treatments of this type are injected or placed as small implants under the skin. Orgovyx is an orally administered treatment that works by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make.

The safety and efficacy of Orgovyx was evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either Orgovyx once daily or injections of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The objective was to determine if Orgovyx achieved and maintained low enough levels of testosterone (castrate levels), by day 29 through end of the treatment course. In the 622 patients who received Orgovyx, the castration rate was 96.7%.

The most common side effects of Orgovyx include: hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes. Concurrent use of Orgovyx with drugs that inhibit P-glycoprotein, which plays a role in pumping toxins out of cells, is contraindicated. Androgen deprivation therapies such as Orgovyx may affect the heart’s electrical properties or cause electrolyte abnormalities, therefore healthcare providers should consider periodic monitoring of electrocardiograms and electrolytes.

Based on findings in animals and the mechanism of action, Orgovyx can cause fetal harm and loss of pregnancy when administered to a pregnant female; it is advised that males with female partners of reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx. Due to the drug’s suppression of the pituitary gonadal system, diagnostic test results of the pituitary gonadotropic and gonadal functions conducted during and after taking Orgovyx may be affected.

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U.S. Food and Drug Administration



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Covid-19 vaccine shortfalls due to confusion over FDA requirements


Workers move boxes containing the Pfizer-BioNTech Covid-19 vaccine as they are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant in Kalamazoo, Michigan on December 13, 2020.

Morry Gash | AFP | Getty Images

Officials with Operation Warp Speed, the U.S. government program to distribute Covid-19 vaccines to Americans, had to slash the number doses for several states due to confusion over the U.S. Food and Drug Administration’s certificate of analysis requirement for vaccine rounds.

The federal government’s error disrupted vaccination distribution plans in at least 14 states and frustrated governors and state health officials who said they were caught off guard upon learning of shipment shortfalls.

Operation Warp Speed has allocated 2 million Pfizer vaccine doses for this coming week’s shipment, after the U.S. shipped 2.9 million doses last week. Officials also plan to send out 5.9 million doses of Moderna’s vaccine this week.

Dr. Moncef Slaoui, chief advisor of Operation Warp Speed, said the agency mistakenly assumed Pfizer’s vaccine was ready to ship when there was actually a two day lag period in which the FDA requires a certificate of analysis on each set of vaccines.

“That lag period has resulted in differences in the plan and what was actually done,” Slaoui said Sunday in an interview on CNN’s “State of the Union.” “We have addressed that and optimize everyday what we are doing.”

The FDA requires a certificate of analysis for each round of Pfizer’s vaccines at least 48 hours prior to distribution, but doesn’t require the certificate to be reviewed prior to shipment. The certificate includes quality control test results and is required with Pfizer’s emergency authorization use under the FDA.

Former GlaxoSmithKline pharmaceutical executive Moncef Slaoui, who will serve as chief adviser on the effort to find a vaccine for the coronavirus disease (COVID-19) pandemic, speaks as President Donald Trump listens during a coronavirus disease response event in the Rose Garden at the White House in Washington.

Kevin Lamarque | Reuters

Operation Warp Speed Chief Operating Officer Gen. Gustave Perna, who is in charge of logistics for sending out the vaccines, repeatedly apologized on Saturday for smaller vaccine deliveries and took responsibility for the “planning error.”

“The mistake I made is not understanding with exactness — again my responsibility — on all the steps that have to occur to make sure the vaccine is releasable,” Perna said at a press briefing.

States that will experience a smaller number doses than expected include Washington state, New Jersey, Virginia, Idaho, Michigan, Connecticut, California, Nevada, Minnesota, Wisconsin, Vermont, Massachusetts, Iowa and Oregon.

Gov. Jay Inslee of Washington said on Thursday that the Centers for Disease Control and Prevention informed him the vaccine allocation for his state was cut by 40% and that other states would have similar shortfalls.

“This is disruptive and frustrating. We need accurate, predictable numbers to plan and ensure on-the-ground success,” Inslee wrote in a tweet. “No explanation was given.”

Pfizer spokeswoman Kim Bencker told CNBC in an emailed statement following Perna’s apology that the company has millions of doses in warehouses ready for shipment once the company receives confirmation from Operation Warp Speed.

“We remain confident in our ability to deliver up to 50 million doses globally this year and up to 1.3 billion next year,” Bencker said.

U.S. Surgeon General Jerome Adams said the vaccine rollout will be the most challenging immunization program in history and warned there will be inconsistencies in the number of doses planned and what is actually allocated.

