Results on the effectiveness of the University of Oxford and AstraZeneca experimental COVID-19 vaccine are expected in the coming weeks. Justin Tallis/Agence France-Presse/Getty Images
The experimental COVID-19 vaccine being developed by AstraZeneca and the University of Oxford produces a robust immune response in older adults, data from mid-stage trials have shown.
The Phase 2 results, published on Thursday in medical journal The Lancet, suggest that the age groups most at risk of death or serious illness from coronavirus may be able to build immunity. The peer-reviewed findings, based on a study of 560 adults, showed that older adults aged 56-69 and over 70 had a similar immune response to younger adults aged 18-55.
However, with larger Phase 3 trials still ongoing, there was no update on the effectiveness of the vaccine candidate in preventing COVID-19. The university said the first efficacy data were possible in the coming weeks. Shares in the British drugmaker AZN, +0.03% edged 0.3% higher in early trading.
Read:Moderna shares soar premarket after COVID-19 vaccine candidate achieves 94.5% efficacy in Phase 3 trial
Earlier this week, U.S. drugmaker Pfizer PFE, +0.84%, which is working with Germanys BioNTech BNTX, +2.21%, said that a final analysis of Phase 3 trial data showed its COVID-19 vaccine was 95% effective. On Monday, U.S. biotech Moderna MRNA, +2.26% said its own experimental vaccine was 94.5% effective, based on interim data from late-stage trials. Both are expected to apply for U.S. regulatory authorization within days.
Researchers said Phase 2 findings from the Oxford and AstraZeneca vaccine were encouraging, as studies show people tend to have decreasing immune responses to vaccines with age.
Older adults are a priority group for COVID-19 vaccination, because they are at increased risk of severe disease, but we know that they tend to have poorer vaccine responses, said Dr. Maheshi Ramasamy, investigator at the Oxford Vaccine Group, in a statement.
Read:BioNTech and Pfizers COVID-19 vaccine is surprisingly effective, though experts question what effectiveness will look like in the real world
We were pleased to see that our vaccine was not only well tolerated in older adults; it also stimulated similar immune responses to those seen in younger volunteers. The next step will be to see if this translates into protection from the disease itself.
Volunteers in the Phase 2 trial received two doses of the vaccine candidate, called ChAdOx1 nCov-2019, or a placebo meningitis vaccine. No serious adverse health events related to the vaccine were seen in the participants, the researchers said.
The results were consistent with Phase 1 data reported for healthy adults aged 18-55 earlier this year.
The report on the AstraZeneca and University of Oxford vaccine was less likely to move the dial as, unlike the other major vaccine updates so far, there was no detail on its efficacy, said Russ Mould, AJ Bell investment director.
There are almost a dozen coronavirus vaccines in final-stage testing, with Moderna and Pfizer showing promising preliminary results. Scientists welcome the crowded field because different types of vaccines will be needed to meet global demand. (Nov. 17) AP Domestic
Dr. Anthony Fauci, the nations leading infectious disease expert who has guided the U.S. through the pandemic, projectedAmericans could expect their first doses of an approved coronavirus vaccine as early as April.
Front-line health care workers are expected to get their first doses by the end of December or early January. After prioritizing people at risk of infection or severe disease, the healthy general populationcan expectfirst doses of a vaccine starting inApril and through July if all continues on track, Fauci told the USA TODAY Editorial Board on Wednesday.
If most of the population is vaccinated by summer and fall, Fauci said, people can start looking forward to returning to pre-pandemic normalcy.
Then you can start talking about this umbrella or blanket of protection on society that would diminish dramatically the risk of a person being exposed or even being infected, he said. When so many people are protected, thats when you get into the real herd immunity.
But to get there, vaccine hesitancy must be addressed, he said, particularly among people of color who have a historic distrust of the nation's medical system.
Polls show that among racial and ethnic groups, Black Americans are the most hesitant to get a vaccine once one becomes available, and their skepticism is rising fast. In one September survey, only 32% of Black adults said they would get a vaccine, down from 54% in May.
That's why Moderna, the company developing a COVID-19 vaccine with the federal government, made a concerted effort toincludeminority representation in clinical trials, Fauci said.
We said that we want representation in the elderly, white, brown, Black, people with underlying conditions, so that we can get a feel if its effective across the board, he said,and not just a "white man's vaccine."
Outreach bytrusted community leaders also is key, Fauci said.
Traveling for the holidays?: Dr. Anthony Fauci urges Americans to 'think twice'
'It's not real': In South Dakota, which has shunned masks and other COVID rules, some people die in denial, nurse says
Fauci also stressed candidate vaccine data is reviewed by outside, independent advisory boards made up of career scientists, who then present objective findings to the Food and Drug Administration, whichauthorizes avaccine's use.Afterward,the data will be published for anyone to review.
