After prior data showed that one in four patients with B-cell malignancies did not produce detectable antibodies after receiving their first two doses of the COVID-19 mRNA vaccine, new findings are more promising for these patients.
In results from a larger pool of data presented at the 63rd ASH Annual Meeting, 43% of the patients (109 out of 245) with blood cancers who did not produce antibodies after being administered their first two doses produced antibodies after receiving a third full dose of the mRNA vaccine.
In addition to that, the balance of the patients from 245 up to 699 those 454 patients that were making some antibodies before, after the third vaccination made a very large amount of antibodies in general, up to the maximum amount of antibodies that the assay is capable of detecting. So, they are well protected, said Lee Greenberger, chief scientific officer of the Leukemia & Lymphoma Society (LLS), in an interview with CURE.
Greenberger also pointed out the important distinction here between a COVID-19 booster and a third dose the patients with blood cancer in this study received a third full strength vaccination dose of whatever mRNA vaccine is available to them, rather than a booster dose.
In particular, patients with a blood cancer received the 100-microgram dose of the Moderna vaccine and not the 50-microgram dose that non-immunosuppressed individuals received in the general population. Patients with a blood cancer who received the third dose of the Pfizer vaccine received the same strength as the general population.
Why Patients With B-Cell Malignancies Produce Fewer Antibodies
The researchers, whose data was reported from the LLS National Patient Registry, included a larger number of patients with B-cell malignancies in the study to analyze this population specifically due to their challenges in producing antibodies to prior COVID-19 vaccine doses.
The reason that these patients typically do not see a stimulation of anti-spike antibodies which block entry of COVID-19 into the cells is because their cancer type or their cancer therapy depletes the immune systems B-cells, and these cells are responsible for making antibodies that fight viruses.
So if you don't have a high number of B-cells, or the functionality is suppressed, they won't make antibodies, Greenberger said. And therefore, if you give (them) a vaccine, you just dont make antibodies.
These types of cancers include chronic lymphocytic leukemia (CLL), and some of the most common non-Hodgkin lymphomas: diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma (MCL) and Waldenstrm macroglobulinemia.
However, in patients with other types of blood cancers, including myeloid forms of leukemia, Hodgkin lymphoma and multiple myeloma, detectable antibody rates ranged from 75% to 100%. These cancer types also typically respond favorably to the first two doses of COVID-19 vaccines.
Certain Cancer Treatments May Affect Antibody Production
Treatments such as Bruton tyrosine kinase (BTK) inhibitors, CD19 CAR-T cell therapies and anti-CD20 antibody treatments that deplete B-cells may weaken the immune response to the COVID-19 while a patient is on them, or even for several months after therapy is complete.
There is also a component that the disease itself suppresses B-cell function and that also, even patients who don't have any of those therapies may have impaired B-cell responses and fail to make anti-spike antibodies, Greenberger said.
Of the 320 patients with CLL in the study who are commonly treated with these therapies, 65% of patients who did not receive therapy for two years prior to receiving the vaccine were able to produce antibodies after the third dose. Conversely, patients in this population who did receive these therapies in the last two years had less chance of benefit, with just 23% to 41% producing antibodies post-third dose.
On the other hand, patients who received a certain type of antibody infusion as part of their cancer treatment may obtain an added benefit with the COVID-19 vaccine. Intravenous immunoglobulin (IVIG) infusion, which is typically given to patients on BTK inhibitors, anti-CD20 antibodies or CAR-T cell treatments to replace the lost antibodies, has an increased level of COVID-19 anti-spike antibodies. The reason for this is that IVIG comes from people who donate blood plasma, and many more of the donors are now either vaccinated or have had COVID-19 and thus their plasma contains antibodies.
The LLS study found that some patients treated with this infusion had unusually high levels of antibodies after receiving the third vaccine dose, even among those who had no antibody production after their first two doses.
