Category: Covid-19 Vaccine

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Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine – National Institutes of Health

December 20, 2020

News Release

Friday, December 18, 2020

Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its COVID-19 vaccine, which was co-developed with scientists at the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). This innovative and monumental partnership has enabled NIH and Moderna to develop a safe and effective COVID-19 vaccine within the span of a year that will be manufactured and distributed across the U.S. The vaccine, called mRNA-1273, is a messenger RNA (mRNA) vaccine against COVID-19 encoding a prefusion stabilized form of the spike protein of SARS-CoV-2, co-developed by investigators from Moderna and NIAIDs Vaccine Research Center. The approach to stabilize the coronavirus spike protein, called S-2P, was developed by NIAID scientists and their collaborators at Scripps Research, Dartmouth College and the University of Texas at Austin. NIAID supported the early development of the mRNA-1273 vaccine, and worked with Biomedical Advanced Research and Development Authority (BARDA) scientists to support the mid- and late-stages of clinical development, with BARDA leading government support of the scale-up of manufacturing and regulatory pathway to EUA. The mRNA-1273 vaccine is the second COVID-19 vaccine in the United States to be granted an EUA. NIH Director Francis S. Collins, M.D., Ph.D., NIAID Director Anthony S. Fauci, M.D., and BARDA Director Gary Disbrow, Ph.D. released the following statements:

It has been less than a year since the world first learned of SARS-CoV-2 and the terrible disease it can cause. 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. The partnership to develop the mRNA-1273 vaccine is a prime example of the tremendous good that can be accomplished when the public and private sectors work together to address a serious public health problem. It is through the dedicated efforts of our federal scientists and their collaborators at Moderna and in academia, the clinical staff who conducted the vaccines rigorous clinical trials, and the tens of thousands of study participants who selflessly rolled up their sleeves, that another safe and highly effective vaccine to protect against COVID-19 will soon be rolled out to the American public. NIH Director Francis S. Collins, M.D., Ph.D.

Several years before SARS-CoV-2 entered the public consciousness, NIAID scientists were working with Moderna to develop vaccines for other coronaviruses. That existing scientific foundation is what enabled both partners to move quickly to develop the mRNA-1273 vaccine candidate against the novel SARS-CoV-2 coronavirus. NIAID conducted the initial Phase 1 testing of the vaccine and, with the support of BARDA and other Operation Warp Speed partners, played a central role in its large-scale clinical trial. Throughout each stage of clinical testing, the Moderna vaccine proved to be safe and highly effective at preventing symptomatic COVID-19. In a study of more than 30,000 people, it demonstrated 94%efficacy, and subsequent analyses have revealed that the vaccine induces a durable immune response. There is much we still do not know about SARS-CoV-2 and COVID-19. However, we do know that this vaccine is safe and can prevent symptomatic COVID-19 and severe disease. It is my hope that all Americans will protect themselves by getting vaccinated when the vaccine becomes available to them. That is how our country will begin to heal and move forward. NIAID Director Anthony S. Fauci, M.D.

Today stands as a reminder of what can be accomplished when people come together to reach a common goal. We are working with a constant sense of urgency to bring vaccines, therapeutics and diagnostics to bear to end the crisis. As partners in Operation Warp Speed, NIAID and BARDA scientists collaborated with Moderna, adding BARDAs expertise in late-stage clinical trials, scale-up manufacturing and regulatory requirements. By collaborating, we were able to complete these steps in parallel and accelerate the development of a safe and effective vaccine. While we celebrate todays accomplishment, we recognize that there is still much work to do to ensure every American who wants a COVID-19 vaccine receives one. Every American has been touched in some way by this virus, and so we will continue to push forward. With continued collaboration and investment in scientific research, health security, and innovative public-private partnerships, we can achieve a safer, more prepared world. BARDA Director Gary Disbrow, Ph.D.

Francis Collins, M.D., is Director of the National Institutes of Health in Bethesda, Maryland.

Anthony S. Fauci, M.D., is Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Gary Disbrow, Ph.D., is Director of the Biomedical Advanced Research and Development Authority (BARDA), in the HHS Office of the Assistant Secretary for Preparedness and Response.

Explore how we got to today: To learn more about the various milestones in the development of the NIH/Moderna vaccine and the robust portfolio of COVID-19 vaccines, visit BARDAs COVID-19 Response Timeline.

About Operation Warp Speed:OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

About HHS, ASPR, and BARDA:HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 56 FDA approvals, licensures or clearances. To learn more about BARDA COVID-19 Portfolio and BARDAs COVID-19 Response , visit http://www.medicalcountermeasures.gov/

About the National Institute of Allergy and Infectious Diseases:NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine - National Institutes of Health

N.J. to open 6 COVID-19 vaccine mega-sites. Heres the list of locations. – nj.com

December 20, 2020

New Jersey is planning to open six coronavirus vaccination mega-sites across the state early next year as it rolls out inoculations in phases, with an aim to vaccinate 70% of its adult residents within six months, state officials announced Friday.

