Tag: Dose

Categories
Health

I’m Not Eligible for the Vaccine But. Can I Hunt for a Surplus Dose?

I’m Not Eligible for the Vaccine Yet. Can I Hunt for a Surplus Dose?

I am a college student and I recently learned that my city will open places on the Ministry of Health website to anyone who can be vaccinated if there is an excess of vaccines. We’re still in the first stage of vaccination, but if I check the vaccination website a lot, I could theoretically get an appointment.

Since I am a healthy young person, not an essential worker or at risk, should I wait to be vaccinated in hopes that someone at higher risk or greater risk could take the place? Or should I keep checking this website and taking the dose as soon as it appears? I’m not taking someone else’s place, am I? Ben, Montana

With something perishable – whether it is a lettuce or a thawed carton of Covid-19 vaccines – you can have excess and spoilage with a general deficiency. The minimum order quantity for Pfizer vaccines is one tray of approximately 1,200 doses. Once the vials begin to thaw, they will need to be used in five days. For all approved vaccines, a vial that has been opened once must be used within six hours – Johnson & Johnson uses two hours at room temperature. Each Pfizer vial contains up to six doses. Johnson & Johnson, which has a minimum order of 100 doses, puts five doses in one vial; Moderna will shortly be dispensing 14 doses in each vial.

The point is, vaccines don’t come as “loosies”. Vaccination centers can misjudge the number of registrations, and even when everything is planned correctly, there are sometimes no-shows. Even if a site has a standby list of qualified recipients, there are occasions when a vaccine is wasted unless the eligibility rules are suspended.

Perhaps the question is not whether you would take someone else’s place, but whose place you would take. I think of the verse that we apparently owe to the 19th century English lawyer and joke of Charles Bowen:

The rain, it rains on the righteous
And the unjust guy too.
But mainly to the righteous because
The unrighteous steal the umbrella of the righteous.

In a situation where expired vaccine doses are being offered to all comers – so they don’t just go to waste – you have no reason to believe that the dose you are avoiding will go to someone in greater need. When those concerned with justice demure, the dose can simply go to those who are not so concerned, provided it goes to anyone. There will always be a tradeoff between vaccinating the country quickly and exquisitely fine-tuning the rollout to reflect each person’s risk profile. If a sporadic all-comer approach is the best way to avoid wasted doses, then it’s not unfair and you are not wrong to be part of it.

There will always be a tradeoff between vaccinating the country quickly and exquisitely fine-tuning the rollout to reflect each person’s risk profile.

Updated

March 18, 2021, 8:24 p.m. ET

There is one other thing to note. Although your age is very unlikely to get seriously ill with Covid-19, you can still spread it. In fact, it is not uncommon for people who never show serious symptoms of the disease to transmit the virus. The evidence available suggests that post-vaccination transmission is less likely, perhaps much less likely. Like wearing a mask, your vaccination will help protect you and others. It’s much better for a dose to go in your arm than in the trash.

I live in a state where vaccinations are a priority for people over 65 and people over 16 with chronic illnesses. As elsewhere, the rollout was far from smooth: it was reported that the county received over 30,000 simultaneous phone calls last weekend when it announced that 9,000 appointments were available. No “evidence of chronic condition” is required and our state has made it clear that it relies on the honor system for vaccination seekers.

I am 44 years old and reasonably healthy. I have been overweight since I was a child. At times in my adult life I have been much heavier than I am now, which is exactly the line between “overweight” and “obesity” (classified as a BMI of 30 or higher; I am about 29 years old now). My state regards anyone classified as “obese” as a priority group for vaccination. Is it ethically correct for me to change the definition of the term “chronic condition” and theoretically be one step ahead of someone else who may be in a much higher risk category? Name withheld

You ask if You can lie to get vaccinated faster. My answer is no. But there is an interesting question that you did not ask. Would it be okay to have an eating binge to bring your BMI to 30? In this scenario, you would not be able to assert yourself when requesting an appointment. Surely you would still abuse the system. Any criterion that can be hacked in this way is problematic precisely for this reason. Of course, the BMI thresholds used by states (30 in some cases, 40 in others) are inherently arbitrary: a study in the Proceedings of the National Academy of Sciences last fall found the rate of hospital admissions for Covid-19 increased with our BMI increases linearly, starting with those who are only slightly overweight. This suggests that maintaining yourself at a healthy weight may be a better option than increasing it.

I’ve worked at farmers markets in New York City for many years, but since the pandemic, I’ve moved to full-time communication work at a church (including producing their new livestream) and only invested a day a week in the market. As a market worker, I am now eligible for the Covid vaccine. I want to get vaccinated as soon as possible, for my own safety and for the good of all, but the truth is, my job and lifestyle allow me to stay fairly isolated and protected from infection. Aside from my obvious advantages – or rather the privileges – of being highly computer literate, fluent in English, and having the time to navigate the Byzantine vaccination system, I feel like my exposure is limited than a day-a-week -Worker is essential My entitlement to vaccination is in doubt. I want this vaccine to be introduced ethically, and ideally, privilege doesn’t matter. But is eligibility pure and simple? Damon, New York

What is important is try to remove barriers to vaccination – including those created by lack of access to transport, the internet, or English. Recruiting churches and other community organizations can help reach the city’s underserved and sometimes vaccine reluctant population. Indeed, your work with the Church could enable you to help here. However, once a reasonable system is in place, the authorization is actually the authorization. They don’t suggest using internal connections to skip the line. You will have the advantage of your skills and abilities, but you will likely not qualify for the FEMA zip code restricted vaccination centers, which are specifically targeted at the city’s vulnerable communities. All of this means that your laudable concern for justice does not mean that you should refuse the umbrella that is offered.

Categories
Health

Research Counsel Folks Who Had Covid-19 Ought to Get Single Vaccine Dose

People Who Have Had Covid Should Get Single Vaccine Dose, Studies Suggest

Almost 30 million people in the United States – and likely many others whose diseases have never been diagnosed – have been infected with the coronavirus to date. Should these people still be vaccinated?