“This is going to be the most technically, logistically difficult vaccination project of all time,” Adams said Sunday in an interview with CBS’ “Face The Nation.” “We started slow and we are going to continue to increase. The American people should be hopeful about the vaccines but we also need to remain vigilant.”

 CNBC’s Noah Higgins-Dunn contributed reporting



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FDA authorizes Moderna vaccine for emergency use



The vaccine proved nearly 95 percent effective in clinical trials that enrolled 30,000 patients, roughly 40 percent of whom were over the age or 65 or had chronic medical conditions like heart problems and diabetes that made them more vulnerable to the virus.

The FDA authorization now allows its use for people 18 and over. The first coronavirus vaccine to be authorized in the United States, from Pfizer, is authorized for people as young as 16. But FDA warned in both cases that people with serious allergies should not take the vaccines right now. “Roughly five” allergic reactions to the Pfizer shot have been reported since its roll-out Monday, most notably a case in Alaska, FDA’s top vaccine official, Peter Marks told reporters.

While the agency has not isolated the cause just yet, Marks speculated that a shared component in the two vaccines, polyethylene glycol, could be a culprit. The ingredient is commonly used in pharmaceutical preparations and medicines like laxatives, he said.

Nearly 6 million doses of Moderna’s vaccine will be shipped out to 3,285 sites across the country in the first week, General Gustave Perna, chief operating officer of Operation Warp Speed, said Monday.

Like Pfizer’s vaccine, the Moderna shot uses messenger RNA technology that gives cells instruction to recognize and fight the virus. The Trump administration last week doubled its vaccine order from Moderna to 200 million doses after Pfizer said it wouldn’t be able to deliver more vaccine until the third quarter of 2021.

Moderna, a ten-year-old Massachusetts biotechnology company, has never brought a product to market before. But the company developed its potential vaccine within days of learning the virus’ genetic sequence and began working with the National Institutes of Health to put doses into trials. Moderna was the first among dozens of vaccine makers to begin late-stage trials with tens of thousands of volunteers.

It received nearly $1 billion from the U.S. government to develop and study the vaccine.

“I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. I want to thank the NIH and [the National Institute of Allergy and Infectious Diseases] for their scientific leadership,” said Moderna CEO Stéphane Bancel, who added that government funding from Operation Warp Speed and other agencies was “instrumental to accelerating our progress to this point.”

Moderna in May signed a manufacturing contract with Swiss company Lonza AG to produce up to one billion doses of the vaccine in the next year. In the meantime, it is likely to be a cornerstone of the U.S. goal to immunize millions of Americans.

The administration has spent billions to secure as many as 900 million potential vaccine doses from six manufacturers. But several have hit snags that could delay authorization and more options against the pandemic.

“It has been less than a year since the world first learned of SARS-CoV-2 and the terrible disease it can cause,” NIAID Director Anthony Fauci said in a statement. “To have not one but two safe and highly effective COVID-19 vaccines ready for deployment to the American public is truly a remarkable scientific achievement, and a significant step toward ending the pandemic that has caused so much suffering.”



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Moderna Covid vaccine FDA approved for emergency use


The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine — the second approved for use in the U.S. behind Pfizer and BioNTech’s — bolsters the U.S. supply of doses. The potentially lifesaving shots are desperately needed to fend off the pandemic that has taken more than 300,000 American lives and overwhelmed hospitals.

The FDA’s emergency use authorization Friday approves the federal government’s plan to distribute roughly 5.9 million doses of Moderna’s vaccine to 64 states, territories and major cities across the nation next week.

“We likely will see shots in the arm by the very early part of next week, I would hope Monday or Tuesday,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on the “Today” show on Friday morning.

President Donald Trump said in a tweet: “Congratulations, the Moderna vaccine is now available!”

In addition to Moderna’s vaccine, the U.S. also plans to send out 2 million doses of Pfizer’s vaccine after 2.9 million doses were cleared for shipment this week, Gen. Gustave Perna, who oversees logistics for the Operation Warp Speed vaccine project, said Monday. Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is its first-ever FDA authorized product.

“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 Hahn said in a statement.

U.S. officials hope to vaccinate at least 20 million Americans — mostly front-line health-care workers and nursing home residents — by the end of the year. Initial doses will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. The Centers for Disease Control and Prevention has provided states with an outline that recommends prioritizing health workers and nursing homes, but states can distribute the vaccine as they see fit.

Already, states are reporting confusion about vaccine plans. In recent days, state officials said they learned their second shipment of Pfizer’s vaccine would be smaller than expected or delayed. In Florida, for example, Republican Gov. Ron DeSantis said the federal government told him the state would receive 205,000 Pfizer vaccine doses next week and 247,000 the following week. Those shipments are now on hold, DeSantis said at a press conference Tuesday, and it’s unclear when they will arrive.