The state is also setting up a network of more than 200 satellite vaccination sites including hospitals, health and urgent care centers, chain pharmacies, and local sites, Gov. Phil Murphy said at his latest coronavirus briefing in Trenton.

We expect the demand for the vaccine will outpace the supply, sate Health Commissioner Judith Persichilli said. So we will need to initiate vaccine sites in phases to assure equitable distribution.

The announcement comes after New Jersey hospitals began issuing the states first vaccines to healthcare workers this week. In the first four days, 2,149 of the states 650,000 healthcare workers received their first dose of the two-dose Pfizer vaccine. They will receive their second dose in about three weeks.

The state is administering vaccines in stages, with healthcare workers and longterm care residents in the 1a category people with the most potential to be exposed to the virus. They are expected to be vaccinated through January and February.

Essential workers are in the 1b category and residents over the age of 65 and those with high-risk medical conditions are 1c. The general public will come after that.

The timing of the progression among the groups depends on the supply of vaccine to our state, Persichilli said.

Officials have said vaccines may be available to the general public in April or May.

The mega-sites will serve as vaccination hubs, she said, with the hope of vaccinating 2,400 people a day at each location. The sites are expected to open in mid-January, at first to healthcare workers in the 1a category. The other categories will follow after that.

The sites will be located at:

Maritza Beniquez, an emergency room nurse at University Hospital in Newark, on Tuesday became the first person in New Jersey to get a COVID-19 vaccine.

The state will provide information about how to schedule an appointment at the sites next week, Persichilli said. There will be information for how the general public can sign up once availability increases, she addd.

As for the additional satellite sites, 215 facilities have signed up so far and more are expected to follow, Persichilli said.

As each successive group of New Jerseyans becomes eligible to be vaccinated, we will have the infrastructure in place to administer to every resident in those groups who wishes to be vaccinated, Murphy said. We will be ready, and we hope you will be, too.

Persichilli acknowledged the goal of vaccinating 70% of New Jersey adult residents about 4.7 million people in the next six months is a challenge.

Yes, that is aggressive. And yes, it is aspirational, the health commissioner said. But its what we need to do so this virus has no place to go.

Stressing that the vaccines are safe to take, Murphy said the state also needs residents to step forward and raise your sleeves.

CORONAVIRUS RESOURCES: Live map tracker | Newsletter | Homepage

Meanwhile, officials announced Friday that non-hospital healthcare workers in New Jersey can begin getting vaccines in the coming weeks at community sites across the state. Persichilli said there will be more information on that next week.

Plus, staff members and residents at nursing homes will begin vaccinations Dec. 28. a week later than other states because the state missed a federal deadline. More than 7,000 at those facilities in New Jersey have died from coronavirus complications.

In addition to the Pfizer COVID-19 vaccine, Modernas vaccine is expected to be approved by the federal government as soon as Friday evening.

But officials said New Jerseys allocation of vaccine doses have been reduced by about 20% through the end of this year, including the expected addition of Moderna doses.

The state had expected to receive more than 492,075 doses this month for both the Pfizer and Moderna vaccines, but that number has dropped to 392,800, Persichilli said.

I dont think weve got a satisfactory reason why, Murphy said. Its nothing personal. Its apparently every American state has received a smaller allocation.

Murphy has warned New Jersey residents that even though the vaccine rollout has begun, the next few weeks could be tough. New Jersey has already announced more than 1,000 deaths in December, the most in any month since June.

The vaccines mere presence in our state isnt enough to move the needle, Murphy said. We will need to embrace it and we will need to keep up with our other practices. Everything, together, is how well ultimately defeat this virus.

On Friday, the state reported another 3,976 cases and 44 additional confirmed deaths, though hospitalizations, transmission rate, and positivity rate all dropped for the first time in a long time, Murphy said.

Thank you for relying on us to provide the journalism you can trust. Please consider supporting NJ.com with a subscription.

Brent Johnson may be reached at bjohnson@njadvancemedia.com.

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N.J. to open 6 COVID-19 vaccine mega-sites. Heres the list of locations. - nj.com

What It Was Like to Participate in a Covid-19 Vaccine Trial – The New York Times

December 20, 2020

Yes, the timeline felt fast to me. I didnt know if I would get called at all. At the time when I signed up there had already been overwhelming demand to participate in the Pfizer trial. I knew the study slots were close to full.

With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:

[Track coronavirus cases and hospitalizations across the state.]

What was it like for you, a researcher, to take part in a randomized trial?

The feeling of being randomized took me by surprise. I should note that the study staff were absolutely wonderful to me. They answered all my questions and treated me with the utmost kindness, dignity and respect. But even so, randomization was unsettling. Despite knowing full well what I signed up for, it even felt unfair for a moment. As a practicing nurse, I had already had a number of potential coronavirus exposures, though fortunately, I never actually contracted the virus. It would have meant a lot to me to get the active vaccine and I really, really did not want to be in the placebo group.

