Tag: Vaccine

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Health

Trump well being officers talk about Pfizer Covid vaccine as U.S. begins administering pictures

Trump health officials discuss Pfizer Covid vaccine as U.S. begins administering shots

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Health and Human Services officials and the Pentagon are holding a joint conference Monday on the Trump administration’s Operation Warp Speed ​​Covid-19 vaccination program as Americans receive some of the first few shots.

The first doses of a Pfizer vaccine with BioNTech were shipped to the US over the weekend. Trucks carrying boxes of vaccine doses left Pfizer’s Kalamazoo, Michigan manufacturing facility on Sunday and should arrive on Monday, according to Pfizer.

New York’s Northwell Health administered the state’s first dose of vaccine just before 9:30 a.m. ET. Sandra Lindsay, a The critical care nurse at the Long Island Jewish Medical Center received the first shot, which earned the audience applause.

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.

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Health

Moderna Covid vaccine unwanted effects: Fatigue, complications, muscle ache

Moderna Covid vaccine side effects: Fatigue, headaches, muscle pain

Tony Potts, a 69-year-old retiree who lives in Ormond Beach, will receive his first injection as a participant in a Moderna-sponsored Phase 3 COVID-19 clinical vaccine trial on August 4, 2020 at Accel Research Sites in DeLand, Florida.

Paul Hennessy | NurPhoto | Getty Images

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s Covid-19 vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling that are likely caused by the gunfire. That is based on new data released Tuesday by Food and Drug Administration.

On the positive side, people over 64, who are also among the most severely affected by the disease, were generally better tolerated than younger people.

Vaccine side effects are common. It’s actually an immune response that indicates the shots are working as intended, doctors say. Many doctors advise the public to prepare for some more severe side effects than usual with the Covid-19 injections than, say, a typical flu shot, and possibly to take a day or two off to recover.

Moderna’s vaccine, which was approved by FDA officials on Tuesday, is more than 94% effective and safe enough to meet agency requirements for an emergency, according to the report. However, the regulator’s analysis found that the vaccine was associated with common and unpleasant, but not necessarily dangerous, side effects.

More than 9 out of 10 participants who received the vaccine felt pain at the injection site, nearly 7 out of 10 felt tired, and about 6 out of 10 had a headache or muscle pain, the FDA said.

More than 44% of people who received the vaccine reported having joint pain and over 43% reported having chills. The FDA found that more serious “serious side effects” occurred in 0.2% to 9.7% of participants, “occurring more often after the second dose than after the first. Like Pfizer’s Covid vaccine that the FDA approved last week, Moderna’s vaccine also requires two shots, separated by a few weeks.

According to the FDA, nearly 15% of vaccine participants had a fever after the first or second dose.

Some side effects were tough to shake, although most were resolved within a week, the FDA said. Less than 6% reported symptoms that lasted for at least a week after the shot, but that were similar to the placebo group. Some of the study participants had a fever that lasted for more than a week. Seven were in the vaccine group and four were given the placebo, the FDA found.

The FDA said there were seven “serious adverse events” in the study, but none of them were fatal. Four were attributed to the vaccine by investigators and Moderna, including persistent nausea and vomiting, facial swelling, and rheumatoid arthritis.

The FDA staff also recommended that people receiving the vaccine be monitored for possible cases of Bell’s palsy. This isn’t necessarily a side effect, but it’s worth looking out for now that four of the 30,000 participants in the study contract this condition, which causes half of your face to fall off.

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Health

Moderna Vaccine Is Extremely Protecting and Prevents Extreme Covid, Knowledge Present

Moderna Vaccine Is Highly Protective and Prevents Severe Covid, Data Show

WASHINGTON – Newly released data confirmed on Tuesday that Moderna’s coronavirus vaccine offers high levels of protection and sets the stage for this week’s emergency approval from federal regulators and beginning its spread across the country.

The Food and Drug Administration intends to approve use of the vaccine on Friday, said people familiar with the agency’s plans. The decision would give millions of Americans access to a second coronavirus vaccine as early as Monday.

