Coronavirus Disease : Use Of Emergency Use Listing Procedure For Vaccines Against Covid
NOTE: this Q&A should be read as a supplement to the general Q&A document for the EUL
The EUL is used during public health emergencies. When products are not licensed yet , WHO will assess the quality, safety and efficacy data generated during development and conduct a risk-benefit assessment to decide if they can be used outside clinical trials.
Yes, all eligibility criteria are applicable. These are: the disease may cause an outbreak, epidemic or pandemic; there are no products available capable of eradicating or preventing the disease; products are manufactured in compliance with good manufacturing practices; and the applicant undertakes to complete the development of the product and apply for prequalification once it is licensed.
Yes. The procedure provides for a situation where the vaccine can be assessed after the public health emergency of international concern/pandemic has been declared. In this particular instance, WHO may select a group of experts from the pre-established roster to accelerate the assessment and issue a recommendation within a short timeline.
How soon can a vaccine against Covid-19 be assessed under the EUL? Does WHO need to evaluate a product that has already been approved by a WHO listed authority for use during public health emergencies ?
Odds Are Low But Some Fully Vaccinated People Have Been Infected With The Coronavirus
En español | A small number of Americans have been infected with the coronavirus after getting the COVID-19 vaccine. Called “breakthrough cases,” they have been making headlines recently, and they raise a question: What are your chances of getting COVID-19 if you are fully vaccinated?
The answer, studies suggest, is very low — probably just a fraction of a percentage point. Still, a few breakthrough cases are inevitable, even with highly effective vaccines.
For the latest coronavirus news and advice go to AARP.org/coronavirus.
“You will see breakthrough infections in any vaccination when you’re vaccinating literally tens and tens and tens of millions of people. So in some respects, that’s not surprising,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a March 26 White House COVID-19 briefing.
When it comes to what’s most important – preventing death – the vaccines were 100 percent effective in the trials.
A Centers for Disease Control and Prevention report published on April 2 found that the two-dose COVID-19 vaccine regimen prevented 90 percent of coronavirus infections two weeks after the second dose, which is when you are considered fully vaccinated. Of the 2,479 vaccinated people in the CDC study, just three had confirmed coronavirus infections after they were fully vaccinated.
/13can Medications Alter Covid Vaccine Response Is There A Need To Switch Medications
COVID vaccines work to generate a robust immune response upon injection. The potential effectiveness of the vaccines may come down to how well your body responds to it.
For the ones suffering from comorbidities, a slow immune response may be a possibility, in some extreme cases. Usage of some drugs may also make the body ‘busy’, leading to a delayed immune response to the vaccine.
That being said, if you are someone enlisted to get the vaccine in the coming while, there are certain medicines and therapies which may make you want to double-check with the doctor or postpone an appointment right now.
Can Vaccinated People Have No Symptoms And Still Spread The Virus To The Unvaccinated
This question is critical, but has not been rigorously studied yet. The data available so far indicate that vaccination in people who show no symptoms. In Moderna’s phase 3 clinical trial, a diagnostic test before the second dose of the vaccine showed 89.6 percent of asymptomatic and symptomatic cases were prevented by the first dose.
That result is “really encouraging,” says John Swartzberg, clinical professor emeritus at University of California Berkeley’s School of Public Health. “That’s going to make me feel, as a responsible person, that I can more safely be around other people.”
Fully Vaccinated People Experiencing Breakthrough Covid Infections: What To Know
The highly contagious delta variant is continuing to spread across the US, causing more fully vaccinated to become infected. But experts say that’s not a reason to question vaccines.
Even though they can contract the delta variant, vaccinated people are far less likely to end up in the hospital.
The highly contagious delta variant is continuing to spread across the US, causing a spike in COVID-19 infections — especially in areas with low vaccination rates. What’s different about this variant? It’s also breaking through to infect fully vaccinated people. Studies by the US Centers for Disease Control and Prevention say the delta infection has similarly high viral loads in vaccinated and unvaccinated people. So what does that mean as more of these breakthrough cases continue happening?