Patients Should Continue Protective Strategies, Regardless of Vaccination or Antibody Status
Its important for patients with blood cancer to know, Greenberger stressed, that the COVID-19 vaccine is safe for them to receive.
The safety (of the vaccine) is not an issue, he said. You may make anti-spike antibodies to the vaccination, so its important to get them, including the third vaccination.
However, getting the vaccine no matter the dose should not prevent patients from continuing their preventive strategies against the virus.
They should mask up, they should observe distance rules, Greenberger said. And they need to be careful. Particularly patients who have B-cell malignancies, (they) should consider themselves not fully protected, and be careful.
Antibody Cocktails May Help Patients After COVID-19 Exposure
For patients who need to be extra careful about their COVID-19 exposure, Greenberger noted that antibody cocktails may be a helpful option.
Three antibody cocktails and one single antibody are useful to prevent or reduce symptoms of COVID-19 infections. The bamlanivimab and etesevimab antibody cocktail, as well as the casirivimab and indevimab antibody cocktail is used to treat mild to moderate COVID-19.
Both cocktails received additional FDA emergency authorization for use in patients who may be at high risk of progression to severe COVID-19 infections (post-exposure prophylaxis).
The single antibody, Xevudy (sotrovimab), is also FDA-authorized for use in the latter indication.
Recently, the tixagevimab and cilgavimab cocktail received FDA emergency authorization for immunocompromised patients that do not have COVID-19 but are at high risk of poor outcomes if they contract COVID-19 (pre-exposure prophylaxis).
The utility of these antibodies against the Omicron variant is currently under investigation and is likely to be very important in those patients who fail to either make any antibodies or sufficient antibodies after three mRNA vaccinations, according to Greenberger.
In addition, there are studies with fourth vaccinations, he said. Remember that the FDA has basically told patients who are immunosuppressed, after they get the third vaccination, six months later, they should get another vaccination the fourth vaccination, that is an option.
He added that the LLS registry will be following patients who would like to participate and are eligible to receive their fourth dose.
And sometimes it's kind of like starting a car that won't want to start, Greenberger explained. Well, if you try starting it enough, it will eventually start and turn over. And that's what we're hoping for some of these patients who don't make antibodies.
Beyond that, patients who are on therapies with long-lasting B-cell suppressive effects will see these effects eventually time out and their B-cells may be able to start responding to vaccinations again.
For more news on cancer updates, research and education, dont forget tosubscribe to CUREs newsletters here.
'We tend to forget we're dealing with humans': Health experts mixed on new NFL COVID-19 protocols USA TODAY
D.C. is expanding the Health Department's free coronavirus testing program on Wednesday to include COVID-19 antigen tests that people can pick up to perform at home to get results within 15 minutes.
Well have these at eight libraries; well have initially 1,000 kits per library per day, said Patrick Ashley, senior deputy director at DC Health. Individuals can pick up two kits, which is a total of four tests per person, per day, at the library.
Each of the citys eight Wards will have a library providing the free, rapid tests to people showing proof of residency.
And these are in addition to our current Test Yourself program that we have operating at 36 libraries throughout the district, he said, referencing the citys current PCR testing program.
PCR test results developed in laboratories take a few days, but provide very definitive answers as to whether someone currently has COVID-19. Antigen tests are slightly less specific but give immediate results, so people can take action if needed to help reduce the spread of the virus in the community.
Most importantly, the reason to take an antigen test is if youre symptomatic, Ashley said.
And we want you to take an antigen test kit within the first couple of days of you being symptomatic because we know that antigen tests are far more likely to show a positive result, a reliable positive result within the first couple of days of symptoms.
COVID-19 tests of all sorts are not always easy to get.
It is so frustrating to not be able to find a PCR test or rapid test anywhere, saidNicole West, who arrived at the Shaw Neighborhood Library on Tuesday, after all available tests were distributed.
Everybodys going to see family for the holidays and friends and just in the interest of trying to be as safe as possible make sure that were all tested. And its not going as wed hoped, she said with a sigh.