The FDA review confirms Moderna’s earlier assessment that the vaccine had an efficacy rate of 94.1 percent in a study of 30,000 people. Side effects, including fever, headache, and fatigue, were uncomfortable but not dangerous, the agency found.

The success of Moderna’s vaccine has become all the more important to fighting the pandemic as other vaccine efforts have stalled. The hopeful news comes at a time with a record number of coronavirus cases overwhelming hospitals and an ever-increasing death toll that hit a bleak milestone of 300,000 on Monday.

The data release is the first step in a public review process that includes a one-day meeting on Thursday by an independent panel of experts. You will hear from Moderna, FDA scientists, and the public before they vote on whether to recommend approval. The panel is expected to vote yes and the FDA generally follows the experts’ recommendations.

Distribution of about six million doses could then begin next week, significantly adding to the millions of doses already developed by Pfizer and BioNTech, the companies that only released the first emergency coronavirus vaccine last Friday . Healthcare workers received the first shots of the Pfizer BioNTech vaccine Monday with an efficacy rate of 95 percent.

The introduction of vaccines has been eagerly anticipated and is one of the most ambitious vaccination campaigns ever carried out in the United States.

Last summer, the federal government signed contracts with Moderna and Pfizer to dispense a total of 200 million cans in the first quarter of 2021. Since both vaccines require two doses, these contracts guaranteed enough doses for 100 million people.

Last week the government announced that it had bought an additional 100 million doses of Moderna for the second quarter, bringing the number of Americans who can be vaccinated to 150 million. That leaves the question of how and when the 180 million or so other Americans will be covered.

Both vaccines are made available to the public free of charge.

Moderna’s vaccine has become a symbol of government scientists’ successes during the pandemic. After China released the genetic sequence of the new virus in early January, scientists from Moderna and the National Institutes of Health were able to focus on designing a vaccine in just two days. Unlike Pfizer, Moderna has a close relationship with Operation Warp Speed, the federal program that seeks to get a vaccine to market quickly. Nearly $ 2.5 billion federal funding helped Moderna buy raw materials, expand its factory, and increase its workforce by 50 percent.

Moderna’s success contrasts with two other high profile projects the US had hoped would increase vaccine supply: one from pharmaceutical companies Sanofi from France and GlaxoSmithKline from the UK and one from Anglo-Swedish drug maker AstraZeneca and the Oxford University.

AstraZeneca and Oxford used two different doses in clinical trials in the UK and Brazil. The effectiveness was 62 percent at one level and 90 percent at the other. These jumbled results have made it unclear when AstraZeneca will have enough data to obtain an emergency clearance.

Meanwhile, Sanofi and GlaxoSmithKline received disappointing results with their vaccine in early clinical trials. While it produced a promising immune response in volunteers under the age of 50, it did not do so in older people. The companies are now planning a series of new studies with a different version of the vaccine. Due to the delay, they are unlikely to provide vaccines before the end of 2021.

Moderna’s vaccine worked equally well in white volunteers and in color communities. There was also no significant difference between protecting men and women or between healthy volunteers and those at risk for severe Covid-19 who developed conditions such as obesity and diabetes. For people aged 65 and over, the study found an estimated effectiveness of 86.4 percent, which is below the overall estimate of 94.1 percent. However, the apparent difference was not statistically significant.

So far, FDA reviews have shown two possible differences between vaccines, but the results may reflect a lack of data more than real differences. The Pfizer BioNTech study showed that the vaccine began protecting against the coronavirus within about 10 days of the first dose. The experiment with the vaccine from Moderna, however, did not show such a noticeable effect after the first dose.

However, in the early days of the Moderna study, there were fewer cases of Covid-19 among study participants, making it more difficult to measure the differences between the vaccinated group and the placebo group. In either case, health officials have said that for both vaccines, two doses are essential for complete protection.

Updated

Dec. 15, 2020 at 9:31 am ET

A second difference concerns the ability to prevent serious diseases. Moderna presented more evidence that its vaccine can, according to the review. In his study, 30 volunteers developed severe cases of Covid. All of them belonged to the placebo group, with no cases among the vaccinated people.