A month later, you received a second injection but it was a very different experience. You had soreness at the injection site, nausea, chills, dizziness and a fever that spiked to 104.9 degrees the next day. Although you later found out that these side effects are common, do you think it will be a barrier to some people getting the vaccine? And, are the side effects you experienced anything to worry about?

I have received many vaccines in my life and have never had a strong reaction like I did with this injection, if indeed I got the active vaccine. Side effects could be a barrier if people are not prepared for them. It is critical that we as health care providers explain potential side effects patients might experience so that they come back for the second dose and do not worry that the side effects are dangerous. In almost all cases, side effects are transient and minor. My experience of having multiple side effects is very rare.

The side effects you experienced are also similar to the symptoms associated with Covid-19. How can health care providers reassure people about its safety?

First, I would urge all health care workers to get the vaccine if and when it is offered. It can go a long way with patients to say, I trust this vaccine enough to have gotten it myself. Second, I would urge health care providers to plan enough time to have a meaningful conversation with patients about their questions and concerns around these vaccines. We must be very clear that it is impossible for mRNA vaccines to cause Covid-19 and that these vaccines do not contain coronavirus. Finally, I think health care providers should be sure to explain why side effects are happening. Vaccines work by activating the bodys immune system, and it is this activation that both teaches the body how to protect itself from the virus and causes side effects like fever, chills, muscle pain, etc. Health care providers should explain that side effects are, in a way, a positive sign that the vaccine is working.

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What It Was Like to Participate in a Covid-19 Vaccine Trial - The New York Times

Framingham, Milford wonder if they’ll receive extra supplies of COVID-19 vaccine – MetroWest Daily News

December 20, 2020

In a week when the first COVID-19 vaccinations were administered in Massachusetts to front-line health care workers, there are questions over how the state plans to distribute extra doses of the vaccine to communities of color that have been battered by the pandemic.

Framingham and Milford are among those communities, as each has a sizable minority populationthat isexperiencing skyrocketing COVID-19 infection rates.

Last week, Gov. Charlie Bakers COVID-19 Vaccine Advisory Group announced plans for vaccine distribution, including an extra 20% supply to communities that suffered a disproportionate impact during the pandemic.

But there are questions about thatextra supply, including how will it be calculated and who will get it.

Sam Wong, Framinghams director of public health, has those questions.

While Wong praised the state for taking a stance on vaccine equity, he is unclear about what it will do for Framingham. The city has been classified as a"red" zone for months, the color suggesting the highest risk for COVID-19 in a spectrum developed by state public health officials.

Framingham will likely see extra doses, according Dr. Paul Biddinger, chairman of the states COVID-19 Vaccine Advisory Group, because it's one of 23 "Stop the Spread" communities. The state designated these communities to gettest sites that administer vaccines for free, because they're experiencing the highest infection rates. Marlborough is also a Stop the Spread community.

All 23 communities are "very likely" to see some level of extra vaccine, Biddinger said.

Milford, however, is not a Stop the Spread community, despite it sitting in the red zone for several weeks.

As of Tuesday, 27% of Milfords total positive COVID-19 cases to date (417 of 1,521) are classified as Hispanic/Latinx/Spanish origin. Milford Public Health Director Jacqueline Murphy cautioned that her departments data is incomplete.

Arrival of the extra doses should come duringthe second and third phases of the states vaccine distribution plan, Biddinger said.

The state is currently in Phase 1, which includes clinical and non-clinical health care workers who deal directly with COVID-19 patients;long-term care facilities;rest homes and assisted-living facilities; police, fire and emergency medical services; congregate care settings, including homeless shelters and correctional facilities; home-based health care workers; and health care workers providing indirect care to COVID-19 patients.

Phase 2 is expected to start in February. Thatgroup includes individuals with two or morecomorbidities who face ahigh risk for COVID-19 complications; early education, K-12, transit, grocery, utility, food and agriculture, sanitation, public works and public health workers; adults 65 years of age and older; and individuals with one comorbidity.

Phase 3, when vaccines are available to the general public, is expected to start in April.

Biddinger acknowledged the hardest part is how to put the extra-vaccine plan into action.

Officials will start by looking at two measurements.

One is the Social Vulnerability Index established by the U.S. Centers for Disease Control and Prevention. The index uses U.S. Census data to measure a community's social vulnerability. Data points include poverty, access to transportationand housing conditions.

The other measurement is the prevalence of COVID-19.

Biddinger explained there will be an analysis of locations that generally administer vaccines in a community, including hospitals, community health centers, medical practices, pharmacies and public-health clinics.