D.C.s Test Yourself program involves people picking up a PCR test to administer at home before returning it to a drop off location to await laboratory results.
Weve used them before. Were really grateful the librarys doing this actually, Kinara Flagg said, while waiting in line to receive a test on Tuesday at the Shaw Neighborhood Library. Its made testing and drop-off pretty easy.
Flagg and her family members have used the tests repeatedly to rule out COVID-19 being responsible for cold-like symptoms and after being in contact with someone who tested positive.
They typically received test results within two or three days four days was the longest.
Sam, who preferred his last name not be used and is also from the Shaw neighborhood, attested to the convenience of the librarys PCR tests.
Its a great setup they have here, Sam said. He needed testing previously to go on honeymoon. They say 72 hours for results. I think we got ours back in like 28, 30 we needed them pretty quick. So that was a good thing.
The quick-result antigen tests dont involve documentation of results like the PCR tests do, but Ashley said thats crucial information people should report on the DC Health website.
Unlike traditional laboratories, which are required to report this information to us, because youre taking these at home, we have no knowledge of you taking those tests, Ashley said. And so for our surveillance purposes and understanding what the disease is doing in the community, its really important both those positive and negative results.
You can find a full list of testing locations offered by various community entities on the D.C. Department of Health website.
Courtesy DC Health
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December 21, 2021
As we enter a new year, a new variant has emerged, winter conditions are pushing people indoors, and holiday gatherings and travel are increasing potential virus exposure and movement. With this in mind, we are eagerly watching to see how the state of the pandemic evolves as we begin 2022.
Fortunately, we are in a very different place than we were in January 2021: much of our population is vaccinated, and there are many viable therapeutics that are already available or expected to be available soon for outpatient treatment of COVID-19.
Join us on Tuesday, January 11, 2022, for the 19th installment of our monthly Virtual Grand RoundsCOVID-19 Therapeutics - What Oral Medications are on the Way? for an update from Californias State Epidemiologist Erica Pan, M.D. on the status of COVID-19 in California. We will also hear from other experts on the evolving landscape of COVID-19 therapeutics and prepare us for the oral medications in the pipeline.
The grand rounds webinars arefree and open to all interested clinicians. Participants can receive1.5AMA PRA Category 1 CreditsTM. Clinicians likely to encounter COVID-19 in their practice settings (e.g., front line physicians, nurse practitioners or physician assistants) are encouraged to join the monthly case-based presentations, which will include expert panel discussions and audience participation.
If you are unable to attend the live webinar, they will be available for on-demand playback atcovidroundsca.org.
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the California Medical Association and California Health and Human Services Agency. CMA is accredited by ACCME to provide continuing medical education for physicians.
The California Medical Association designates this live activity for a maximum of 1AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Gov. Larry Hogan is expanding hours at testing sites and urging Marylanders to get boosters as hospitalizations are projected to reach a pandemic-high of 2,000.
Gov. Larry Hogan is expanding hours at testing sites and urging Marylanders to get boosters as hospitalizations are projected to reach a pandemic-high of 2,000 early next year.
If the predicted number of hospitalizations is correct, it will exceed Marylands peak of 1,950 hospitalizations last January, according to Dr. Ted Delbridge, the executive director of the Maryland Institute for Emergency Medical Services Systems.
The Maryland National Guard is being mobilized to expand hours at testing sites in Anne Arundel and Prince Georges counties, Hogan also said Tuesday, to help meet demand. The state will provide school systems will $30 million in additional funding to buy tests.
So many of us are undoubtedly feeling dj vu. I want to urge Marylanders not to panic, Hogan said.
This is not March of 2020. We have the tools and resources in place to keep ourselves and our loved ones safe. We must remain vigilant. We cannot let our guard down.
The updates come after Hogan tested positive for COVID-19 on Monday; he hosted the news conference from the governors house and said hes experiencing cold-like symptoms.
Hogan is also introducing emergency legislation to help hospital systems, including $100 million of additional funding to address staffing shortages at Maryland hospitals and nursing homes.