Two new studies answer this question with an emphatic yes.

In fact, research suggests that for these people, just one dose of the vaccine is enough to charge their antibodies and destroy the coronavirus – and even some other infectious variants.

The results of these new studies are consistent with the results of two others published in the past few weeks. Taken together, the research suggests that people who have had Covid-19 should be immunized – but a single dose of the vaccine may be enough.

“I think it’s a really strong rationale for why people who were previously infected with Covid should get the vaccine,” said Jennifer Gommerman, an immunologist at the University of Toronto who was not involved in the new research.

A person’s immune response to a natural infection varies widely. Most people make plenty of antibodies that last for many months. However, some people who have had mild or no symptoms of Covid-19 produce few antibodies that quickly drop to undetectable levels.

The vaccines “even hit the pitch,” said Dr. Gommerman, so that anyone who has recovered from Covid-19 will make enough antibodies to protect against the virus.

The latest study, which has not yet been published in a scientific journal, analyzed blood samples from people with Covid-19. The results suggest that her immune system would have problems fighting off B.1.351, the coronavirus variant first identified in South Africa.

But a shot of the Pfizer BioNTech or Moderna vaccine changed the picture dramatically: It increased the amount of antibodies in her blood by a thousand times – “a massive, massive surge,” said Andrew T. McGuire, immunologist at Fred Hutchinson Cancer Research Center in Seattle, who led the study.

Rinsed with antibodies, samples from all participants were able to neutralize not only B.1.351, but also the coronavirus that caused the SARS epidemic in 2003.

In fact, the antibodies appeared to work better than those in people who did not have Covid and had received two doses of a vaccine. Several studies have shown that the Pfizer-BioNTech and Moderna vaccines are about five times less effective against the variant.

The researchers received blood samples from 10 volunteers in the Seattle Covid Cohort Study who were vaccinated months after contracting the coronavirus. Seven of the participants received the Pfizer BioNTech vaccine and three received the Moderna vaccine.

Blood taken about two to three weeks after vaccination showed a significant increase in antibody levels compared to the samples taken before vaccination. The researchers don’t yet know how long the increased levels of antibodies will last, but “hopefully they will last,” said Dr. McGuire.

The researchers also saw a surge in immune cells remembering and fighting the virus, said Dr. McGuire. “It looks pretty clear that we are boosting their pre-existing immunity,” he said.

In another new study, New York University researchers found that a second dose of the vaccine was of no great benefit at all for people with Covid-19 – a phenomenon that has also been seen with vaccines against other viruses.

In this study, most people had been infected with the coronavirus eight or nine months previously, but their antibodies increased hundreds to a thousand times with the first dose of a vaccine. However, after the second dose, the antibody levels did not rise any further.

“It is real evidence of the strength of immunological memory that they are given a single dose and have a huge increase,” said Dr. Mark J. Mulligan, director of the NYU Langone Vaccine Center and lead author of the study.

In some parts of the world, including the United States, a significant minority of the population is already infected, noted Dr. Mulligan firmly. “You should definitely be vaccinated,” he said.

It is unclear whether the thousand-fold increase in antibody levels recorded in the laboratory will occur in real-world environments. However, research shows that a single shot is enough to significantly raise antibody levels, said Florian Krammer, an immunologist at the Icahn School of Medicine on Mount Sinai in New York.

Dr. Krammer led another of the new studies that showed that people who had Covid-19 and received a dose of vaccine had more serious side effects from the vaccination and had more antibodies than those who had not been infected before.

“When you put all four papers together, you get pretty good information about people who have had an infection and only need one vaccination,” said Dr. Krammer.

He and other researchers are trying to convince scientists from the Centers for Disease Control and Prevention to recommend only one dose for those who have recovered from Covid-19.

Ideally, these people should be monitored after the first shot in case their antibody levels drop after a few weeks or months, said Dennis R. Burton, an immunologist at the Scripps Research Institute in La Jolla, California.

The fact that the charged antibodies seen in the new study can fight the 2003 SARS virus suggests that a single dose of the vaccine may have induced the volunteer’s bodies to produce “largely neutralizing antibodies” – immune molecules that are able to target a wide range of related antibodies to viruses, said Dr. Burton.

He and other scientists have spent decades investigating whether largely neutralizing antibodies can fight multiple versions of HIV at the same time. HIV mutates faster than any other virus and evades most antibodies quickly.

The new coronavirus is mutating much more slowly, but there are now several variants of the virus that appear to have become more contagious or which are thwarting the immune system. The new study could provide clues on how to make a single vaccine that stimulates the production of largely neutralizing antibodies that can destroy all variants of the coronavirus, said Dr. Burton.

Without such a vaccine, scientists would have to adjust the vaccines every time the virus changes significantly. “You’re kind of a whac-a-mole approach,” he said. It will likely take many months, if not more, to develop and test this type of vaccine against the coronavirus, but “this is the longer term way to approach this virus.”

Categories
Health

Folks Who Have Had Covid Ought to Get Single Vaccine Dose, Research Recommend

People Who Have Had Covid Should Get Single Vaccine Dose, Studies Suggest

Almost 30 million people in the United States – and likely many others whose diseases have never been diagnosed – have been infected with the coronavirus to date. Should these people still be vaccinated?

Two new studies answer this question with an emphatic yes.

In fact, research suggests that for these people, just one dose of the vaccine is enough to charge their antibodies and destroy the coronavirus – and even some other infectious variants.

The results of these new studies are consistent with the results of two others published in the past few weeks. Taken together, the research suggests that people who have had Covid-19 should be immunized – but a single dose of the vaccine may be enough.

“I think it’s a really strong rationale for why people who were previously infected with Covid should get the vaccine,” said Jennifer Gommerman, an immunologist at the University of Toronto who was not involved in the new research.