Currently, 167 million people in the US have been fully vaccinated, a little over half the country’s total population. The CDC’s research suggesting that vaccinated people infected with delta can also easily transmit the virus was the key factor motivating the new federal guidance that fully vaccinated individuals continue to wear masks indoors. At the same time, the CDC report underlines that the number of cases and deaths among fully vaccinated people is small compared with the unvaccinated.
Get the CNET Health and Wellness newsletter
/8when Is A Person Fully Vaccinated What Time Would It Be The Safest To Do So
The list of activities you can do come off as happy news, especially if you are someone prone to high vulnerability. That being said, to get the maximum protection from your COVID vaccine, it’s pertinent right now that you get both shots of the vaccine, at the correct time.
Since immunity with the COVID shot right now is still questionable, it’s crucial you practice utmost precaution till a given time to make the vaccine work for you. Here’s what doctors want you to know about the same.
Ensure that you do not miss out, or delay getting the second shot, which is crucial to safeguard you from the virus completely. Making sure that you get both doses of the same company is also crucial.
The ones who may have had COVID before may only require a single shot, which can be confirmed with the doctor. However, do make sure that you do practice certain precautions until 14 days after you get your shot-the time experts feel it takes for antibodies to fully develop. If you do indulge in risky activities, or ditch pandemic measures, such as mask-wearing, you place yourself at the high risk of still catching COVID.
How Long Will It Be Until Enough People Are Vaccinated To Go ‘back To Normal’
The easygoing world of 2019 may now be a distant memory, but with the vaccine rollout underway, a cautious sense of normalcy—eating at a restaurant, going to school, karaoke night with friends—seems within grasp.
So far, over 300 million people have been vaccinated worldwide. In the United States, around 30.7 million people have been fully vaccinated. Estimates suggest 90 percent of the U.S. population will be at least partially vaccinated by September at the current pace; researchers say between 75 and 80 percent of the population will need to get vaccinated before the country reaches herd immunity.
On the road to herd immunity, there will be signs that normalcy may be returning. Swartzberg says he will feel better as the number of new cases decreases, lessening the chance of being exposed to the virus.
“The way I see this playing out is that it’s going to be kind of a phase transition back to pre-pandemic times,” says Moss. The first step is to reduce cases, hospitalizations, and deaths through vaccination so thorough contact tracing can be implemented in an effective way. “Even though we talked about tracing, what happened was the case numbers were so high throughout the United States that it just overwhelmed that system,” he says.
Leifer is hopeful that the vaccine rollout can speed up with creative distribution and manufacturing plans. “My vision would be that we get there by the end of the summer, so that students can go back to school,” she says.
Questions Of Vaccine Effectiveness In People With Compromised Immune Systems
Vaccinations have played a critical role in bringing down those rates of new infection, hospitalization and death, easing pressure on vaccinated individuals to adhere to strict social distancing and behavioral measures. On May 13, Dr. Rochelle Walensky, who directs the CDC, announced that those who are fully vaccinated “can shed your mask.”
But an often-overlooked part of that new guidance cautions that people who have compromised immune systems — either because of a condition that affects the immune system directly, or because of treatment that works by suppressing the immune system — may still be at risk even after vaccination. For people whose immune systems don’t function normally, the vaccination process of training immune cells might not always play out successfully.
“If you have a condition or are taking medications that weaken your immune system, you may NOT be fully protected even if you are fully vaccinated,” the new guidance says. “Talk to your healthcare provider. Even after vaccination, you may need to continue taking all precautions,” including wearing masks.
That uncertainty has led some immunocompromised people to take antibody tests to check if their immune system is responding to the vaccines.
“I am hearing that immunocompromised individuals are doing that and some physicians are doing that for their patients,” Goodman said.