Fauci emphasized the importance of transparency, consistency and effectively communicating that developing a COVID-19 vaccine is governed by independent science and data notoutside forces.
I understand because of a lot of that noise that comes out of Washington that some of these governors or mayors ... have concern about the process, he said, referring to states that have created committees to vet a vaccine as an extra layer of scrutiny.
When it gets approved by the FDA I would take the vaccine and I would recommend that my family take the vaccine.
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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TOKYOBreakthroughs in Covid-19 vaccine trials are giving a boost to the organizers of next summers Tokyo Olympics, who are looking into vaccine suppliers and planning to encourage athletes to get their shots.
Still, local organizers remain publicly cautious about whether enough vaccines will be available in time, and they are leaving room for the Games to proceed regardless. If vaccines are in short supply, it would be hard to justify prioritizing young athletes with low risk of serious illness.
Australian...
The diminutive diva's $1 million donation to Covid-19 research was partly used to fund Moderna's promising Covid-19 vaccine -- something she didn't even know until her name appeared among other sponsors in a preliminary report on the vaccine.
In media appearances on Tuesday, Parton was beaming with pride and excitement at the news.
"Praise the lord!" she told "Today" hosts Hoda Kotb and Jenna Bush Hager. "I'm just very grateful that this is happening, and if I had anything to do with it, that's great."
"I just felt so proud to have been part of that little seed money that will hopefully grow into something great and help to heal this world," she said. "I'm a very proud girl today to know I had anything at all to do with something that's going to help us through this crazy pandemic."
SIOUX FALLS, S.D. (KELO) Two companies have announced promising preliminary results of COVID-19 vaccines. However, there are still many questions surrounding the vaccine and getting it to South Dakotans.
One Sioux Falls doctor is sharing his perspective on the outlook of South Dakota receiving a COVID-19 vaccine. Dr. Wendell Hoffman is an Infectious Disease Specialist at Sanford Health.
The news about the Pfizer and Moderna vaccines is very, very encouraging. I mean, if these numbers play out in the 90 percent plus range, this will be nothing short of spectacular, Hoffman said.
According to the Associated Press, Pfizer said its vaccine was more than 94% effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyze and no breakdown provided of those peoples ages.
Moderna, Inc. also announced that its experimental vaccine appears to be 94.5%effective as well.
But just because a vaccine is produced doesnt mean everyone will receive it right away.
According to the South Dakota Secretary of Health Kim Malsam-Rysdon, the vaccinations will go first to frontline health care workers who care for COVID patients in hospitals and long-term care settings. She went on to say the next group will include residents in long-term care facilities.
The problem is that were not going to have widespread vaccine available into the broad population for a number of months. We may have some vaccine by the end of the year, but 20 to 30 million doses, even if we get that much, in a population of 350 million potentially who might benefit from a vaccine. So thats my point about building a bridge to the vaccine, and the bridge is those mitigating strategies, Hoffman said.
The mitigating strategies Hoffman is referring to includes social distancing, wearing a mask, good hand hygiene and staying home when youre sick.
I mean youd almost have to be living under a rock not to have heard this, Hoffman said.
Hoffman said having a vaccine would eliminate a multitude of concerns for people both financially and health-wise.
Its devastating. People are suffering, and its not that theyre so much afraid of dying. Its that theyre afraid of, How am I going to pay my bills? How am I going to get back to work?' Hoffman said.
Keep reading
Your Guide To Coronavirus
KELOLAND News is covering the COVID-19 pandemic. This is your guide to everything you need to know to prepare. We also have the latest stories from across the globe feeding into this page.
SIOUX FALLS, S.D. (KELO) Two companies have announced promising preliminary results of COVID-19 vaccines. However, there are still many questions surrounding the vaccine and getting it to South Dakotans.
One Sioux Falls doctor is sharing his perspective on the outlook of South Dakota receiving a COVID-19 vaccine. Dr. Wendell Hoffman is an Infectious Disease Specialist at Sanford Health.
The news about the Pfizer and Moderna vaccines is very, very encouraging. I mean, if these numbers play out in the 90 percent plus range, this will be nothing short of spectacular, Hoffman said.
According to the Associated Press, Pfizer said its vaccine was more than 94% effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyze and no breakdown provided of those peoples ages.
Moderna, Inc. also announced that its experimental vaccine appears to be 94.5%effective as well.
But just because a vaccine is produced doesnt mean everyone will receive it right away.
According to the South Dakota Secretary of Health Kim Malsam-Rysdon, the vaccinations will go first to frontline health care workers who care for COVID patients in hospitals and long-term care settings. She went on to say the next group will include residents in long-term care facilities.
The problem is that were not going to have widespread vaccine available into the broad population for a number of months. We may have some vaccine by the end of the year, but 20 to 30 million doses, even if we get that much, in a population of 350 million potentially who might benefit from a vaccine. So thats my point about building a bridge to the vaccine, and the bridge is those mitigating strategies, Hoffman said.