A person’s immune response to a natural infection varies widely. Most people make plenty of antibodies that last for many months. However, some people who have had mild or no symptoms of Covid-19 produce few antibodies that quickly drop to undetectable levels.

The vaccines “even hit the pitch,” said Dr. Gommerman, so that anyone who has recovered from Covid-19 will make enough antibodies to protect against the virus.

The latest study, which has not yet been published in a scientific journal, analyzed blood samples from people with Covid-19. The results suggest that her immune system would have problems fighting off B.1.351, the coronavirus variant first identified in South Africa.

But a shot of the Pfizer BioNTech or Moderna vaccine changed the picture dramatically: It increased the amount of antibodies in her blood by a thousand times – “a massive, massive surge,” said Andrew T. McGuire, immunologist at Fred Hutchinson Cancer Research Center in Seattle, who led the study.

Rinsed with antibodies, samples from all participants were able to neutralize not only B.1.351, but also the coronavirus that caused the SARS epidemic in 2003.

In fact, the antibodies appeared to work better than those in people who did not have Covid and had received two doses of a vaccine. Several studies have shown that the Pfizer-BioNTech and Moderna vaccines are about five times less effective against the variant.

The researchers received blood samples from 10 volunteers in the Seattle Covid Cohort Study who were vaccinated months after contracting the coronavirus. Seven of the participants received the Pfizer BioNTech vaccine and three received the Moderna vaccine.

Blood taken about two to three weeks after vaccination showed a significant increase in antibody levels compared to the samples taken before vaccination. The researchers don’t yet know how long the increased levels of antibodies will last, but “hopefully they will last,” said Dr. McGuire.

Updated

Apr. 19, 2021 at 12:01 am ET

The researchers also saw a surge in immune cells remembering and fighting the virus, said Dr. McGuire. “It looks pretty clear that we are boosting their pre-existing immunity,” he said.

In another new study, New York University researchers found that a second dose of the vaccine was of no great benefit at all for people with Covid-19 – a phenomenon that has also been seen with vaccines against other viruses.

In this study, most people had been infected with the coronavirus eight or nine months previously, but their antibodies increased hundreds to a thousand times with the first dose of a vaccine. However, after the second dose, the antibody levels did not rise any further.

“It is real evidence of the strength of immunological memory that they are given a single dose and have a huge increase,” said Dr. Mark J. Mulligan, director of the NYU Langone Vaccine Center and lead author of the study.

In some parts of the world, including the United States, a significant minority of the population is already infected, noted Dr. Mulligan firmly. “You should definitely be vaccinated,” he said.

It is unclear whether the thousand-fold increase in antibody levels recorded in the laboratory will occur in real-world environments. However, research shows that a single shot is enough to significantly raise antibody levels, said Florian Krammer, an immunologist at the Icahn School of Medicine on Mount Sinai in New York.

Dr. Krammer led another of the new studies that showed that people who had Covid-19 and received a dose of vaccine had more serious side effects from the vaccination and had more antibodies than those who had not been infected before.

“When you put all four papers together, you get pretty good information about people who have had an infection and only need one vaccination,” said Dr. Krammer.

He and other researchers are trying to convince scientists from the Centers for Disease Control and Prevention to recommend only one dose for those who have recovered from Covid-19.

Ideally, these people should be monitored after the first shot in case their antibody levels drop after a few weeks or months, said Dennis R. Burton, an immunologist at the Scripps Research Institute in La Jolla, California.

The fact that the charged antibodies seen in the new study can fight the 2003 SARS virus suggests that a single dose of the vaccine may have induced the volunteer’s bodies to produce “largely neutralizing antibodies” – immune molecules that are able to target a wide range of related antibodies to viruses, said Dr. Burton.

He and other scientists have spent decades investigating whether largely neutralizing antibodies can fight multiple versions of HIV at the same time. HIV mutates faster than any other virus and evades most antibodies quickly.

The new coronavirus is mutating much more slowly, but there are now several variants of the virus that appear to have become more contagious or which are thwarting the immune system. The new study could provide clues on how to make a single vaccine that stimulates the production of largely neutralizing antibodies that can destroy all variants of the coronavirus, said Dr. Burton.

Without such a vaccine, scientists would have to adjust the vaccines every time the virus changes significantly. “You’re kind of a whac-a-mole approach,” he said. It will likely take many months, if not more, to develop and test this type of vaccine against the coronavirus, but “this is the longer term way to approach this virus.”

Categories
Health

The second dose of Covid vaccine is required for full immunity, infectious illness specialist says

The second dose of Covid vaccine is needed for complete immunity, infectious disease specialist says

According to Dr. Paul Offit, director of the Vaccine Education Center at Philadelphia Children’s Hospital, the second dose of the Covid-19 vaccine is critical to creating longer and complete immunity as well as preventing variants of the virus.

“We need to know that this is a two-dose vaccine,” Offit told CNBC’s The News with Shepard Smith. “The second dose of the Pfizer or Modern vaccine increases it dramatically, inducing the type of cells that suggest you have longer long-term memory, which means the vaccine would last a few years. I think when we have humans Getting only one dose of the vaccine that gives you shorter and less complete immunity will only lead to variants. “

His comments came after a recent study suggested that the second shot of the Pfizer vaccine could be delayed as the first offered high protection, according to a letter published in the New England Journal of Medicine.

To date, more than 15 million people in the US have received both shots of a two-dose Covid vaccine, according to the Centers for Disease Control and Prevention. Almost 25 million additional people in the country have received their first vaccination shot.

Moderna said last month that it plans to test a booster shot of its Covid vaccine a year after the first two-dose immunization.

“If you get a booster shot of this virus, which is the most common virus in circulation and produces more cross-reactive antibodies … you don’t necessarily have to load up with another vaccine when a variant reaches the point of being completely resistant to immunity, then we have to develop the second generation vaccine, “said Offit. “Right now it could mean a booster shot of the vaccines we’ve already made.”