Moderna’s vaccine, like Pfizer’s, uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response. Late-stage clinical trial data published last month shows Moderna’s vaccine is more than 94% effective in preventing Covid, is safe and appears to fend off severe disease. To achieve maximum effectiveness, the vaccine requires two doses taken four weeks apart.

The FDA has indicated it would authorize a Covid-19 vaccine that’s safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC.

The FDA authorized Moderna’s vaccine for people who are 18 years old and older. Such an authorization from the agency isn’t the same as full approval, which requires more data and can typically take several months longer. Moderna has submitted only two months of follow-up safety data. The agency usually requires six months for full approval and can always revoke an EUA for a drug if it doesn’t work as intended or proves to be unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March, only to revoke it in June after additional data showed it provided “no evidence of benefit” in coronavirus patients.

The FDA’s announcement comes after a key agency advisory panel on Thursday voted 20-0 with one abstention to recommend the vaccine for emergency use. The Vaccines and Related Biological Products Advisory Committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does.

Prior to the vote, some members of the committee stressed that their endorsement of Moderna’s vaccine was not for a full FDA approval, reiterating that the agency will still need to review more data on safety and effectiveness.

At the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health-care workers who took Pfizer’s vaccine. Doran Fink, deputy director of FDA’s division of vaccines and related products applications, said the agency is looking into the issue.

“As we continue to investigate and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “At this point, we don’t have enough data to make a definitive recommendation one way or the other.”

Fatigue, headaches and muscle pain are the most common side effects from Moderna’s vaccine, along with some rare symptoms such as intractable nausea or vomiting and facial swelling that are likely triggered by the shots, according to the FDA. Some side effects were hard to shake, though most resolved within a week, the FDA said. 

The FDA said that, though it is not necessarily a side effect, it recommends monitoring people who get Pfizer’s or Moderna’s vaccine shots for possible cases of Bell’s palsy, a condition that causes sudden freezing or weakness in facial muscles. The agency also noted a higher prevalence of lymphadenopathy, a disease that can produce swollen or enlarged lymph nodes, in Pfizer’s and Moderna’s trials in the vaccine group compared with the placebo groups.

Moderna has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at minus 4 degrees Fahrenheit. By comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week that it will purchase an additional 100 million doses of Moderna’s vaccine. The U.S. entered into an agreement with Moderna in August to acquire 100 million doses for about $1.5 billion. Moderna said that month it was charging $32 to $37 per dose for its vaccine for some customers, under cheaper “pandemic pricing.” The company said it was in discussion for larger volume agreements that will have a lower price.

— CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.



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FDA authorizes 2nd COVID-19 vaccine, giving Moderna green light to ship doses to states


Doses of the vaccine are expected to be shipped next week.

The U.S. Food and Drug Administration has authorized use of a second COVID-19 vaccine for people age of 18 and over, a move that will trigger the shipment of millions more doses to hospitals and nursing homes next week.

Like its competitor Pfizer, the Moderna vaccine was believed to be both safe and highly effective. After tracking some 30,000 volunteers, Moderna estimated it as 94% effective in preventing COVID-19 illness with few serious side effects.

The Moderna vaccine though does not require the same ultra-cold storage, making it more user-friendly, particularly in rural areas that might be less equipped.

The authorization comes after federal advisers — an independent group of infectious disease experts, doctors and scientists — agreed overwhelmingly on Thursday that the benefits of the Moderna vaccine outweighed any potential risks based on trial data. The vote was 20-0 with one abstention.

“I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants,” Moderna CEO Stéphane Bancel said in a statement following the authorization. “We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

As with volunteers who took the Pfizer vaccine, fatigue, headaches and swelling at the injection site were noted.

Unknown still is whether the vaccine stops transmission. The study only looked at whether people became serious ill.

Also unclear is the potential for allergic reactions. A few incidents have been reported following shots of the Pfizer vaccine.

At Thursday’s meeting on Moderna, Dr. Doran Fink, a senior vaccine official at the FDA, said researchers didn’t have all the information. But he noted that “these cases underscore the need to be vigilant during the early stage of the campaign” and communicate those findings to the public.

“I have never been more hopeful that we will eventually turn the corner on this pandemic,” said Rich Besser, a former director of the Centers for Disease Control and Prevention and head of the Robert Wood Johnson Foundation.