However You Should Exercise Your Arm To Reduce Pain In The Injection Site
The most common side effect, one you can practically guarantee you’ll experience, is pain at the injection site, which is why the Centers for Disease Control and Prevention advises you to “use or exercise your arm.” “Not necessarily go and lift weights, but just move it around,” Laurens told WTOP News. “Because the muscle, as it moves, helps to alleviate any stress and helps to move fluid into that area to help it recover more quickly.”
And to find out how many more shots are in your future, check out Moderna CEO Says This Is How Often You’ll Need A COVID Vaccine.
But You Should Be Really Well Protected Against Severe Illness And Death
Researchers and health care providers are basically allergic to absolute terms when it comes to talking about anything to do with human health and medicine, so you’ll really never hear one say something is 100%. But one shot of the mRNA vaccines seems to come pretty darn close to perfection in terms of preventing hospitalization and death.
“People who have received their first dose are dramatically well protected against hospitalization or death,” Pottinger said.
“In the studies, nobody who got vaccinated died. Obviously in the real world, we have many, many more people, but they’re still extremely, extremely effective at preventing severe disease and death,” added Valerie Cluzet, an infectious disease physician and medical director of infection control and antibiotic stewardship at Nuvance Health.
“That’s true certainly after your second dose, but probably also true for after the first dose,” she noted.
What Experts Saying About The Efficacy Of Vaccines Against Coronavirus
The breakthrough infections don’t mean the vaccines aren’t powerful.
“The effectiveness against severe disease is still substantial,” Fauci said during a White House press briefing July 22. “Get vaccinated. It offers good protection against disease.”
The main reason for breakthrough cases is the number of people who still haven’t been vaccinated. Once more people are fully vaccinated, the virus likely won’t infect as many people. Until then, the virus can continue to mutate and spread, creating new variants.
For more information, here’s everything to know about the delta variant. Also, here are more details about a potential COVID-19 booster shot, and info on the debate over whether fully vaccinated people should wear masks.
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.
/13the Medicines You Can And Cannot Take Along With Your Covid Vaccine
Coronavirus vaccines are being prioritized for elderlies and the ones over 45, with comorbidities.
From statins, anticoagulants, immunosuppressants to blood sugar pills, most people with comorbidities rely on maintenance medications to regulate vital functioning and thus, need to be used regularly.
However, with the arrival of COVID vaccines, there also have been some unfortunate discoveries. The usage of blood-thinning medications and strangely enough, derma fillers have been brought to question since they have been found to trigger some unique immune responses. Predisposition to some conditions or routine medicines may also make some develop unusual rashes and swellings.
Can You Still Pass The Virus To Others Even If Youve Been Vaccinated
Researchers are currently studying whether someone who’s been vaccinated can carry the virus and pass it on to others.
“It’s looking like the vaccine actually cuts down on the transmissibility of the virus. So if you’ve been vaccinated, there’s much less likelihood that you’re going to get exposed to the virus and be able to pass it on to others.”
She clarifies that some of the early data has not been peer reviewed yet, although it has been published. So researchers are still finalizing this information. But she says early research indicates that being vaccinated for COVID-19 can make you 90% less likely to have an asymptomatic infection and transmit the virus to those around you.
“It looks like the vaccine truly is not only protecting you, but it is protecting those around you.”
Its Important To Continue Masking Up And Maintaining Social Distance
Again, even after you’ve been fully immunized, “vaccine breakthroughs” are expected. That is one reason why some recommendations for fully vaccinated individuals have changed , while others have not budged.
It’s still important for everyone to mask up and maintain social distance. If you’re vaccinated, you should still be doing these things unless you’re in a private place with other vaccinated individuals or one other low-risk, unvaccinated household. If you’re not yet vaccinated, get whatever vaccine is available to you, whenever it’s available to you.
“We’re learning more and more that the vaccines also are preventing transmission, so not only are you protecting yourself, but you’re protecting others,” Cluzet said. “It’s personal health, but it’s also public health.”
Cdc Updates Domestic Travel Guidelines As More People Are Vaccinated
People who are partly vaccinated shouldn’t change their behavior, said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who is a member of the Food and Drug Administration’s vaccine advisory committee. Instead, they should sit tight until they have completed their vaccination series.