Subscribe to CNBC PRO for exclusive insights and analysis as well as live business day programs from around the world.

Categories
Health

CDC to analyze demise of Nebraska man who acquired Covid vaccine dose

CDC to investigate death of Nebraska man who received Covid vaccine dose

Vials and a medical syringe are displayed in front of the Food and Drug Administration (FDA) US logo. The FDA finds the COVID-19 vaccine.

Pavlo Gonchar | LightRocket | Getty Images

The Centers for Disease Control and Prevention will investigate the death of a Nebraska man after local health officials listed the Covid-19 vaccine as one of several causes of death, the Nebraska Department of Health and Human Services said in a press release on late Thursday with.

The man, a long-term care facility in his late forties with multiple concurrent diseases and conditions, died on January 17 between one and two weeks after receiving his first dose of a Covid-19 vaccine.

The CDC and FDA received 1,170 reports of deaths in people in the United States who received Covid vaccine between December 14 and February 7 – 0.003% of those vaccinated. During that time, over 41 million doses of Pfizer or Moderna’s Covid were administered 19 vaccines across the country, according to the CDC.

“Typically, deaths from COVID-19 vaccines can be attributed to anaphylaxis and occur relatively soon after the vaccine is administered, so monitoring is done,” said Dr. Gary Anthone, Nebraska Chief Medical Officer.

“While I can’t speculate about this case, if people die days or weeks after being given the vaccine, it is more likely to be due to other underlying factors,” Anthone said.

The death was recorded on the Vaccine Adverse Event Reporting System, a national vaccination safety monitoring program run by the CDC and the Food and Drug Administration. All adverse events or deaths must be reported to the system if they occur after vaccination.

“This process enables the CDC and FDA to closely monitor and assess adverse events for ongoing safety assessments,” said a statement from the state health department.

The CDC has not reported any patterns for cause of death that would suggest safety issues with the vaccines.

People with high-risk diseases should consult their medical providers about vaccination, Anthone said.

Categories
Business

Delaying second AstraZeneca vaccine dose does work, examine exhibits

Delaying second AstraZeneca vaccine dose does work, study shows

A health worker shows a vial of the Covid-19 coronavirus vaccine from AstraZeneca-Oxford at Patan Hospital near Kathmandu on January 27, 2021.

PRAKASH MATHEMA | AFP | Getty Images

The UK’s decision to postpone AstraZeneca University Oxford’s second shot of coronavirus vaccine has proven to be an effective strategy, according to results from a new study.

Oxford University researchers found that the Covid-19 vaccine was 76% effective at preventing symptomatic infection for three months after a single dose, and that the rate of effectiveness increased with a longer interval before the first and second dose.

“The effectiveness of the vaccine after a single standard dose of the vaccine from the 22nd to the 90th day post-vaccination was 76% … and the modeled analysis showed that protection did not diminish during this initial 3-month period,” said the Study that was reviewed by The Lancet Medical Journal and published as a preprint on Tuesday found.

The effectiveness rate increased to 82.4% when at least 12 weeks were before the second dose. When the second dose was given less than six weeks after the first, the rate of effectiveness was 54.9%.

“These analyzes show that greater vaccine effectiveness is achieved with a longer interval between the first and second dose and that a single dose of vaccine is highly effective in the first 90 days, which further supports current policy,” the report said .

The UK’s current strategy is to vaccinate as many people as possible with a single dose first and postpone the second dose for up to 12 weeks. The idea is that a first dose will provide at least some of the protection and allow more people to have access to the vaccines while their availability is limited.

The decision to delay the administration of a second booster dose has sparked controversy, with some questioning whether it might reduce the effectiveness of the vaccine in preventing severe Covid-19 infection.

However, the UK Joint Committee on Vaccination and Immunization supported the approach. The UK is also delaying the second dose of Pfizer BioNTech vaccine, a move vaccine makers have warned about, arguing that there is no data to support a delay.

The study also provided key data on whether the vaccine reduced transmission of the virus, a previously unknown and crucial question for policy makers looking to lift measures to lock down the economy.

Based on weekly swabs from volunteers in the UK study, a 67% reduction in transmission was found after the first dose of the vaccine.

Effective strategy

This latest study supports the UK Government’s decision and concludes that vaccination programs “aiming to vaccinate a large proportion of the population with a single dose, with a second dose given after a period of three months, are an effective strategy to reduce disease and may be the optimum for pandemic vaccine introduction when supply is limited in the short term. “

The study used additional data from ongoing clinical trials of the vaccine. A separate announcement from AstraZeneca on Wednesday showed that the vaccine also prevented serious illness from Covid-19, with no serious cases and no hospital stays more than 22 days after the first dose.

The vaccine was approved by the UK Medicines Agency on December 30th and, as a shot made in the UK, makes up most of the country’s previously hailed successful vaccination program.

The UK is well on its way to vaccinating its four top priority groups (those over 70, residents and workers in nursing homes, frontline health and social workers and the most clinically vulnerable), which number around 15 million people by mid-February to have.

By February 1, over 9.6 million people had received a first dose of the vaccine, and just under 500,000 had received two doses, according to government figures.

Professor Andrew Pollard, chief investigator of the vaccine study at Oxford and co-author of the study, said, “These new data provide an important review of the intermediate data used by more than 25 regulatory agencies, including MHRA and EMA, to grant vaccine emergency approval.”

“It also supports the policy recommendation of the Joint Vaccination and Immunization Committee for a 12-week prime-boost interval as it seeks the optimal approach to initiation and assures us that people will be protected before 22 days after a single are dose of the vaccine. “

The researchers also hope to release data on the new coronavirus variants in the coming days and expect the results to be broadly similar to those already reported by other vaccine developers: that the current vaccines are effective against mutations in the virus.

Germany, France and Sweden currently do not recommend the AstraZeneca vaccine for people over 65 because of insufficient study data on this age group. However, the vaccine maker and the UK government have defended the sting, saying the data available shows it is safe and effective. Further analysis will be available shortly.