Of that additional funding, $50 million will go to hospitals and nursing hopes to expand COVID testing, treatments and vaccines. The other $50 million will be used to stabilize hospitals workforce and staffing needs.
Hogan said all nursing homes will offer COVID-19 therapeutic treatments to residents during an outbreak.
Heath officials are following a new directive as some reach capacity. Hogan said if hospitalizations reach 1,200, then some non-urgent medical procedures will be reduced. If hospitalizations reach 1,500, hospitals will implement their pandemic plans.
But, Hogan said, the state can only do so much.
We also need the federal government step up and do whatever it takes, including invoking the Defense Production Act to dramatically expand the availability of testing to the American people, Hogan said. Every American who wants a test should be able to get it fast.
Hogans announcements come as he said hospitalizations have reached 1,392, an increase of 180% in the last month.
Delbridge said that 75% of hospital emergency departments are currently alerting Marylands emergency medical services system that theyre at capacity and should be avoided if at all possible.
Hospitalizations are expected to peak in mid- to late January. Hogan said this is the same time period the flu is expected to peak.
The state is administering more than 50,000 tests per day.
Hogan said the state has administered over 10 million vaccines.
The remaining 9% of Maryland adults who arent vaccinated make up more than 75% of COVID-19 hospitalizations in the state.
I know that theres been confusing guidance from the federal government on this, Hogan said. But what with what we know about these dangerous variants, nobody should think of a booster as just a bonus or an extra dose.
The University of Maryland medical center is expected to surpass the highest number of COVID-19 hospitalizations since the start of this pandemic during the new surge, said Dr. David Marcozzi, a professor at the universitys school of medicine and the incident commander for the medical system.
COVID-19 metrics increase,prompting Health and Human Services Board to discussface coverings
NEW HANOVER COUNTY, NC Locally, COVID-19 cases are increasing, and at todays meeting, the Health and Human Services (HHS) Board voted to discuss and revisit the face coverings health rule for indoor public places and will hold a public hearing at its regular meeting on Tuesday, January 18, 2022 at 8 a.m.
New Hanover Countyspercent positivityrateis currently 6.7percent, and 592new cases of COVID-19 have been reported over the last 14 days for an average of42.3cases per day. This is an increase since before Thanksgiving, when the percent positivity rate was 2.7 percent and there was an average of 14.5 new cases over the last 14 days. This continued increase is what prompted the board to schedule the public hearing and discussion.
The Health and Human Services Board is going to discuss COVID-19 metricsandtrends, data compared to last year at this time, and other statistical analysis as it relates to where we are in thepandemicafter the new yearand whether we need to reinstate our face coverings health rule, said Health and Human Services Board Chair Dr.LeShondaWallace.This is a proactive conversation that the board plans to have,given our current increases in case countsandhospitalizationsand the rapid spread Omicron,to see where we are and if additional protective measures like face coverings are needed.TheOmicron and Deltavariants are actively circulating,soweencourageour communitytomake good choices over the holidays and wearface coveringswhen in crowded spacesandget tested if you plan to visit family. The more we can do proactively, the better we will all be.
The board also voted to form a subcommittee to work with staff, including thenewly formedPandemic Operations Team, to develop a clear methodology of statistical analysis, including hospital, CDCand NCDHHS data, in order to make a data-informed decision related to the face coverings health rule and other protective measures related to the pandemic.
TheJanuary 18 publichearing will be an opportunity for the board to reviewcurrentdata, receive comments from the public, and determine whether the previously implemented health rule that requiresface coverings in all indoor public places within New Hanover County should be reinstated. The previous health rule that will be considered can beviewed here.
Themeetingwill be held in the multipurpose room ofthe Health and Human Services building,located at 1650 Greenfield Street in Wilmington.In addition, the public mayview the meeting live atNHCTV.com,youtube.com/NewHanoverCoand Spectrum Cable channel 13; or listen to the meetingby dialing415-655-0003andwhen promptedfor a meeting ID, press808 594 284, then the pound sign (#).