The 5.9 million doses shipped from Moderna will be in addition to the 6.4 million doses provided by Pfizer-BioNTech.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Wednesday that people shouldn’t be concerned about having to choose between Moderna and Pfizer. An internal assessment by the FDA already found that the Moderna data showed the benefits likely outweigh the risks.

President Donald Trump, who had incorrectly tweeted earlier in the day that the Moderna vaccine had been “approved,” tweeted after the EUA was granted, “Congratulations, the Moderna vaccine is now available!”



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Panel recommends Moderna vaccine, paving way for FDA authorization


Federal advisers voted overwhelmingly Thursday to recommend the Moderna vaccine for people over the age of 18, clearing a path for government authorization on what would become the nation’s second vaccine to prevent COVID-19.

The panel of independent advisers, called the Vaccines and Related Biological Products Advisory Committee, found that based on evidence of a clinical trial involving 30,400 people, the Moderna two-dose vaccine is safe and likely more than 94% effective in preventing serious illness caused by the virus.

The decision paves the way for a final green light from the U.S. Food and Drug Administration, which in turn triggers the shipping of 5.9 million doses.

“All these vaccines will not be the magic bullet and miraculously reverses all the damage this pandemic has caused. It gives us hope that one day in the not-too-distant future, some semblance of normalcy will be within our reach,” said Robert Wong, a physician at the Veterans Affairs Palo Alto Healthcare System, who spoke during a public comment session.

Wong urged the panel and federal regulators to be “particularly cognizant” of ensuring equitable access among underserved and vulnerable populations that “have been disproportionately exacerbated by this pandemic.”

The independent panel of advisers was asked to vote on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 vaccine outweigh its risks for use in individuals 18 and older?”

The panel voted in favor, 20-0, with one abstention, to recommend the vaccine.

The questions of allergies were raised, following reports of rare reactions to the Pfizer vaccine, including two in Alaska on Wednesday.

Dr. Doran Fink, a senior vaccine official at the FDA, said researchers didn’t have all the information. But he noted that “these cases underscore the need to be vigilant during the early stage of the campaign” and communicate those findings to the public.

Fink said the FDA was working with Pfizer to further revise fact sheets and warnings to health care providers to make clear that any facility administering it “should ensure that medical treatment for managing serious allergic reactions is immediately available.” He said the FDA plans to do the same for Moderna, if it is ultimately authorized as expected.

If authorized, the 5.9 million doses shipped from Moderna would be in addition to the 6.4 million doses provided by Pfizer-BioNTech that started to roll out this week after being the first to get emergency use authorization.

Dr. Anthony Fauci, the nation’s top infectious disease expert, said Wednesday that people shouldn’t be concerned about having to choose between Moderna and Pfizer. An internal assessment by the FDA already found that the Moderna data show the benefits likely outweigh the risks.

“Moderna certainly will be available soon and have the same level of efficacy … the same safety profile and virtually everything the same about that. So it wouldn’t make much difference which of those you take,” Fauci told CNBC’s “Health Returns.”

One primary difference is that Moderna requires fewer specific handling instructions because it does not require ultra-cold storage conditions like the Pfizer-BioNTech vaccine.

Moderna also is seeking authorization for ages 18 and older, whereas Pfizer’s enrollment of older teens in trials this fall paved the way for authorization of anyone 16-plus.

Which sites get the first doses are being decided by state governors and health departments. As recommended by an ethics board, hospitals have been first in line, injecting front-line workers most likely to come in contact with the virus.

Nursing homes also are the priority, although they have been slower to roll out shots because they rely on CVS, Walgreens and other pharmacies that say the logistics are considerable to ensure no dose is wasted.

Florida and West Virginia were among the first to host vaccine clinics at nursing homes on Wednesday, with a nationwide rollout at long-term care facilities expected on Monday.

By February, it’s expected that other seniors living independently – anyone over age 65 – will be able to ask their pharmacy for a vaccination.

A third vaccine also is on the horizon. Johnson & Johnson was expected by early January to know whether its vaccine was effective. If that vaccine comes online as well, that “will help us accelerate even faster coverage of that population,” Slaoui said.

Estimates for the broader population remains March or April, with immunizations complete by June.

“By the time we get into mid, fall of 2021, we can be approaching some level of normality,” he said.

“I would think that would be things like being able to go to theaters, clearly feeling much more comfortable about school, having restaurants open to indoor dining,” Fauci said.

This report was featured in the Thursday, Dec. 17, 2020, episode of “Start Here,” ABC News’ daily news podcast.

“Start Here” offers a straightforward look at the day’s top stories in 20 minutes. Listen for free every weekday on Apple Podcasts, Google Podcasts, Spotify, the ABC News app or wherever you get your podcasts.



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