Categories
Health

Have You Had Covid-19? Examine Says You Might Want Solely One Vaccine Dose

Have You Had Covid-19? Study Says You May Need Only One Vaccine Dose

Shannon Romano, eine Molekularbiologin, kam Ende März mit Covid zusammen, ungefähr eine Woche nachdem sie und ihre Kollegen ihr Labor im Mount Sinai Hospital geschlossen hatten. Zuerst kam es zu schwächenden Kopfschmerzen, gefolgt von einem Fieber, das weiter anstieg, und dann zu qualvollen Körperschmerzen. „Ich konnte nicht schlafen. Ich konnte mich nicht bewegen “, sagte sie. “Jedes meiner Gelenke tut nur innerlich weh.”

Es war keine Erfahrung, die sie wiederholen wollte – niemals. Als sie Anfang dieses Monats für den Covid-19-Impfstoff in Frage kam, bekam sie den Schuss.

Zwei Tage nach ihrer Injektion entwickelte sie Symptome, die sich sehr vertraut anfühlten. “Die Art und Weise, wie mein Kopf schmerzte und mein Körper schmerzte, war die gleiche Kopfschmerzen und Körperschmerzen, die ich hatte, als ich Covid hatte”, sagte sie. Sie erholte sich schnell, aber die intensive Reaktion ihres Körpers auf den Stoß überraschte sie.

Eine neue Studie könnte erklären, warum Dr. Romano und viele andere, die Covid hatten, diese unerwartet intensiven Reaktionen auf den ersten Schuss eines Impfstoffs melden. In einer am Montag online veröffentlichten Studie stellten Forscher fest, dass Personen, die zuvor mit dem Virus infiziert waren, nach dem ersten Schuss häufiger über Müdigkeit, Kopfschmerzen, Schüttelfrost, Fieber sowie Muskel- und Gelenkschmerzen berichteten als diejenigen, die noch nie infiziert waren. Covid-Überlebende hatten sowohl nach der ersten als auch nach der zweiten Dosis des Impfstoffs weitaus höhere Antikörperspiegel.

Basierend auf diesen Ergebnissen, sagen die Forscher, benötigen Menschen, die Covid-19 hatten, möglicherweise nur einen Schuss.

“Ich denke, eine Impfung sollte ausreichen”, sagte Florian Krammer, Virologe an der Icahn School of Medicine am Berg Sinai und Autor der Studie. “Dies würde auch Personen vor unnötigen Schmerzen bewahren, wenn sie die zweite Dosis erhalten, und es würde zusätzliche Impfstoffdosen freisetzen.”

Eine zweite am Montag veröffentlichte Studie bestätigt die Idee. Die Studie umfasste 59 Beschäftigte im Gesundheitswesen, von denen 42 zuvor Covid hatten (mit oder ohne Symptome). Die Forscher bewerteten die Nebenwirkungen nicht, stellten jedoch fest, dass diejenigen, die zuvor infiziert waren, auf den ersten Stoß mit hohen Antikörperniveaus reagierten, vergleichbar mit den Mengen, die nach der zweiten Dosis bei Menschen beobachtet wurden, die noch nie infiziert waren. In Laborexperimenten banden diese Antikörper an das Virus und verhinderten, dass es in die Zellen eindrang. Um die Impfstoffversorgung zu erweitern, kommen die Autoren zu dem Schluss, dass diejenigen, die zuvor Covid hatten, in die Prioritätenliste aufgenommen werden sollten und nur eine Dosis des Impfstoffs erhalten sollten, während die Versorgung begrenzt ist.

Während einige Wissenschaftler dieser Logik zustimmen, sind andere vorsichtiger. Eine Änderung der Anzahl der Dosen könnte “einen wirklich kniffligen Präzedenzfall” schaffen, sagte E. John Wherry, Direktor des Instituts für Immunologie der Universität von Pennsylvania. “Wir nehmen keine FDA-Zulassungen für beispielsweise ein Chemotherapeutikum entgegen und werfen dann einfach den Dosierungsplan weg”, sagte er.

Dr. Wherry wies auch darauf hin, dass Menschen mit leichten Fällen von Covid offenbar niedrigere Antikörperspiegel aufweisen und möglicherweise keinen Schutz gegen ansteckendere Varianten des Virus haben. Es kann auch schwierig sein zu identifizieren, welche Personen zuvor infiziert wurden. “Die Dokumentation wird zu einem wirklich potenziell chaotischen Problem für die öffentliche Gesundheit”, sagte er.

Nebenwirkungen nach der Impfung sind völlig zu erwarten. Sie zeigen, dass das Immunsystem eine Reaktion auslöst und besser darauf vorbereitet ist, eine Infektion abzuwehren, wenn der Körper mit dem Virus in Kontakt kommt. Die Impfstoffe von Pfizer und Moderna können besonders gut eine starke Reaktion hervorrufen. Die meisten Teilnehmer an den Studien der Unternehmen berichteten von Schmerzen an der Injektionsstelle, und mehr als die Hälfte berichtete von Müdigkeit und Kopfschmerzen.

Die klinischen Studien mit den zugelassenen Impfstoffen von Pfizer und Moderna, an denen jeweils mehr als 30.000 Teilnehmer teilnahmen, legen nahe, dass die meisten Menschen nach dem zweiten Stoß die schlimmsten Nebenwirkungen haben. Und in der Moderna-Studie hatten Menschen, die zuvor infiziert waren, tatsächlich weniger Nebenwirkungen als diejenigen, die dies nicht getan hatten.

Aber anekdotisch hören Forscher von einer wachsenden Anzahl von Menschen wie Dr. Romano, die sich nach einem Schuss krank fühlten. “Sie beschreiben diese Symptome viel energischer”, sagte Dr. Wherry.