In the Pfizer BioNTech study, the results were less convincing. There were 10 severe cases in the placebo group and one in the vaccinated group. These numbers are too few to assess the vaccine’s ability to prevent serious diseases.

“The data available for these results did not allow firm conclusions,” said the FDA.

The documents released on Tuesday made it clear that side effects were particularly common after the second dose, but usually lasted only one day. Experts say people may need to take a day off after the shot.

During the Moderna trial, researchers also kept an eye out for volunteers who developed new disorders. In a multi-month study of 30,000 volunteers, it is normal for some to have conditions unrelated to the vaccine, health experts say. Comparing the rates between people receiving the vaccine and placebo, as well as general background rates, can help identify serious concerns and eliminate coincidences.

During the Moderna study, three vaccinated participants developed a form of temporary facial paralysis called Bell’s palsy, while one participant on the placebo experienced the same. Bell’s palsy, which can last weeks or longer, can be triggered by viral infections and other causes. Around 40,000 people develop the disease in the United States each year. Years of intensive research have found no evidence that any vaccine routinely recommended in the US causes Bell’s palsy.

In the review released Tuesday, the FDA said, “There is insufficient information currently available to establish a causal relationship with the vaccine.”

The Pfizer BioNTech study identified four cases in the vaccine group, including one in a person with a history of the disorder and none in the placebo group.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said in an interview with JAMA Monday that the cases of Bell’s palsy in the study were most likely not caused by the vaccine and that the apparent difference between the two groups of volunteers was only one reason Random question.

“Our working hypothesis is just that this is an imbalance in the background rates, as we’ve seen in other studies,” he said.

In its analysis of the Moderna vaccine released Tuesday, the FDA said it plans to recommend prosecuting Bell palsy cases when the vaccines are rolled out.

“We’re going to ask about this just to wrap up that question,” said Dr. Marks on Monday.

The FDA’s analysis did not reveal any serious allergic reactions to the Moderna vaccine. The same was true for the Pfizer-BioNTech clinical trial, but when vaccinations began in the UK outside of that study, two people with a history of serious allergies had a severe and potentially life-threatening reaction called anaphylaxis.

UK health officials have said people with a history of anaphylaxis should avoid the Pfizer BioNTech vaccine.

In the United States, the Centers for Disease Control and Prevention has stated that people with serious allergies can be safely vaccinated, with close monitoring for 30 minutes after receiving the shot.

Moderna and Pfizer-BioNTech vaccines are similar in their ingredients, but not identical. Therefore, it is not clear whether an allergic reaction to one vaccine would occur with the other. Both are made up of genetic material called mRNA that is enclosed in a bladder made of a mixture of fats. The two companies use different fats.

Moderna has applied for approval to vaccinate people aged 18 and over, as in its study. The Pfizer BioNTech vaccine was approved for people aged 16 and over because the study included a number of younger volunteers. Both companies are conducting experiments with children aged 12 and over and plan to also study younger children.

Sharon LaFraniere contributed to the coverage.

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Health

Did You Get the Coronavirus Vaccine, or Are You Planning To?

Did You Get the Coronavirus Vaccine, or Are You Planning To?

With the approval of the Food and Drug Administration, Pfizer is shipping doses of its coronavirus vaccine to hospitals across the country this week.

Health care workers have already started taking the pictures and most nursing home residents will have them next week. Other priority groups – likely a combination of key workers, people aged 65 and over, and people at high risk for disease – are expected to gain access sometime in January.

The New York Times reporters writing about the vaccine would like to hear – or try – your experience with the vaccine. We also want to know if receiving a vaccine changes your daily behavior or your attitudes about going out in public and interacting with others.

We will not publish any part of your submission without contacting you first.

Required fields are marked with an asterisk.

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Not all seniors will get Covid vaccine rapidly. Most should wait

Not all seniors will get Covid vaccine quickly. Most will have to wait

Ergin Yalcin | E + | Getty Images

For the nation’s oldest seeking protection from Covid, the waiting game has begun.