Comments can be submittedin advance of the January meetingonline herethroughnoononFriday, January 14. The public can also attend the public hearing in person and speak about the proposed rule on January 18 at 8 a.m. Comments must be limited to 3 minutes each and a total of 45 minutes will be allotted for public comments during the hearing, which is in keeping with HHS Board operating procedures.
Based on statute, at least 10 days notice must be given in advance of any board action on a health rule, so the HHS Board voted to be proactive in order to discuss and potentiallytake actionon the rule at its next meeting.
Being vigilant this holiday season is important in limiting the spread of COVID-19 in the community.Foranyone who has been exposed to someone with COVID or is showing symptoms related to COVID, testing resources, including a list of testing sites, can be foundhere. Additionally, information on self-testing can be foundon the CDCs website here.
As a reminder, the New Hanover County Health and Human Services Vaccination Clinics at 1650 Greenfield Street and Independence Mall will be closed December 23-27. Both vaccination clinics will reopen on December 28. The clinics will also be closed on December 31 and reopen on January 3 forregular operating hours.
Appointments to receive a vaccine at the HHS clinics are highly recommended and can be made by visitingTakeMyShot.NC.gov.
View additional COVID-19 information and dataatHealth.NHCgov.com.
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Back to news overview
2:44 PM ET
Greg WyshynskiESPN
The NHL and NHL Players' Association have come to an agreement to not participate in the 2022 Winter Olympic men's hockey tournament in Beijing, multiple sources told ESPN.
The NHL and NHLPA had negotiated Olympic participation in 2022 and 2026 into the newest collective bargaining agreement after NHL players did not participate in the 2018 Olympics in Pyeongchang, South Korea. The only caveat for the Beijing Olympics, scheduled for February 2022, was if the current NHL regular season was "materially impacted" by COVID-19 postponements. As of Dec. 21, the NHL has postponed 50 games because of outbreaks on teams and has paused its season through Christmas, apparently meeting that threshold.
The NHL had until Jan. 10 to opt out of Olympic participation without financial penalty and the NHLPA said it expected a decision on participation to be made before that date.
A formal announcement on opting out of the Games is expected within the next 24 hours.
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Attention will now turn to using the scheduled break for the Olympics -- Feb. 6-22 -- to reschedule games. The NHL All-Star Game is still scheduled for Feb. 5.
Sources said that rescheduling could include currently postponed games or potentially moving up games that are scheduled for later in the season, but there could be a lack of arena availability during the break. While the NHL asked arenas not to book events during the break in case players didn't participate in the Olympics, many buildings booked concerts and other events, seeking to make up for lost revenue during the pandemic.
It's expected there will still be some semblance of a break in the schedule. Predators general manager David Poile told ESPN 102.5 The Game in Nashville that he believed there would be a "compromise" for the amount of time players will have off, with games being crammed into the final week of that break. He also floated the idea that the regular season could be extended by a week.
News of the expected Olympic decision was met with frustration and sadness from players who would have played in the Beijing Games.
"I've been fortunate enough to be part of two [Olympics]," Penguins captain Sidney Crosby said. "I definitely feel for the the guys who have missed numerous opportunities. It's not something where it's the next year or you push it a couple of months. These are experiences of a lifetime that you don't get very many of as an athlete."
Two Winnipeg Jets players who appeared headed for Team USA expressed their regret on Tuesday.
"Yeah, that sucks. I think everyone was looking forward to this," Kyle Connor said. "We made it a big part of our collective bargaining agreement as the players, to bring the Olympics back. Whether it's about different circumstances about going to China with COVID and everything, I think it would have been a great tournament."
Goalie Connor Hellebuyck, a potential starter for the Americans, was worried about his status for the 2026 Olympics in Italy.
"If the next one's in four years, I'll be 32," he said. "I know I'll be playing my best hockey, but it's going to be a different story."