Das entspricht dem, was Dr. Krammer und seine Kollegen in ihrer neuen Studie gefunden haben, die noch nicht in einer wissenschaftlichen Zeitschrift veröffentlicht wurde. Die Forscher bewerteten die Symptome nach der Impfung bei 231 Personen, von denen 83 zuvor infiziert waren und 148 nicht. Beide Gruppen berichteten weithin über Schmerzen an der Injektionsstelle nach der ersten Dosis. Aber diejenigen, die zuvor infiziert worden waren, berichteten häufiger von Müdigkeit, Kopfschmerzen und Schüttelfrost.

Das Team untersuchte auch, wie das Immunsystem bei 109 Personen auf den Impfstoff reagierte – 68 davon waren zuvor nicht infiziert und 41 waren infiziert – und fand in der letzteren Gruppe eine robustere Antikörperantwort. Die Zahlen sind jedoch gering, und daher müssen die Schlussfolgerungen der Studie mit mehr Forschung weiter untersucht werden, sagten Experten.

Es ist nicht unbedingt überraschend, dass zuvor infizierte Personen möglicherweise intensivere Reaktionen erfahren. Beide Aufnahmen enthalten genetisches Material, das den Körper zur Herstellung von Spike-Proteinen anspornt, den knorrigen Vorsprüngen auf der Oberfläche des Coronavirus. Menschen, die bereits mit dem Virus infiziert wurden, haben Immunzellen, die darauf vorbereitet sind, diese Proteine ​​zu erkennen. Wenn die Proteine ​​nach der Impfung auftauchen, greifen einige dieser Immunzellen an und die Menschen fühlen sich krank.

Dr. Susan Malinowski, eine Augenärztin in Michigan, die im März Covid-19 hatte, hatte zweifellos das Gefühl, dass ihr Körper angegriffen wurde, nachdem sie den Moderna-Impfstoff erhalten hatte. Sie bekam den ersten Schuss vor dem Mittagessen am Silvesterabend. Beim Abendessen wurde ihr langsam schlecht. Sie verbrachte die nächsten zwei Tage elend im Bett.

„Ich hatte Fieber. Ich hatte Schüttelfrost. Ich hatte Nachtschweiß. Ich hatte überall in meinem Körper Schmerzen “, sagte sie. “Ich war nach dem Impfstoff tatsächlich kranker als mit Covid.”

Fragen zu schwereren Impfreaktionen bei Personen, die Covid bereits hatten, wurden auf einer Sitzung eines Expertenausschusses am 27. Januar gestellt, der die Zentren für die Kontrolle und Prävention von Krankheiten berät.

Dr. Pablo J. Sánchez, ein Komiteemitglied des Forschungsinstituts des Nationwide Children’s Hospital in Columbus, Ohio, bemerkte, dass er von Menschen gehört habe, die auf den Impfstoff schlechter angesprochen hätten als ihre früheren Erfahrungen mit Covid-19. Er schlug vor, eine Frage zur vorherigen Infektion zu den Informationen hinzuzufügen, die die CDC von den Impfstoffempfängern anfordert. “Es wird nicht gefragt”, sagte Dr. Sánchez. “Ich denke, das ist wirklich wichtig.”

Covid19 Impfungen >

Antworten auf Ihre Impfstofffragen

Bin ich in meinem Bundesstaat für den Covid-Impfstoff berechtigt?

Derzeit können mehr als 150 Millionen Menschen – fast die Hälfte der Bevölkerung – geimpft werden. Aber jeder Staat trifft die endgültige Entscheidung darüber, wer zuerst geht. Die 21 Millionen Beschäftigten im Gesundheitswesen des Landes und drei Millionen Einwohner von Langzeitpflegeeinrichtungen waren die ersten, die sich qualifizierten. Mitte Januar forderten Bundesbeamte alle Bundesstaaten auf, die Berechtigung für alle über 65-Jährigen und für Erwachsene jeden Alters mit Erkrankungen zu öffnen, bei denen ein hohes Risiko besteht, dass sie schwer krank werden oder an Covid-19 sterben. Erwachsene in der Allgemeinbevölkerung stehen am Ende der Reihe. Wenn Gesundheitsbehörden von Bund und Ländern Engpässe bei der Verteilung von Impfstoffen beseitigen können, sind alle ab 16 Jahren bereits im Frühjahr oder Frühsommer förderfähig. Der Impfstoff wurde bei Kindern nicht zugelassen, obwohl derzeit Studien durchgeführt werden. Es kann Monate dauern, bis ein Impfstoff für Personen unter 16 Jahren verfügbar ist. Aktuelle Informationen zu den Impfrichtlinien in Ihrer Region finden Sie auf Ihrer staatlichen Gesundheitswebsite

Ist der Impfstoff frei?

Sie sollten nichts aus eigener Tasche bezahlen müssen, um den Impfstoff zu erhalten, obwohl Sie nach Versicherungsinformationen gefragt werden. Wenn Sie nicht versichert sind, sollten Sie den Impfstoff trotzdem kostenlos erhalten. Der Kongress hat in diesem Frühjahr ein Gesetz verabschiedet, das es Versicherern verbietet, eine Kostenteilung wie eine Zuzahlung oder einen Selbstbehalt anzuwenden. Es bestand aus zusätzlichen Schutzmaßnahmen, die es Apotheken, Ärzten und Krankenhäusern untersagten, Patienten, einschließlich nicht versicherter Patienten, in Rechnung zu stellen. Trotzdem befürchten Gesundheitsexperten, dass Patienten in Schlupflöcher geraten, die sie für Überraschungsrechnungen anfällig machen. Dies kann bei Personen der Fall sein, denen zusammen mit ihrem Impfstoff eine Arztbesuchsgebühr berechnet wird, oder bei Amerikanern, die bestimmte Arten der Krankenversicherung haben, die nicht unter die neuen Vorschriften fallen. Wenn Sie Ihren Impfstoff von einer Arztpraxis oder einer Notfallklinik erhalten, sprechen Sie mit ihnen über mögliche versteckte Kosten. Um sicherzugehen, dass Sie keine Überraschungsrechnung erhalten, ist es am besten, wenn Sie Ihren Impfstoff an einer Impfstelle des Gesundheitsministeriums oder in einer örtlichen Apotheke erhalten, sobald die Aufnahmen breiter verfügbar sind.