The state will know how many vaccinations those locations are administering and who is getting them, because federal law requires institutions to file the information. Datawill be loaded into the Massachusetts Immunization Information System, providing real-time informationthat shows which institutions in the hardest-hit communities are most effective at vaccinating residents. Those doing the best job will likely receive extra doses, Biddinger said.

Mistrustof the vaccine could curtail the states inoculation efforts, especially in communities of color.

Some in Framinghams Brazilian community arent ready to take a vaccine.

The Brazilian community is divided, said Liliane Costa, executive director at the Brazilian American Center in downtown Framingham. Some people are a little afraid of the long-term effects (of the vaccine), but I also talk to people who are ready to get vaccinated.

A recent poll of 800 residents by MassInc Polling Group in Boston bears out the feelings of mistrust in minority communities. It shows major differences in who plans to be first in line when vaccines are available.

White, college-educated respondents are near the top of the spectrum 67%said they would take a vaccine as soon as possible. The rate dropped to 48% for college-educated black respondents and 45% for Latino residents with college degrees. The lowest mark on the spectrum 38% was associated with Latinos who do not hold a college degree.

According to the poll, the top two reasons why people said they didn't trust the vaccine were that it hasnt been thoroughly tested (65%) and an overall lack of trust in the government on health care issues (61%).

There is a taint of race in the health care system, said Michael Curry,a member of the states COVID-19 Vaccine Advisory Group and incoming chief executive officer of the Mass League of Community Health Centers.He addressed the mistrust of vaccines during a virtual discussion hosted by the Boston Museum of Science entitled, Race to the Vaccine Exploring Public Confidence in a COVID Vaccination.

Curry cited historical examples of unjust treatment in the African-American community to explain its mistrust of vaccines in general, including medical experimentation on slaves; the Tuskegee Syphilis Study, which was conducted over 40 years (1932-72) without the patients informed consent; and an absence of blacks in clinical trials that results in a failureto provide data addressingillnesses in black communities.

Anti-immigration policies that hurt black and brown communities also diminish trust in the health care system, Curry noted.

To combat mistrust, Curry said there needs to be direct messaging to communities of color that speaks to the science, data and efficacy of COVID-19 vaccines.

Its all about the messaging, he said. We have to answer questions while acknowledging the past.

The Brazilian American Center is getting the message out on the benefits of COVID-19 vaccines. The nonprofit offers a range of services to Brazilian immigrants, and is using its website to educate clients about the benefits of COVID-19 vaccination. Its also using its online radio station Scalabrini Internet Radio to spread positive messages about vaccination.

Were trying everything we can, but its not easy since were not seeing people in person because of the pandemic, Costa said.

The Framingham Department of Public Health is partnering with the Edward M. Kennedy Community Health Center and physicians groups to deliver messages about the safety of COVID-19 vaccines and the importance of taking them.

Wong stressed that language barriers are not the reason for disproportionate COVID-19 suffering in minority communities.

Its more about inequities that existed before the pandemic. Wong ticked off several of them Black and Latinx residents generally have lower median household incomes, have less access to quality health care,and work in essential jobs that offer limited opportunities to work from home or remotely, which exposes them to increased risk of contracting COVID-19. Also, many Brazilian and Latinxfamilies live in multigenerational households, which can spread the virus if someone becomes infected.

All those reasons give a much higher risk for contracting disease, Wong said. Its more a pandemic of existing inequities and poverty than race or ethnicity.

The latest demographic information from Wongs department shows a wide gap between COVID-19 infectionsand deathswhen comparing white and minority communities in Framingham.

Hispanics represent 20% of the citys population, but have experienced42% of its COVID-19 cases. By comparison, non-Hispanic whites represent 60% of the citys population, but only 25% of COVID-19 cases.

The highest death rates of positive cases are among Hispanic, non-Hispanic Black/African and non-Hispanics other, all of which are more than double the death rates for non-Hispanic white and non-Hispanic Asian.

The Department of Public Health noted the disparity between whites and non-white populations would even be higher except many residents of Brazilian descent describe themselves as white.

COVID-19 has rocked Saint Mary of the Assumption Roman Catholic Church in Milford.

Weve been struggling with (COVID-19) for a long time, said the Rev.Peter Joyce, the churchs pastor.

About one-third of the churchs parishioners are from Latin-American countries, and Joyce said COVID-19 is a problem for many of them. It swept through their homes after relatives visiting from New York and New Jersey unknowingly had COVID-19.

Were all in this together, Joyce said, noting thechurch community will do whatever it takes to support those struggling in the pandemic.

Costa, of the Brazilian American Center, believes the centers older clients are ready to get the COVID-19 vaccine. But she worries about younger clients those in their 20s who are concerned about its long-term effects.

We have to work more on that. Talk more and convince them to take the vaccine, she said.

Ultimately, Costa sounded a hopeful tone.

I think in the end, everyone will get the vaccine.

Henry Schwan is the health reporter for the Daily News. Follow Henry on Twitter @henrymetrowest. He can be reached at hschwan@wickedlocal.com or 508-626-3964.