“It just frightens me that we have, in any sense, put out there the notion that are anything other than a two-dose vaccine,” Offit said.
The Centers for Disease Control and Prevention reported last week that the first doses of the Pfizer and the Moderna vaccines were 80 percent effective at preventing infection. The protection was measured two weeks after the first doses but before the second.
Can Coronavirus Symptoms Still Be Severe If You’re Fully Vaccinated
Someone who’s fully vaccinated has a much smaller risk of experiencing severe symptoms from COVID-19. People who’ve received all their doses of a vaccine are less likely to be hospitalized or die than those who haven’t been vaccinated, the CDC says. Vaccinated people typically see symptoms like a runny nose, which they mistake for a sign of a common cold, Rock said.
But that’s not to say serious cases can’t happen. The CDC says some fully vaccinated people can still be hospitalized and die. This can include people who have medical conditions that make them immunocompromised, Rock said, including those with cancer and people who’ve had organ transplants — in general, people who are more vulnerable. Data released in Israel by the Israeli Health Ministry shows that people who are unvaccinated are five times more likely to experience a severe infection, as opposed to the elderly who are fully vaccinated, Haaretz reported.
It’s possible for a fully vaccinated person to become infected with COVID-19.
Its Important To Stay On Top Of Changing Recommendations About Post
The CDC has been slowly changing its guidance about what people can do once they’re fully vaccinated. It’s OK to gather with a small group of friends outdoors while unmasked, for example, or to go on a walk or bike ride. If you’re fully vaccinated, it’s also generally safe to travel within the U.S. Our current COVID-19 vaccines really do confer robust protection, and health experts want everyone who has been really starved for normalcy, connection and physical affection to enjoy the freedoms vaccination offers.
Remember: the fact that there have been breakthrough cases “is not a vaccine failure by any stretch of the imagine,” Nelson said.
But there are still times when the CDC urges fully vaccinated Americans to take preventive measures like mask-wearing, maintaining social distance and hand-washing — particularly when you’re in a crowded or poorly ventilated space.
“If you’re around people who are not fully vaccinated, or you’re around someone who can’t be vaccinated … or you’re in a crowd or an area with poor ventilation, it’s probably important to keep doing those other mitigation measures,” Nelson said.
Experts are still learning about COVID-19. The information in this story is what was known or available as of publication, but guidance can change as scientists discover more about the virus. Please check the Centers for Disease Control and Prevention for the most updated recommendations.
The Who Is Right To Call A Temporary Halt To Covid Vaccine Boosters
Israel has begun rolling out a third dose of the Pfizer mRNA vaccine, even though the case for boosters has not yet been proved.Credit: Nir Alon/Alamy
The World Health Organization has called for a moratorium on COVID-19 boosters until the end of next month, with the aim of ensuring that at least 10% of people in all countries are vaccinated before extra doses are handed out. It makes a compelling argument. As Nature went to press, 58% of people in high-income countries had received at least one vaccine dose; in low-income countries this number stood at just 1.3%.
Moreover, the case for boosters has not yet been proved. Most COVID-19 vaccines currently in use remain extremely effective months after administration, particularly against severe disease and death. In a period of vaccine scarcity, the choice to dole out boosters must be guided by evidence of benefit, and consideration given to the cost of delaying the delivery of vaccines to vulnerable people and health-care workers in other countries. So far, there is little evidence that boosters are needed to protect the fully vaccinated.
Sadly, many countries are moving ahead with boosters regardless. Israel has begun giving third doses of Pfizer’s mRNA vaccine to people over 50 and other vulnerable groups. France, Germany, the United Kingdom and the United States are all planning to provide boosters to certain groups. In the United States, more than one million people have managed to get an unauthorized third dose.
Will I Be Compensated If I Have An Adverse Reaction To The Vaccine
While the Australian Government strongly supports immunisation, it is not compulsory. People, parents and carers maintain the right to choose whether to receive a vaccination.