Kann ich wählen, welchen Impfstoff ich bekomme?Wie lange hält der Impfstoff? Brauche ich nächstes Jahr noch einen?

Das ist zu bestimmen. Es ist möglich, dass Covid-19-Impfungen genau wie die Grippeimpfung zu einem jährlichen Ereignis werden. Oder es kann sein, dass der Nutzen des Impfstoffs länger als ein Jahr anhält. Wir müssen abwarten, wie dauerhaft der Schutz vor den Impfstoffen ist. Um dies festzustellen, werden Forscher geimpfte Menschen aufspüren, um nach „Durchbruchsfällen“ zu suchen – jenen Menschen, die trotz Impfung an Covid-19 erkranken. Dies ist ein Zeichen für eine Schwächung des Schutzes und gibt Forschern Hinweise darauf, wie lange der Impfstoff hält. Sie werden auch die Spiegel von Antikörpern und T-Zellen im Blut geimpfter Personen überwachen, um festzustellen, ob und wann ein Auffrischungsschuss erforderlich sein könnte. Es ist denkbar, dass Menschen alle paar Monate, einmal im Jahr oder nur alle paar Jahre Booster benötigen. Es geht nur darum, auf die Daten zu warten.

Benötigt mein Arbeitgeber Impfungen?Wo kann ich mehr erfahren?

Dr. Tom Shimabukuro von der CDC, der dem Ausschuss Sicherheitsdaten vorlegte, sagte, dass die Agentur das Problem untersucht. “Derzeit gibt es nur begrenzte Daten dazu, aber wir suchen nach Möglichkeiten, um bessere Informationen zu erhalten”, sagte er.

Menschen, die Covid hatten, scheinen „auf die erste Dosis zu reagieren, als wäre es eine zweite Dosis“, sagte Akiko Iwasaki, Immunologe an der Yale School of Medicine. Eine Dosis ist also wahrscheinlich “mehr als genug”, sagte sie.

Eine Anfang dieses Monats veröffentlichte Studie berichtete, dass das Überleben einer natürlichen Infektion einen Schutz von 83 Prozent vor einer erneuten Infektion innerhalb von fünf Monaten bot. “Zwei Dosen zusätzlich zu geben, scheint vielleicht übertrieben”, fügte sie hinzu.

Shane Crotty, Immunologe am La Jolla Institute for Immunology, wies darauf hin, dass eine intensivere Impfreaktion typischerweise einen besseren Schutz bedeutet. Wenn jemand eine große Reaktion auf die erste Dosis hätte, “würde ich erwarten, dass das Überspringen dieser zweiten Dosis sinnvoll wäre und dass die zweite Dosis wahrscheinlich unnötig ist”, sagte er.

Andere Immunologen schlagen jedoch vor, dass sich jeder an zwei Dosen hält. “Ich bin ein großer Befürworter der richtigen Dosierung und des richtigen Zeitplans, denn so wurden die Studien durchgeführt”, sagte Maria Elena Bottazzi, Immunologin am Baylor College of Medicine in Houston.

Und zwei Schüsse zu bekommen scheint keine Gefahr für diejenigen zu sein, die Covid hatten.

Dennoch wünscht sich der Augenarzt Dr. Malinowski, es gäbe weniger Fragen und mehr Antworten. Wenn die Nebenwirkungen von Impfstoffen bei bereits infizierten Menschen wirklich stärker sind, könnten Gesundheitsbeamte den Menschen einen Hinweis geben, sagte sie.

“Es wäre schön zu wissen, dass Sie vielleicht zwei Tage lang nicht aufstehen können”, sagte Malinowski. Sie hat beschlossen, nicht für eine zweite Dosis zurückzukehren.

Dr. Romano vom Mount Sinai Hospital wird voraussichtlich im Februar zum zweiten Mal erschossen und ist sich nicht sicher, was sie tun wird. “Meine Freunde, die Immunologen sind, wir haben das alle unter uns besprochen”, sagte sie. „Wahrscheinlich bekomme ich es. Aber ich möchte noch ein bisschen darüber nachdenken, bevor ich es tue. “

Denise Grady und Apoorva Mandavilli haben zur Berichterstattung beigetragen.

Categories
Business

Pfizer’s Vaccine Gives Sturdy Safety After First Dose

Pfizer’s Vaccine Offers Strong Protection After First Dose

WASHINGTON – The coronavirus vaccine, manufactured by Pfizer and BioNTech, offers strong protection against Covid-19 within about 10 days of the first dose. This emerges from documents released Tuesday by the Food and Drug Administration ahead of a meeting of their vaccine advisory group.

The result is one of several significant new results in the newsletters, which includes more than 100 pages of data analysis from the Agency and Pfizer. Last month Pfizer and BioNTech announced that their two-dose vaccine had a 95 percent effectiveness rate after two doses three weeks apart. The new analyzes show that protection starts much earlier.

In addition, the vaccine worked well regardless of the race, weight, or age of a volunteer. While no serious adverse events from the vaccine were identified in the study, many participants experienced pain, fever, and other side effects.

“This is what an A + certificate looks like for a vaccine,” said Akiko Iwasaki, an immunologist at Yale University.

On Thursday, the FDA’s Vaccine Advisory Panel will discuss these materials prior to a vote on whether to recommend approval of the vaccine by Pfizer and BioNTech.

Pfizer and BioNTech started a large-scale clinical trial in July that recruited 44,000 people in the US, Brazil and Argentina. Half of the volunteers received the vaccine and half the placebo.