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Framingham, Milford wonder if they'll receive extra supplies of COVID-19 vaccine - MetroWest Daily News

COVID-19 vaccine tracker: What’s the progress? – DW (English)

December 20, 2020

There are more than 50 clinical trials worldwide testing potential vaccines, known as candidates, against COVID-19. So far, two of the vaccine candidates have been approved by the US Food and Drug Administration (FDA) for emergency use.

The majority of vaccine candidates for COVID-19 are still in a preclinical phase. That means the candidate vaccines are being tested in animal experiments, for example, rather than with human patients.

Please note:To be displayed as approved in the chart, a vaccine needs to be either approved by the USFDA or the European Medicines Agency(EMA), or cleared for emergency use by FDA, EMA orWHO. More details can be found here.

When those tests are deemed successful, candidate vaccines can move into clinical trial phases. That's when they are tested with humans. There are three clinical trial phases for efficacy and safety before a vaccine can be approved for use by humans. The phases differ from each other, most significantly in their scale:

Some companies, such asBioNTech-Pfizerin Europe, and Sinovac in China, have tested their vaccine candidates in several trials in parallel. For example, they have tested the same vaccine but in different age groups or with different dosages.

If clinical trials are successful, a company can formally apply to regulatory bodies to have their vaccine approved for use by the general public.

Three regulatory authorities are considered to be particularly important in this context: The FDAin the US, the Europea EMA,and the Pharmaceuticals and Medical Device Agency in Japan.

When a vaccine is approved, it doesn't mean everybody can get it immediately.

First, the vaccine has to be produced on a mass scale. With COVID-19, manufacturers aim to produce billions of doses by the end of 2021.

Second, logistics experts have to ensure appropriate distribution of the vaccine, and political leaders haveto decide who gets the vaccine first.

Read more: Can a vaccine be given out fairly?

In the end, though, it will be up to each individual to decide. A survey of more than 13,000 people in 35 countries most affected by COVID-19 showed that the majority of people asked would choose to get vaccinated.

It can take several years to develop an effective and safe vaccine. On average, it takes between 10 and 12 years, but it can take longer. The search for a vaccine against HIV has been going since the early 1980s so farwithout success.

In the case of COVID-19, researchers are racing to shorten the time it usually takes because of the ongoing pandemic. Despite the pressure that that brings, vaccine developers, manufacturers and the World Health Organization (WHO) say there will be no compromises on safety.

Research teams are aiming to accelerate, or limit, the time it takes to get to approval during the pandemic to an average duration of 16 months.

However, that will only be the beginning. Once clinical trials are successfully completedand a vaccine is approved and produced, researchers start phase IV, during which they observe the progress of vaccinated patients.

Researchers are pursuing 12different approaches for vaccines against COVID-19.

Most of the vaccine candidates use a protein-based subunit so, instead of using a complete pathogenic virus, they are built on a small component of it, such as a protein found in its outer shell.

That protein is administered to patients in a high dose, with the aim of inducing a fast and strong reaction by the human immune system.

The hope is that the immune system will "remember" the protein and trigger a similar defense reaction if or when it comes into contact with the actual virus.

Vaccines against hepatitis B and HPV (human papillomavirus), for example, are based on this principle.

Four additional approaches have made it to phase III.

Non-replicating viral vectors are a type of so-called recombinant vaccines: Researchers modify the virus' genetic information by switching on or off or altering certain functions. By doing that they can, for example, reduce the infectiousness of a virus. Such genetic modifications, however, require that science already has detailed knowledge about which parts of a virus' genetic material are responsible for which functions in order for them to be able to manipulate them effectively. The term "non-replicating" means that the virus in the vaccine enters cells in the human body but is unable to reproduce there on its own.

Inactivated vaccines use a "dead" version of the pathogen. They tend to provide a lower level of protection than live vaccines. Some vaccines in this class have to be administered several times to achieve sufficient immunity. Examples of inactivated vaccines include ones against influenza and hepatitis A.

RNA vaccines follow a different strategy, without using any "real" component of the virus at all. Instead, researchers aim to trick the human body into producing a specific virus component on its own. Since only this specific component is built, no complete virus can assemble itself. Nevertheless, the immune system learns to recognize the non-human components and trigger a defense reaction.

Vaccines based on virus-like particles use another approach: Researchers only use the empty virus envelope without any genetic material inside of it to train the immune system.

At time of writing, there were well over 100 research teams worldwidedeveloping a COVID-19 vaccine. So far, 15 teams have advanced their candidate vaccines to the third phase of clinical trials.

Five teams stand out for conducting the most extensive clinical trials:

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COVID-19 vaccine tracker: What's the progress? - DW (English)

COVID-19 Vaccine Information and FAQs for Patients – UC San Diego Health

December 20, 2020

The COVID-19 pandemic has been a challenging time, and we know that you are ready for relief. We have been working hard to keep everyone safe during the coronavirus pandemic. We are finally turning a corner with the news of a COVID-19 vaccine, one of many important tools to help us stop this pandemic.