Shipments of 2.9 million doses of the first U.S.-approved coronavirus vaccine began on Sunday and resulted in hundreds of locations across the country. Because initial supply is limited – the total US population is around 330 million – the Centers for Disease Control and Prevention recommend that priority be given to healthcare workers and residents of long-term care facilities during this first phase.

In other words, without the elderly in these facilities – including nursing homes and the like – the 65-year-old and the elderly may need to be patient.

“Seniors might start vaccinating in the first quarter, but it really will depend on how quickly the supply increases,” said Jennifer Kates, senior vice president and director of global health and HIV policy for the Kaiser Family Foundation.

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The Food and Drug Administration on Friday approved Pfizer and BioNTech’s coronavirus vaccine for emergency use in people aged 16 and over. One from Moderna could also get similar approval from the FDA in the coming days.

“If the Moderna vaccine gets approved this week, it will help because there will be more coverage,” Kates said.

According to a CDC advisory committee, demand is expected to outstrip supply in the first few months of the vaccination program. Although the vaccine will be phased out and administered to prioritize the most vulnerable populations, it is not certain how long it will take to cover each of these audiences.

According to a new Kaiser study, 19.7 million adults work in the healthcare sector, of which 15.5 million have direct patient contact. Around 2 million people live between nursing homes and assisted living facilities.

Introducing the Pfizer vaccine is a complex federal and state undertaking. Not only does the vaccine need to be stored at subzero temperatures and handled according to strict protocols, but it also requires two doses three weeks apart.

While Medicare – which insures a large proportion of the 65-year-olds and the elderly – recently changed its rules to fully cover a fast-moving vaccine, individual states are tasked with actually distributing the doses and identifying priority populations to be vaccinated. All states generally follow federal recommendations for their initial audiences, Kates said, adding that some have an expanded list of priorities.

What [the advisory committee] In reflection it has been said that they are very likely to recommend that key workers come next, then seniors and those with existing medical conditions.

Jennifer Kates

Senior Vice President at the Kaiser Family Foundation

It is uncertain which groups the CDC will recommend for prioritization after the first round of reporting or whether an earlier target of 20 million people vaccinated by the end of the year will be achieved. However, the Agency’s Advisory Committee on Immunization Practices last month suggested that the next priority population should be people 65 and over, critical workers, and those with underlying medical conditions who are at higher risk for Covid complications.

“What [the advisory committee] has said on reflection that they are very likely to recommend that key workers come next, and then seniors and those with existing medical conditions, “Kates said.

If these three populations focused on health care workers and residents of long-term care facilities, an estimated 87 million vital workers, more than 53 million people aged 65 and over, and 100 million would be targeted with high-risk medical conditions, Kaiser finds in new research.

Availability also depends on how many doses each state is receiving, which is currently based on each state’s adult population. However, there aren’t the same proportions of audiences across all states – for example, some have more health care workers while others have more nursing home residents, Kates said.

“It’s possible that some of the initial assignments might not match,” Kates said.

According to the latest data from Johns Hopkins University, the pandemic has killed at least 299,191 people in the United States, with the number of cases over 16.25 million. These numbers account for around 19% of the 1.6 million Covid deaths worldwide and 23% of the 72.3 million cases worldwide.

CDC data shows that of approximately 262,000 Covid deaths as of December 9, more than 209,000 people were 65 years of age or older. Overall, residents of long-term care facilities have caused about 40% of deaths in the United States from Covid to date, according to the CDC.

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World News

How the US, UK and Canada Will Roll Out the Covid Vaccine

How the US, UK and Canada Will Roll Out the Covid Vaccine

With a coronavirus vaccine approved by the Food and Drug Administration on Friday, the United States became the third highly developed Western country, after the UK and Canada, to approve such a shot, and it is expected to start vaccinating people within a few days becomes.

However, the three countries have very different health systems. And they face different challenges in the race for the vaccine for millions of people.

Here are some similarities and contrasts.

First yes.