The Olympic rosters will now be filled by a combination of amateur players and professionals playing in leagues outside of the NHL. That could include North American minor leagues and overseas professional leagues like Russia's KHL. This was the setup for teams in the Pyeongchang Olympics, where the Olympic Athletes from Russia won gold.
Boulder, Colo. Tuesdays Kansas mens basketball game against Colorado at CU Events Center was canceled less than two hours before tipoff because of positive COVID-19 tests within the Colorado program.
Fans were turned away from the arena before being let in at about the same time that Colorado announced on its social media platforms that the game had been called off. A statement from Kansas Athletics indicated that the two programs mutually agreed to cancel the game.
Our top priority since the start of the pandemic has been the health and safety of our student-athletes, staff and the community," CU Athletic Director Rick George said in a statement Tuesday night. While were disappointed for our student-athletes and fans to have to cancel the game, both schools agreed this is the best decision.
A Colorado fan sits outside of CU Events Center in Boulder, Colorado, trying to figure ...
Photo by Matt Tait
Kansas coach Bill Self told reporters at KUs team hotel in Boulder that none of the Jayhawks were positive as of Tuesday and that he was disappointed but not devastated that the game had been canceled. So, too, Self said, was Colorado coach Tad Boyle, who told Self throughout the day Tuesday that he was still hoping to play.
Tad said, Bill, if we have seven and they say we can play, we want to play, Self said Tuesday evening. But this is not an important game in the big scheme of things. I actually agree totally with the decision that was made. It was their doctors, our doctors, everybody.
Initially, it was just one positive test within the CU program. But after the rest of the CU team was tested, more positive test results surfaced, prompting the cancellation.
Self said the two programs decided earlier Tuesday that they planned to go as long as possible, to try to see if the game could still be played. That meant a drop-dead time of 5:45 p.m. before a final call was required. CUs additional positive test results were in before that time and the game was canceled just after 5 p.m. mountain time, before KU had left the hotel for the arena.
Self said he first heard the official word from Associate Athletic Director Sean Lester and he noted that Boyle was trying to call through while Lester and Self were talking.
According to a statement released by Kansas Athletics, there is no plan to reschedule the game. But Self did not rule out the possibility of KU adding another game to its schedule somewhere down the road to make up for the lost opportunity on Tuesday night.
Self also noted that this was not the first time a college sporting event had been canceled this season and he predicted that it also would not be the last time.
Its going to screw up your conference season, he said. I just hope it doesnt screw it up where it takes away the fans and what makes college basketball so great. Everybody can deal with a weeks pause. I just dont know how itll be (with) reduced capacities and if we start doing all the things we did last year because of whats transpiring.
According to Self, the Jayhawks were not able to get out of town on Tuesday night and were scheduled to stay in Boulder through the night and return home to Kansas on Wednesday. Everyone but senior forward Mitch Lightfoot was scheduled to return to Lawrence with the team and then they would all go their separate ways for the holiday break from there before returning to campus on Dec. 26. Lightfoot road home with his family from Colorado to Phoenix.
Based on Tuesdays practice and what he had seen from his team since last Saturdays close-call victory over Stephen F. Austin, Self said the seventh-ranked Jayhawks (9-1) were looking forward to getting back onto the court.
We were prepared to play today, he said. As poorly as we played Saturday, and as telling as the film was for all the guys, you could tell they were anxious to go play.
The Jayhawks are now scheduled to be off until Dec. 29, when they are scheduled to play host to Harvard in the final game before the start of Big 12 Conference play on Jan. 1.
Self said the Jayhawks would continue to take every precaution possible in the meantime, and he touted the positive impact of vaccines in helping keep the COVID-19 virus under control.
Even though the illness is serious, I think statistics show that those that have been vaccinated carry far less risks than those who have not, Self said. Were going to try to be as precautionary as we can and probably put in some protocols that look similar to last year, but I hope it doesnt feel similar to last year.