The Government is not currently pursuing a no-fault COVID-19 vaccine injury compensation scheme. Serious side effects are extremely rare. If you think you may be having an adverse reaction, you should seek immediate medical care.
National coronavirus and COVID-19 vaccine helpline
If you need information about COVID-19, COVID-19 vaccines or help with the COVIDSafe app, call 1800 020 080. If you need assistance with booking a COVID-19 vaccine appointment, please note the call centre is unable to book appointments on your behalf.
/13people With Comorbidities Need To Be Vaccinated At The Earliest
Coronavirus can make a beeline for someone with frail immunity, which is a crucial reason why those with comorbidities should be inoculated at once.
Even with research and studies underway, taking a jab may do more harm than good.
According to Dr Rahul Pandit, Director-Critical Care, Fortis Hospitals Mumbai & Member-Maharashtra’s COVID Taskforce, prioritized, fast vaccination is the key right now to slowing the COVID mortality rate. “The high-risk vulnerable population – above 60 years and above 45 years with co-morbidities will bring down the mortality rate to ‘very low’, as currently, this group forms almost 90% of patients who succumb to the disease.”
Will Fully Vaccinated People Eventually Have To Get Booster Shots
Given the current circumstances, it’s likely a booster shot will be necessary. The Food and Drug Administration is expected to authorize a COVID-19 booster shot by the weekend, but the CDC will need to also give authorization before booster shots can be distributed. The shot would be a third dose of the Pfizer and Moderna vaccines.
Scientists are continuing to study the immunity of fully vaccinated people to get a better idea of how well the vaccines protect them. Moderna is currently researching when a booster shot may be necessary. For instance, Rock said vulnerable people who don’t have a robust immune system — such as those with chronic medical conditions — may need an additional shot.
Pfizer says it’s working on a booster shot for its COVID-19 vaccine to enhance immunity among those who’ve already received both doses. The UK is also prepping for booster shots, with vaccine experts in the UK saying a booster shot may be needed before winter.
Its Looking Pretty Likely That Breakthrough Cases Are Less Severe
The CDC is being cautious about overselling this point, saying that “there is some evidence that vaccination may make illness less severe.”
About 27% of the breakthrough cases the CDC is aware of have been asymptomatic infections, for example. This is not to say that really serious outcomes are impossible. There have been 835 hospitalizations among those who are fully vaccinated against COVID-19 , and there have also been 132 deaths — though again, not all of those were necessarily directly related to COVID-19.
“The vaccine still elicits some immune response to help your body fight infection and that translates into a more mild infection,” Nelson said. “There’s probably a lower likelihood of transmitting, too.”
Can I Cross State Borders Without Restrictions If I Am Vaccinated
Based on expert medical advice, mandatory quarantine with COVID-19 testing at frequent intervals is the best strategy for incoming international travellers.
Before you travel interstate, you should check your local state and territory website for directives, hotspot information and travel restrictions:
Ask Your Doctor About Getting Other Vaccines At Your Appointment
Contrary to previous CDC advice on waiting 14 days between getting the COVID-19 vaccine and any other vaccine, experts are now saying receiving the COVID-19 vaccine in tandem with others shouldn’t be harmful. According to a CNN report, an expert on the CDC’s birth defects division said at a recent meeting with the CDC’s Advisory Committee on Immunization Practices that there isn’t evidence to suggest a reason to space out vaccines.
This is a big deal for kids who are behind on their booster shots because of pandemic restrictions, CNN reports. The CDC now recommends kids ages 12 to 15 get a Pfizer vaccine , and The American Academy of Pediatrics stated that in addition to recommending all children ages 12 and up get the COVID-19 vaccine, it supports giving “multiple immunizations” at the same time.
If you are an adult and would like to schedule your COVID-19 vaccine appointment on the same day you’re scheduled to get another vaccine, check with your doctor beforehand. The CDC will likely update its official recommendation on the vaccine waiting period soon.