The first vaccine to be approved by American regulators and the first to be approved by their British and Canadian counterparts was developed by pharmaceutical giant Pfizer and a small company, BioNTech. It could get European Union approval within a few weeks.

A few others are close, however, notably a vaccine developed by Moderna and the National Institutes of Health, and another by AstraZeneca and the University of Oxford. It could well be that half a dozen or more vaccines will be approved in the coming months.

Throughout 2021, the shots (most vaccinations would require two injections weeks apart) can vary greatly by country, depending on the speed of regulatory approvals, government agreements to buy supplies, and the cost of the vaccines. Even within a country, there can be differences based on how easy it is to distribute and use a particular vaccine.

The Pfizer-BioNTech and Moderna-NIH vaccines are of a new type that has never been used before. They require ultra-cold storage and are more expensive than likely competitors. The Pfizer shot needs to be kept extra cold, at minus 94 degrees Fahrenheit, which most healthcare facilities aren’t equipped for.

In the UK a lot. Not in the United States. Somewhere in between in Canada.

With a strong central government and a National Health Service that covers all people, the UK, which started vaccination last week, is running the process from London. The national government selected the 50 hospitals that should receive the vaccine first and made sure they were prepared. decided how much each would get; and drafted the rules that stipulated the order in which people were entitled to receive them.

The Trump administration has shifted much of the decision-making to the states. The federal government will not need the vaccine distributed to each state based on population size, but some states have complained that they don’t know enough about the regulations.

It will be up to states to decide how the doses will be divided among hospitals, clinics, and ultimately drug stores and doctor’s offices, but first the vaccine will at least get to hospitals with ultra-cold storage.

A committee that advises the Centers for Disease Control and Prevention establishes a list of priorities, starting with medical staff. But this work is still ongoing and the guidelines are not binding. The states are expected to differ somewhat in their approach.

Canada, like Britain, has a universal health system, but like the United States, it has a federal government. The Canadian health system is decentralized and administered by the provinces and territories.

For the distribution of vaccines, the central government plans to work through these regional governments. Ottawa will play a huge role in steering the process.

That remains a bit cloudy.

Canada had ordered enough Pfizer BioNTech vaccine for all of its people, Britain enough for 30 percent, and the United States enough for 15 percent.

However, these numbers reflect shipments that are expected to take months to complete, and Pfizer, like other companies, is struggling to ramp up production. In addition, all three countries have also pre-purchased from other companies, so the pace of vaccine approval could have a significant impact on the pace of adoption.

Updated

Apr. 14, 2020 at 12:21 am ET

This speed is also influenced by the need to equip vaccination sites with proper freezers, staff to prepare the exposures, and enough syringes and protective equipment.

The first deliveries make up a small part of the pre-purchases: 800,000 cans to the UK and an estimated 249,000 to Canada this month.

US officials said they hope to have 40 million doses of the vaccine by the end of the month, which could be optimistic. That would be enough to vaccinate 20 million people.

Rural areas where hospitals are not equipped to keep vaccines at the correct temperatures or do not have the staff to prepare them for injection will not receive Pfizer images. This is more of a barrier in the US and Canada, huge countries with huge, sparsely populated regions, than it is in the UK, which is much more compact.

In Canada, where the military plays a pivotal role in vaccine distribution, the government broadcasts to all ten provinces. The three northern areas will have to wait.

In the US, FedEx and UPS will ship vaccines from distribution centers to all parts of the country. But the holiday season is the busiest time of year for delivery services, which could slow things down.

That is even darker.

The UK, Canada, the United States and the European Union have all followed similar strategies, pre-ordering large numbers of doses – more than enough to vaccinate them all – from multiple manufacturers and hedging their bets in case some of the vaccines are banned or others Manufacturers have production downtimes.

The United States has ordered far fewer doses relative to its population than Canada or the UK, and last summer they turned down an offer to increase their pre-order from Pfizer. Administration officials say the numbers are misleading because the government has signed options to buy far more vaccines if it deems it necessary.

However, given the strong global demand, it is not clear how quickly pharmaceutical companies can fill their orders, let alone additional orders.