The (omicron) variant is going to spread like wildfire. Were all going to get it. The good news is if you are vaccinated and boosted, the symptoms of getting it are very mild compared to those who arent. At least our team is vaccinated and for the most part boosted. I dont know what to do. One positive shouldnt shut you down. But in this situation, multiple positives and theres symptoms more importantly (players) are going home (for the holidays) and there are some individuals who may be a little bit compromised from an immune system standpoint; this was not that important to play this game.
Self also said KU recently decided to cancel its annual holiday clinic, scheduled for next Monday, for this exact reason.
We had 500 (kids) sign up, he said. And if you put athletes around 500 kids theres probably a chance somebody in the groups got COVID. And then one of our guys gets it and you could have to potentially miss guys or miss games.
The Technical Advisory Group for Emergency Use Listing listed Nuvaxovid (NVX-CoV2373) vaccine against COVID-19 and Covovax (NVX-CoV2373) vaccine against COVID-19 for emergency use on 20 December 2021 and 17 December 2021 respectively.
The Novavax vaccine will be manufactured in two different facilities. In Europe, the vaccine will be manufactured under the trade name Nuvaxovid and has been approved by the European Medicines Agency, and in India, the vaccine will be manufactured by Serum Institute of India under the trade name Covovax and has been approved by the Drugs Controller General of India.
TheWHO Strategic Advisory Group of Experts on Immunization (SAGE) has issuedinterim policy recommendationsfor the use of the Novavax (NVX-CoV2373) vaccine.This article provides a summary of those interim recommendations.
For the purposes of this article, the vaccine will be referred to as Novavax (NVX-CoV2373).
The background documents are also availablehere.
Where COVID-19 vaccine supplies are limited, priority should go to health workers at high risk of exposure and older people.
Countries can refer to theWHO Prioritization Roadmap and theWHO Values Frameworkfor guidance.
The vaccine is not recommended for people younger than 18 years of age. Safety and immunogenicity data for under-18s are currently being generated but until such data are sufficiently available and can be further reviewed, vaccination of individuals in this age group is not recommended.
Data regarding the safety and efficacy of the use of Novavax (NVX-CoV2373)vaccine in pregnant women is not yet available. However, based on previous evidence from other protein-based vaccines during pregnancy, efficacy is expected to be comparable to non-pregnant women of a similar age.
WHO recommends the use of the COVID-19 vaccine in pregnant women when the benefits of vaccination to the pregnant woman outweigh the potential risks. To help pregnant women make this assessment, they should be provided with information about the risks of COVID-19 in pregnancy, the likely benefits of vaccination in the local epidemiological context, and the current limitations of safety data in pregnant women. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination.
Vaccination is recommended for people living with conditions that have been identified as increasing the risk of severe COVID-19, including cardiovascular disease, respiratory disease, diabetes, liver disease, obesity and neurodevelopmental and neurodegenerative conditions.
The vaccine can be offered to people who have had COVID-19 in the past. Available data shows that symptomatic reinfection from the same variant is unlikely for up to 6 months after infection. Those with documented infection may therefore choose to delay vaccination to nearer the end of this period, especially when vaccine supply is limited, to allow others priority for vaccination.
WHO recommends the same use of Novavax (NVX-CoV2373) vaccine in breastfeeding and non-breastfeeding women. Data are not available on the potential benefits or possible risks of the Novavax (NVX-CoV2373)vaccine to breastfed children. However, as Novavax (NVX-CoV2373) vaccine is not a live virus vaccine, it is biologically and clinically unlikely to pose a risk to the breastfeeding child. WHO does not recommend discontinuing breastfeeding because of vaccination.
Persons living with human immunodeficiency virus (HIV) or who are immunocompromised are at higher risk of severe COVID-19 disease. There are not enough data at present to allow assessment of the efficacy or safety of this vaccine for people living with HIV. It is possible that the immune response to the vaccine may be reduced, which could lower its clinical effectiveness. In the interim, however, given that the vaccine is nonreplicating, people living with HIV that is well controlled may be vaccinated with the standard primary series of 2 doses, when part of a group prioritized for vaccination.