We know you may have questions about when and how you can be vaccinated. We are currently vaccinating our health care workers. We do not yet have a timeline for beginning vaccinations for patients, and we do not have any kind of waitlist.

We will keep updating this page as we get new information.

What we currently know about COVID-19 vaccines:

What we dont know yet:

+ Expand All

Were not sure yet. But we will follow all government guidelines regarding distribution of COVID-19 vaccines. Supplies will be limited initially, and California requires that shots be made available first to those facing the greatest risk. This includes health care workers and first responders who have close, prolonged and repeated contact with patients who have COVID-19.

UC San Diego Health is committed to ensuring an equitable and orderly vaccination scheduling process in line with recommendations from the CDC and the California Department of Public Health. We will expand vaccination to the rest of the health system employees, our patients and communities beyond starting with the most at-risk and vulnerable populations in the coming months.

It will take time to get everyone vaccinated. We understand this may be concerning, especially if you or a loved one is an essential worker or at risk of serious illness. Rest assured we are working hard with state and local officials to make sure everyone in our community has access to the vaccine.

We do not have a patient vaccine waitlist at this time. When vaccines are available for our patients, we will provide more information. Thank you for your patience and understanding.

No. UC San Diego Health is not currently offering the COVID-19 vaccine to the public, and we do not have a waiting list for the vaccine.

As soon as we receive guidance on when and how vaccines will be distributed to the public, we will share that information. We will continue to update this page with the latest information on vaccine distribution.

There are many benefits to getting vaccinated. A COVID-19 shot is your best chance to avoid becoming infected with the virus or possibly to avoid getting seriously ill even if you do get infected. It can also help prevent you from spreading the virus to others around you, including your loved ones and perhaps those more vulnerable or who haven't yet been or cannot be vaccinated.

No vaccine is 100 percent effective. So the more people in our communities who become vaccinated, the less the virus will circulate among us and the better protected we all will be.

So far, more than 295,000 people have died in the United States from COVID-19. Many of them were young and did not have underlying medical conditions. Many people who survived COVID-19 have debilitating breathing, cardiac, kidney and neurological problems, even months after recovering from the immediate infection.

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to COVID-19 vaccines from Pfizer and Moderna. The first shipment of vaccine we received was the Pfizer vaccine, and we also expect to receive some Moderna vaccine when it is available.

Dozens of companies around the world are working on developing and testing vaccines. That includes AstraZeneca and Janssen, which are engaged in Phase III clinical trials for COVID-19 vaccines. (UC San Diego Health has been a testing partner for three of the four leading vaccines in Phase III clinical trials: Moderna, AstraZeneca and Janssen.)

The Pfizer, Moderna and AstraZeneca vaccines all require two injections, roughly 21 to 28 days apart. The Janssen vaccine involves a single shot.

The estimated full effectiveness rate for the Pfizer and Moderna vaccines after two shots is 95 percent, based on clinical trial data.

It is not known how the efficacy of the vaccine changes with longer intervals between injections. However, if there is a delay of a couple of weeks between doses, experts think the added time poses no safety or effectiveness issues.

Yes. We will continue wearing masks to keep ourselves and everyone safe, including many who haven't yet been or cannot be vaccinated. In addition, we should continue to follow social distancing, hand hygiene guidelines and all other recommendations and requirements from public health agencies.

Wearing a mask is mandatory at all UC San Diego facilities, from parking lots to testing tents to clinics.

We encourage you to get your flu shot to help prevent unnecessary hospitalizations during the pandemic.

Some people may experience side effects, such as injection site reactions, fatigue, headaches, muscle pain, joint pain and fever. These transient side effects, however unpleasant, should not be alarming. They are a good sign that your bodys immune response system is building future protection.

Please remember:

None of these side effects is unique to the COVID-19 vaccine.

Pfizer says there is a "remote chance"that its vaccine could cause a severe allergic reaction, which would usually occur within a few minutes to one hour after getting a dose of the vaccine. If you have a history of allergic reactions, please inform your vaccination provider before inoculation.

No, none of the current leading vaccines (Pfizer, Moderna, AstraZeneca and Janssen) contain the whole SARS-CoV-2 virus. They cannot give you COVID-19. Get more information from the CDC.

Different vaccines use different methodologies, both well-tested and new. By making antibodies, the vaccines increase our bodys immune response to SARS-CoV-2, the novel coronavirus that causes COVID-19. Then, if we are exposed to the virus in the future, our bodies are already prepared to fight the virus and help prevent us from getting sick.

When enough people in the community have protection to fight off a virus called herd immunity it is unable to spread quickly and cause disease. Based on current knowledge, its estimated that herd immunity to COVID-19 would mean 60 to 70 percent of the population to have antibodies to the disease, either through vaccination or previous infection.