Again, the speed of development, approval, and production affects how quickly deliveries get to people. A country that places a bigger bet on one vaccine might be a lot better off than one that is more reliant on another.

Megan Twohey and Ian Austen contributed to the coverage.

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Health

C.D.C. Panel Recommends Pfizer Vaccine for Sufferers as Younger as 16

C.D.C. Panel Recommends Pfizer Vaccine for Patients as Young as 16

An independent panel of experts advising the Centers for Disease Control and Prevention on Saturday afternoon voted to recommend the Pfizer coronavirus vaccine for people aged 16 and over. This confirmation, which only Dr. Robert Redfield, the director of the CDC, is an important signal for hospitals and doctors to continue vaccinating patients.

The confirmation follows the approval of the emergency vaccine on Friday night by the Food and Drug Administration, which oversees the licensing of medical devices.

The advisory board, which typically meets three times a year to review changes to routine vaccine schedules for children, adolescents, and adults, held numerous marathon sessions this fall to resolve a variety of gnarled questions related to the introduction of the novel vaccine to discuss, which is limited in availability during a pandemic.

In the Friday and Saturday sessions, the panel’s heated discussions focused on three main areas: whether the vaccine should be recommended for patients aged 16 and 17, for pregnant and breastfeeding women, and for patients with an anaphylactic reaction to other vaccines .

CDC officials and scientists will review the debate and provide more detailed guidance on these and other groups on Sunday and in the coming weeks as more information about the vaccine becomes available.

Shipments of nearly three million doses of the vaccine will go to the States this weekend. Most states are expected to follow CDC guidelines to reserve these doses for caregivers and residents of nursing homes and long-term care facilities.

Pregnant women were not included in clinical trials with the vaccine. The panel’s discussion on pregnancy centered on the fact that at least 330,000 health care workers in the first cohort of vaccine recipients are expected to be pregnant or breastfeeding women. While the committee urged that the decision on whether to fire the shot be left to pregnant women in consultation with their doctors, it also suggested that they object to the vaccine’s effectiveness and their personal risk of exposure to the virus the lack of data on weighing it up in relation to pregnancy.

The committee found it was not a live virus vaccine and therefore posed no risk to a nursing child.

Pfizer officials said Friday they had seen no evidence that the vaccine affects pregnancy or fertility. About two dozen women became pregnant during post-vaccination clinical trials, and the company is monitoring them.

Committee members responded to warning signs and instructions on anaphylaxis after two UK health workers had severe allergic reactions immediately after being vaccinated. Members tried to strike a balance: taking reasonable precautions without alarming a public who may already be upset about the vaccine. On Saturday, they tended to advise patients with “severe allergic reactions” like anaphylaxis to any component of the vaccine not to get the shot. They also recommended monitoring patients for 15 minutes immediately after vaccination and 30 minutes for patients with a history of anaphylaxis.

The road to a coronavirus vaccine ›

Answers to your vaccine questions

With a coronavirus vaccine spreading out of the US, here are answers to some questions you may be wondering about:

    • If I live in the US, when can I get the vaccine? While the exact order of vaccine recipients may vary from state to state, most doctors and residents of long-term care facilities will come first. If you want to understand how this decision is made, this article will help.
    • When can I get back to normal life after the vaccination? Life will only get back to normal once society as a whole receives adequate protection against the coronavirus. Once countries have approved a vaccine, they can only vaccinate a few percent of their citizens in the first few months. The unvaccinated majority remain susceptible to infection. A growing number of coronavirus vaccines show robust protection against disease. However, it is also possible that people spread the virus without knowing they are infected because they have mild symptoms or no symptoms at all. Scientists don’t yet know whether the vaccines will also block the transmission of the coronavirus. Even vaccinated people have to wear masks for the time being, avoid the crowds indoors and so on. Once enough people are vaccinated, it becomes very difficult for the coronavirus to find people at risk to become infected. Depending on how quickly we as a society achieve this goal, life could approach a normal state in autumn 2021.
    • Do I still have to wear a mask after the vaccination? Yeah, but not forever. The two vaccines that may be approved this month clearly protect people from contracting Covid-19. However, the clinical trials that produced these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected with the coronavirus can spread it without experiencing a cough or other symptoms. Researchers will study this question intensively when the vaccines are introduced. In the meantime, self-vaccinated people need to think of themselves as potential spreaders.
    • Will it hurt What are the side effects? The vaccine against Pfizer and BioNTech, like other typical vaccines, is delivered as a shot in the arm. The injection is no different from the ones you received before. Tens of thousands of people have already received the vaccines, and none of them have reported serious health problems. However, some of them have experienced short-lived symptoms, including pain and flu-like symptoms that usually last a day. It is possible that people will have to plan to take a day off or go to school after the second shot. While these experiences are not pleasant, they are a good sign: they are the result of your own immune system’s encounter with the vaccine and a strong response that ensures lasting immunity.
    • Will mRNA vaccines change my genes? No. Moderna and Pfizer vaccines use a genetic molecule to boost the immune system. This molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse with a cell, allowing the molecule to slide inside. The cell uses the mRNA to make proteins from the coronavirus that can stimulate the immune system. At any given moment, each of our cells can contain hundreds of thousands of mRNA molecules that they produce to make their own proteins. As soon as these proteins are made, our cells use special enzymes to break down the mRNA. The mRNA molecules that our cells make can only survive a few minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a little longer, so the cells can make extra viral proteins and trigger a stronger immune response. However, the mRNA can hold for a few days at most before it is destroyed.

When asked whether the vaccine should be approved for 16- and 17-year-olds, several paediatricians on the committee expressed concern that Pfizer’s data to date on the youngest participants was “thin”.

However, other committee members pushed back, saying the physiological difference between a 16-year-old and an 18-year-old was minimal. People under the age of 18 who work in long-term care facilities and “important” jobs like groceries are at high risk of contracting the virus and would likely be recommended for initial admissions, they said.

Doctors determined that these teenagers may be disproportionately colored people. By disfellowshipping them, the doctors argued, the committee would inadvertently discriminate against them based on their age.

And, as they added, because the data on side effects and efficacy are so positive, the risk of teenagers getting the virus – as well as spreading it and disrupting their schooling – outweighed the known risks of the vaccine itself.

The committee also expressed its support for making the vaccine available to people who previously tested positive for the virus. Given the limited supplies, they asked those infected within 90 days to wait until that period had expired.

The CDC is expected to issue more detailed clinical recommendations on Sunday. In addition, a comprehensive “toolkit” for providers and patients has been published that is intended to provide detailed information on how to resolve potential concerns.

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Business

CDC panel recommends Pfizer Covid vaccine for folks 16 years and older, clearing pivotal hurdle

CDC panel recommends Pfizer Covid vaccine for people 16 years and older, clearing pivotal hurdle

CDC headquarters in Atlanta

Elijah Nouvelage | Bloomberg via Getty Images

A key panel from the U.S. Centers for Disease Control and Prevention unanimously voted on Saturday to recommend Pfizer-BioNTech’s Covid-19 vaccine for people aged 16 and over. This cleared another crucial hurdle for the drug before the vaccinations begin in the coming days.

The CDC’s Advisory Committee on Immunization Practices, an external group of medical experts advising the agency, voted 11-0 in favor of recommending the vaccine for use in people aged 16 and over under the Food and Drug Administration’s emergency clearance. Three members withdrew due to conflicts.

The recommendation will now be sent to CDC Director Dr. Robert Redfield who must sign out before vaccinations can begin. A CDC spokesman was not immediately available for comment on when Redfield would sign the recommendation.

“This Covid-19 vaccine gives us hope,” said Veronica McNally, ACIP member and assistant dean of experiential education at Michigan State University College of Law. “It’s important to remember that while this vaccine was being developed at an incredible pace and incorporating new technologies, it went through all appropriate channels of regulation and the approval process was transparent.”

Dr. Beth Bell, an ACIP member and clinical professor of global health at the University of Washington, said she recognized people’s concern about this vaccine and new vaccines in general, but added that they were “safely” taking this vaccine when it is she will turn.