Individuals with a history of anaphylaxis to any component of the vaccine should not take it.
Persons with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from acute illness and the criteria for ending isolation have been met.
Anyone with a body temperature over 38.5C should postpone vaccination until they no longer have a fever.
Most children and adolescents are at very low risk of severe COVID-19. Safety and immunogenicity data are currently being generated for those aged under 18 years. Until this data are available, vaccination of persons under the age of 18 is not recommended.
SAGE recommends the use of the Novavax (NVX-CoV2373)vaccine as 2 doses (0.5 ml) given intramuscularly. The two doses should be administered with an interval of 3-4 weeks.
SAGE recommends that severe and moderately immunocompromised persons should be offered an additional dose of vaccine. This is due to the fact that this group is less likely to respond adequately to vaccination following a standard primary vaccination series and are at higher risk of severe COVID-19 disease.
SAGE accepts two heterologous doses of WHO EUL COVID-19 vaccines as a complete primary series. However, there is limited evidence available on the use of Novavax (NVX-CoV2373)in a heterologous schedule.
It is impossible to compare vaccine head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have achieved WHO Emergency Use Listing are highly effective in preventing severe disease and hospitalization due to COVID-19.
SAGE has thoroughly assessed the data on the safety and efficacy of the vaccine and has recommended its use for people aged 18 and above. The WHO EUL process also evaluates the quality of manufacturing along with safety and efficacy.
Safety data is currently limited for persons above 65 years of age (due to the small number of participants of this age group in clinical trials). However, the trial data indicate that the vaccine has an acceptable safety profile for this age group and WHO recommends the vaccine for use in persons aged 65 years and over.
The efficacy of Novavax (NVX-CoV2373)has been assessed in three Phase 2 and Phase 3 trials. Of the two Phase 3 trials, both found that the efficacy of the vaccine against mild, moderate, and severe disease is 90%.
In a Phase 3 study conducted in the USA and Mexico during a period in which multiple variants (Alpha, Beta and Delta) were in circulation, vaccine efficacy against mild, moderate, or severe COVID-19 was 90%
In view of these findings, WHO recommends the use of Novavax (NVX-CoV2373)vaccine according to the WHO Prioritization Roadmap, even if currently recognized Variants of Concern (VOC) are present in the country. If new VOCs emerge for which vaccine performance is compromised, these recommendations will be updated accordingly. There are insufficient data still for Omicron.
As there is not currently sufficient evidence to date to evaluate the impact of the vaccine on transmission, public health and social measures must continue, including use of face masks, physical distancing, handwashing, appropriate ventilation, and other measures as appropriate in particular settings, depending on the COVID-19 epidemiology and potential risks of emerging variants. Government advice on public health and social measures should continue to be followed by both vaccinated and unvaccinated individuals. SAGE will update this advice as information on the impact of vaccination on virus transmission and indirect protection is assessed.
KANSAS CITY, Mo. The surge of COVID-19 cases associated with the omicron variant has many across Kansas City scrambling for COVID-19 tests ahead of holiday gatherings.
There are several testing resources Kansas Citians can access to help line up a drive-thru test.
On the Missouri side, PrepareMetroKC.org has a list of COVID-19 testing by day, including events in Cass County, the Samuel U. Rodgers Health Center, University Health Lakewood and the Jackson County Health Department.
On the Kansas side, the Kansas Department of Health and Environment maintains an interactive map on its website showing several dozen testing sites.
The Missouri Department of Health and Senior Services offers a similar listing of local testing locations.
Many individual county and city health departments also maintain websites offering COVID-19 testing information:
Jackson County, MissouriJohnson County, KansasWyandotte County, KansasKansas City, MissouriClay County, Missouri Cass County, MissouriPlatte County, Missouri Leavenworth County, Kansas