No. Data from the Pfizer and Moderna clinical trials show that protection from COVID-19 appears to begin approximately two weeks after the first injection. But it is strongly recommended that everyone complete the two-dose regimen to fully boost immunity and stronger, longer-lasting protection.

That remains to be seen. The novel coronavirus SARS-CoV-2, which causes COVID-19, emerged only late 2019. While much has been learned since then and development of vaccines has occurred with unprecedented speed there is much about the virus that remains a mystery, including how long vaccine protection lasts and how frequently SARS-CoV-2 mutates, necessitating vaccine adaptation. Influenza mutates routinely and often, requiring annual, reformulated vaccines. At this point, the novel coronavirus does not appear to mimic that behavior. Research is ongoing.

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COVID-19 Vaccine Information and FAQs for Patients - UC San Diego Health

How long will the COVID-19 vaccine protect you? – Chron

December 20, 2020

With COVID-19 vaccine being distributed to 21 Houston-area hospitals this week, medical professionals who have battled COVID-19 on the frontlines for nearly a year are finally receiving inoculations.

Houston's Memorial Hermann Infectious Disease Specialist Dr. Linda Yancey was one of the first local healthcare providers to receive the vaccine. Chron spoke to Dr. Yancey about her experience and what to expect from the new vaccine.

Yancey: My arm is sore, but other than that, I've experienced no fever or headaches. Just a sore arm. When I drove back from the hospital, it kind of hit me. I hadn't contracted COVID-19 yet. I had spent these past nine months watching my friends and colleagues get sick one by one. A few colleagues had to be hospitalized and one of them died. Every time I had a cough or a sneeze, 'I would think--is this it? Have I got it?' Then, it hit me that I didn't have to worry about that anymore.

VACCINES IN TEXAS: COVID-19 expert: "Take the first FDA-approved vaccine offered"

No, not at all. I realize that this is a new vaccine, and folks are a little wary. I'm very comfortable with the safety and the effectiveness of this vaccine. I'm expecting with the second one, with the booster, I may have side effects. But again, these would be relatively mild.

It's been a long, hard slog not knowing when the end was in sight. Every time we had another surge, we had more patients, more in the ICU. But now we have a new vaccine. Now there's a light at the end of the tunnel. The tunnel will still be long. This will be a long, hard winter for us. It will take time to get everyone vaccinated.

What I can tell you is that the first people to get the new vaccine back in March in the initial safety trial are still protected. So, a minimum of nine months, fingers crossed, three to four years. That would consistent with the animal data we have on other coronavirus vaccines. I realize that three to four years doesn't sound very long, but in the middle of the pandemic, it feels like an eternity.

It's safe, it's effective. One of the reasons why I wanted to be one of the first to get this, is that I wanted to lead by example. To show my nurses, colleagues that I'm not asking them to do anything that I wouldn't do myself. This is a scarce resource. It is ok if you have concerns to wait a month. I would rather people have confidence in this vaccine.

I just can't wait. I have four kids and a husband. I want them protected as soon as possible with this new vaccine. I want my parents protected. If I could give everyone in the country a dose of this vaccine today, I would.

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How long will the COVID-19 vaccine protect you? - Chron

COVID-19 vaccine is flying high and on dry ice to reach you – CNET

December 20, 2020

FedEx will use Boeing 767 aircraft, like the one pictured here, to deliver COVID-19 vaccines.

Air cargo is vital to our lives. Planes swiftly deliver our food and mail, goods we buy online (like the laptop I'm writing this on) and flowers we order for Mother's Day. Approximately 35% of world trade travels in airplanes, according to the International Air Transport Association, accounting for $6 trillion worth of goods.

It's also critical to public health. Air cargo carriers will be at the forefront of distributing the Pfizer and Moderna COVID-19 vaccines around the planet. Transporting vaccines by air isn't new -- that's how flu vaccines get distributed every year -- but the significance and scope of the COVID-19 vaccine distribution is unmatched. Pfizer alone expects to produce up to 50 million vaccine doses in 2020 and 1.3 billion in 2021, and they'll all need to get somewhere.

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Familiar giants like UPS, DHL and FedEx will play a big role in the process, but so will passenger airlines with cargo operations, like American, United and Delta. Here's what they're doing to prepare to keep the vaccines safe and carry them to you.

Just keep in mind that even though vaccines are now being administered, the coronavirus pandemic is raging on, with almost 74 million cases and 1.65 million deaths around the world to date. Social distancing and mask wearing are still absolutely essential for fighting the spread of the virus and protecting the health of you and others. And they'll remain that way for many months, even after you're vaccinated.