“I believe the process we have used here at ACIP to make this decision is transparent, science-based, fair-minded, and for this moment the absolute best we can do,” said Bell .

The vote marked the end of an hour-long meeting during which ACIP members heard presentations from CDC officials on clinical considerations for those vaccinated under the emergency license.

Dr. Sarah Mbaeyi, a CDC doctor, told the agency during a presentation that vaccines should be offered to people “regardless of a history of previous symptomatic or asymptomatic” coronavirus infection. However, Mbaeyi told the panel that a diagnostic or antibody test is not recommended to help decide whether someone should receive the vaccine.

More studies on the vaccine’s safety in pregnant women are ongoing, Mbaeyi said. However, if a pregnant woman is part of a group that is prioritized for the vaccine, Mbaeyi said she could opt for vaccination after making an informed decision with a health care provider.

The public was also asked to share comments and concerns about the vaccine and its dissemination. Claire Hannan, the executive director of the Association of Immunization Managers, told the committee that there needs to be more precise guidance on who is considered an essential worker, as definitions differ across the US.

On December 1, the group voted 13-1 for healthcare workers and residents of long-term care facilities to receive the first doses of vaccine once released for public use. The ACIP emergency meeting, postponed from Sunday to Saturday, followed the FDA’s decision to give Pfizer’s vaccine emergency approval on Friday evening.

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Business

UPS and FedEx say plans to ship the vaccine are underway.

UPS and FedEx say plans to ship the vaccine are underway.

UPS and FedEx said they would also put their own tracking tags on vaccine shipments. And Mr. Wheeler told the Senators that every UPS truck that carries the cans will have a device that tracks its location, temperature, exposure and movement. The company’s trucks will also have escorts, he said. It’s not clear if he was referring to the local police or other government officials, or possibly private guards, and the company declined to disclose.

The vaccine delivery kits were put together by McKesson, a medical supplier that has been asked by federal agencies to act as the central distributor of the vaccines and supplies such as syringes and alcohol wipes. Unlike Pfizer, Moderna, whose vaccine could soon be approved, plans to have McKesson package its vaccines alongside supplies, Smith said.

In the case of Pfizer, UPS plans to ship the kits – from a McKesson location in Kentucky – before the vaccine so that errors can be identified with addresses in its system, Wheeler said. The kits include a syringe, a substance used to dilute the vaccines, personal protective equipment, instructions and mixing vials, he said.

Shippers have spent months upgrading the cold store infrastructure for the Pfizer vaccine, which must be stored at minus 94 degrees Fahrenheit. UPS, for example, has installed ultra-low temperature freezers capable of keeping goods as low as minus 112 degrees Fahrenheit near their air freight centers in the US and Europe. Its Louisville hub also plans to produce more than 24,000 pounds of dry ice a day. FedEx has also added ultra-cold freezers to its US network.

The airlines have also prepared to ship the vaccines, working with aircraft manufacturers and the Federal Aviation Administration to safely move more dry ice than is normally allowed. UPS also sends the agency a daily file of their flights so it can prioritize others, Wheeler said. The company is in daily contact with officials involved in Operation Warp Speed, the federal effort to accelerate vaccine development.

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FDA advisory panel meets at this time to vote on whether or not to advocate approval of Pfizer’s Covid vaccine

FDA advisory panel meets today to vote on whether to recommend approval of Pfizer's Covid vaccine

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A panel from the Food and Drug Administration will meet Thursday to vote on whether to recommend Pfizer and BioNTech’s emergency approval of the coronavirus vaccine.

Prior to voting by the Agency’s Advisory Committee on Vaccines and Related Biological Products, the independent panel of medical experts will evaluate the Pfizer clinical trial data and provide their opinion on the vaccine, including whether the benefits outweigh the risks in an emergency .

The FDA is not required to follow the advice of the advisory group, but it often does.

A recommendation from the advisory committee is the final step before the FDA is likely to give final OK to the distribution of the potentially life-saving doses in the United States. The vaccine would be the first to be approved for use in the United States

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