New coronavirus cases in the vaccinated group of volunteers quickly subsided about 10 days after the first dose, according to a graphic in the educational materials. The number of cases increased steadily in the placebo group.

The vaccine’s swift action could benefit not only the people who receive it, but also the strained hospitals in the country, limiting the flow of new patients to intensive care units.

Despite the early protection provided by the first dose, it is unclear how long this protection would last on its own, which underscores the importance of the second dose. Previous studies have shown that the second dose of the Pfizer BioNTech vaccine gives the immune system a significant long-term boost that is seen with many other vaccines.

The effectiveness of the vaccine after the first dose, according to Dr. William C. Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, at about 52 percent. After the second dose, this value increases to about 95 percent. “Two doses of the vaccine offer maximum protection,” he said.

Many experts have raised concerns that the coronavirus vaccines might protect some people better than others. However, the results in the educational materials indicate no such problem. The vaccine has a high rate of effectiveness in both men and women, and similar rates in whites, blacks, and Latinos. It also worked well on obese people who are at higher risk of developing Covid-19.

Some vaccines for other diseases produce a weak immune response in older adults. However, Pfizer and BioNTech found that people over 65 received about as much protection from the coronavirus vaccine as younger people.

“I’ve never seen anything like it,” said Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic, on the vaccine’s robust response in the overweight and elderly.

Even if the vaccine is approved by the FDA, the study will continue. In the briefing documents, the companies said they would encourage people to stay in the study for as long as possible without knowing whether they received the vaccine or the placebo, so the researchers can continue to gather information on whether the vaccine is safe and effective.

The road to a coronavirus vaccine

Interesting facts about vaccines

Confused by all of the technical terms used to describe how vaccines work and study? Let us help:

    • Adverse event: A health problem that occurs in volunteers in a clinical trial with a vaccine or drug. An adverse event is not always caused by the treatment tested in the study.
    • Antibody: A protein produced by the immune system that can attach to a pathogen such as the coronavirus and prevent it from infecting cells.
    • Approval, Licensing, and Approval for Emergency Use: Medicines, vaccines and medical devices cannot be sold in the US for no profit approval by the Food and Drug Administration, also known as Licensing. After a company submits the results of clinical studies to the FDA for review, the agency decides whether the product is safe and effective. This process usually takes many months. If the country faces an emergency – like a pandemic – a company can file an application instead Emergency approvalthat can be granted much faster.
    • Background rate: How often does the general population experience a health problem called an Adverse Event? To determine whether a vaccine or drug is safe, researchers compare the rate of adverse events in one study to the background rate.
    • Effectiveness: The benefit of a vaccine compared to a placebo, measured in a clinical trial. For example, to test a coronavirus vaccine, the researchers compare how many people in the vaccinated group and the placebo group are receiving Covid-19. In contrast, effectiveness is the benefit that a vaccine or drug offers in the real world. A vaccine’s effectiveness can be found to be less or more effective than its effectiveness.
    • Phases 1, 2 and 3 studies: Clinical trials typically take place in three phases. Phase 1 studies typically involve a few dozen people to determine whether a vaccine or drug is safe. In Phase 2 trials that involve hundreds of people, researchers can try different doses and take more measurements of the vaccine’s effects on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of the vaccine or medicine by waiting to see how many people are protected from the disease it is intended to be used against.
    • Placebo: A substance with no therapeutic effect that is widely used in clinical trials. For example, to see if a vaccine can prevent Covid-19, researchers can inject the vaccine into half of their volunteers while the other half are given a placebo with salt water. You can then compare how many people are infected in each group.
    • Post-market surveillance: The surveillance that occurs after a vaccine or drug has been approved and regularly prescribed by doctors. This monitoring usually confirms that the treatment is safe. Rarely, side effects are noted in certain groups of people that were overlooked during clinical trials.
    • Preclinical Research: Studies that take place prior to the start of a clinical trial typically include experiments that test a treatment on cells or animals.
    • Viral vector vaccines: A type of vaccine that uses a harmless virus to deliver immune-stimulating ingredients into the human body. Viral vectors are used in several experimental Covid-19 vaccines, including those developed by AstraZeneca and Johnson & Johnson. Both companies use a cold virus called adenovirus as a vector. The adenovirus carries coronavirus genes.
    • Test protocol: A series of procedures that must be performed during a clinical trial.

The educational materials also provide a deeper look into the safety of the vaccine. In any large clinical trial, some people who receive vaccines have health conditions unrelated to the vaccine itself. Comparing their symptom rates with those of the placebo group, as well as background rates in a population, may indicate symptoms that a vaccine may actually cause.

The FDA concluded that there were no “significant imbalances” between the two groups in serious health complications known as adverse events. The agency found that four people in the vaccinated group had a form of facial paralysis called Bell’s palsy, with no cases in the placebo group. The difference between the two groups was not significant and the rate in the vaccinated group was not significantly higher than in the general population.

The new Pfizer analysis found that many volunteers who received the vaccine felt sick in the hours after the second dose, suggesting that many people may need to request a day off or be willing to rest until symptoms appear ease up. Among the 16 to 55 year olds, more than half developed fatigue and more than half also reported headaches. Slightly more than a third experienced chills and 37 percent had muscle pain. About half of those over 55 felt tired, a third had a headache, and about a quarter felt chills, while 29 percent had muscle pain.

“Taking a day off after the second dose is a good thing to anticipate,” said Dr. Iwasaki.

On Monday, Kristen Choi, a psychiatric nurse and health care researcher at the University of California at Los Angeles, released a firsthand report on the symptoms she experienced as a participant in the Pfizer BioNTech study, including chills, nausea and headaches and fever.

“Doctors need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could be very similar to Covid-19,” wrote Dr. Choi in JAMA Internal Medicine. She advised doctors to tell patients that these uncomfortable symptoms “are a sign that the vaccine is working despite the unfortunate similarities with the symptoms of the disease”.