Pfizer's vaccine, just approved for use by the FDA on Friday, needs to be stored at a temperature of minus 94 degrees Fahrenheit (minus 70 degrees Celsius). Cargo that must be kept extremely cold typically can be transported in "active" containers with built-in temperature controls (like a portable freezer) or "passive" containers that are cooled with dry ice. Either way, all containers used to ship the vaccines will have temperature recorders to ensure vaccine safety.

The advantage of passive containers is that they're lighter, making them more portable, and they don't require a power source. Intending to distribute its vaccine as fast as possible, Pfizer went with the passive option by designing its own containers (according to The Wall Street Journal, the containers are the size of a suitcase).

Airlines have more options for vaccines that don't need to be kept as cold, likeModerna's(which still needs FDA approval). United Airlines, for example, says that with 15 different cargo container options, "we can support a variety of temperature needs whether ambient, cool or frozen."

Delta employees offload vaccines from an aircraft.

UPS says it will monitor all shipments from a new dedicated command center. The facility will be staffed around the clock and will collect data from the temperature recorders in shipping containers. Each UPS package also will have a tag identifying it as a vaccine shipment. The company built its own dry ice manufacturing facility at its hub in Louisville, Kentucky, with a capacity of more than 24,000 pounds each day.

Other carriers will monitor shipments as well. American Airlines will do so from its Cargo Control Center at its headquarters in Fort Worth, Texas, and Delta Airlines will have a "Vaccine Control Tower" with centralized monitoring and customer reporting.

Cargo containers are loaded into a United Airlines Boeing 777 at San Francisco International Airport in 2018.

It depends on the carrier and the available aircraft it has in its fleet. But generally a bigger plane is better, since it can fit more shipments. United Airlines says one of its Boeing 777-200s, one of the largest aircraft in its fleet, has the ability to carry more than a million doses of vaccine. American also operates the 777, while Delta's largest airliner is the comparatively sizedAirbus A350.

With largely wide-body fleets includingBoeing's 777, 767 and 747; the Airbus A300; and the McDonnell Douglas MD-11, FedEx and UPS will be able to move large quantities of doses as well.

Now playing: Watch this: How United Airlines prepares a Boeing 777 between flights

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Yes. Though it depends on the route flown, United and American will use both all-cargo and passenger flights. The vaccines will be stored below the passenger cabin in the cargo hold.

A FedEx employee handles dry ice for a shipment.

Dry ice is solid carbon dioxide, the same molecule humans and animals breathe out. As long as it's handled properly, it'll keep everything from food to medicines cold for long periods without posing much of a health risk (that is, unless you touch it with bare hands).

The bigger danger is if dry ice warms above minus 78.5 degrees Celsius ( minus 109.3 degrees Fahrenheit). At that point it will sublimate, meaning it turns directly to an odorless and colorless gas, skipping the liquid state. Carbon dioxide is harmful when we breathe it in. A small amount can cause a loss of cognitive function, fatigue or unconsciousness (not ideal conditions for a pilot), and too much can lead to a coma or even asphyxiation.

Because those dangers are compounded in an enclosed space like an airplane, the Federal Aviation Administration on Dec. 10 issued a Safety Alert for Operators advising carriers to do the following (among other things):

American monitors flights from its operations control center in Fort Worth, Texas.

Given that the FAA manages the nation's air traffic control system, it'll have a big role. In an email to CNET, an agency spokeswoman said this:

"The FAA will handle flights carrying COVID-19 vaccines the same way we handled flights carrying personal protective equipment in the spring of 2020. Airlines will provide lists of flights carrying COVID-19 vaccines to the FAA's Command Center, which will alert air traffic facilities in the field that these are priority flights. The Command Center will closely track the flights along their routes to ensure they are given priority to the degree possible."

The FAA also issued an advisory for airports handling vaccine flights, with points like giving priority access to ground vehicles collecting the vaccine, and it relaxed rules on how much dry ice airlines can carry on their flights. (Even passengers can carry a small amount in checked baggage.) United said it can now carry 15,000 pounds of dry ice per flight -- five times more than normally permitted, and FedEx will be able to transport approximately 500,000 dry ice shipments a month.

Vaccines ready for shipment at a UPS facility.

Once a vaccine shipment arrives at an outbound shipping facility, airlines will need to keep it cold. This temperature-controlled cargo infrastructure already exists, though some companies will be expanding their network to meet demand.

FedEx says it's added more than 10 secure cold storage facilities over the past three years and now has more than 90 in North and South Americas, Asia, Australia and Europe. The company also added ultracold freezers, and expanded freezer and refrigerator capacity at some locations.

UPS has invested in a "freezer farm" in Louisville for ultracold storage and will supply portable freezers for vaccine dosing sites where dry ice isn't available.

American will use its existing temperature-controlled facilities at airports in Philadelphia, Miami, Dallas, London, Chicago and San Juan, Puerto Rico. Delta will rely on cold storage at airports in Atlanta, Detroit, Los Angeles, New York and Seattle.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

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COVID-19 vaccine is flying high and on dry ice to reach you - CNET

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