The mitigating strategies Hoffman is referring to includes social distancing, wearing a mask, good hand hygiene and staying home when youre sick.
I mean youd almost have to be living under a rock not to have heard this, Hoffman said.
Hoffman said having a vaccine would eliminate a multitude of concerns for people both financially and health-wise.
Its devastating. People are suffering, and its not that theyre so much afraid of dying. Its that theyre afraid of, How am I going to pay my bills? How am I going to get back to work?' Hoffman said.
Keep reading
Your Guide To Coronavirus
KELOLAND News is covering the COVID-19 pandemic. This is your guide to everything you need to know to prepare. We also have the latest stories from across the globe feeding into this page.
Once a vaccine is approved, the race is on to overcome the biggest logistics challenge in history to distribute it around the globe
By Carrie Arnold
IN KALAMAZOO, Michigan, millions of vials of a covid-19 vaccine may soon be rolling off production lines. There are still many hurdles to leap before that vaccine the candidate from US drug company Pfizer and its German partner BioNTech or any other is approved and distributed, but governments, manufacturers and shipping firms around the world have already spent months preparing for what happens next.
That comes down to a simple but easily overlooked fact: a vaccine by itself is useless. Vaccines dont save lives, says Kelly Moore at the Immunization Action Coalition in the US. Vaccination does.
When a covid-19 vaccine is approved, it will trigger a staggeringly complex chain of events. These events must occur in perfect lockstep using a global supply chain that needs to reach even the planets most remote areas the same supply chain that left parts of the world in desperate need of things like disposable gloves and protective equipment just months ago.
The scale and magnitude of what were talking about doing is just unparalleled, says Orin Levine, director of vaccine delivery at the Bill & Melinda Gates Foundation. The list of potential catastrophes has been keeping Levine up at night for months. But overcoming these logistical challenges is what it will take to end the pandemic. And the key to overcoming complexity is planning and planning early, says Levine.
Exactly how many people need to be vaccinated to end the pandemic depends on how effective the vaccine is, and how long the immunity it provides lasts (see Vaccine front runners ). Seth Berkley, head of Gavi, an international group that promotes
The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.
The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.
The Pfizer vaccine, which uses innovative mRNA technology, was the first to publish an early analysis from its phase 3 trials involving 43,000 people worldwide. That analysis of 94 cases of Covid illness showed more than 90% efficacy and caused celebration around the world as it appeared clear that a vaccine was at least possible against the coronavirus that has wreaked havoc in peoples lives and countries economies.
The final results have been published just a week later, based on 170 people in the trial who fell ill with the disease. The new data is even better, with 95% efficacy which means that the vast majority of those who developed symptoms and were confirmed as Covid cases had not been given the Pfizer experimental vaccine. Only eight had been given the vaccine, while the other 162 were in the placebo group.
In further excellent news, a good immune response was consistent across age, gender, race and ethnicity demographics and the jab had over 94% efficacy in those aged over 65, Pfizer said. That is remarkable, because many vaccines do not work so well in older people, whose immune systems weaken with age.
Of those taking part in the trial, 42% were from diverse ethnic backgrounds and 41% were aged between 56 and 85, which is also important as people from BAME groups have been disproportionately affected by the virus.
Ten of the cases resulted in severe illness, as opposed to mild symptoms, and only one of those had been given the experimental vaccine. No serious side-effect issues have been reported, although 2% of people said they suffered a headache and fatigue.
This week, the US company Moderna announced that its vaccine, which also uses mRNA, had 95% efficacy based on interim data. They will now be looking to publish final results and a safety analysis that will allow them to submit for regulatory approval.
Pfizer/BioNTech confirmed they would go within days to regulators around the world for emergency authorisation based on their final data and also manufacturing quality data. They have undertaken to deliver 50m doses of the vaccine this year, with up to 1.3bn next year. The UK has pre-ordered 40m doses and is likely to get a small amount this year. Europe has ordered 200m while the US has ordered 100mn.
We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against Covid-19 can be achieved very fast after the first 30 g [microgam] dose, underscoring the potential of BNT162 to provide early protection, said Uur ahin, the CEO and co-founder of BioNTech.
These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against Covid-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.
I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.
Prof Trudie Lang from the Nuffield Department of Medicine at Oxford University, said the data that has been released looked very positive.
This is a remarkable and very reassuring situation that we find ourselves in. To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science.
Having worked on vaccine development in several diseases such as Malaria, TB and Ebola, I am really encouraged. The progress here, the faster ways of working and the new technologies developed can be taken forward into other vaccine programmes and benefit other diseases.
Two COVID-19 vaccines might be nearing the finish line, but scientists caution it's critical that enough people volunteer to help finish studying other candidates in the U.S. and around the world.
Moderna Inc. and competitor Pfizer Inc. recently announced preliminary results showing their vaccines appear more than 90% effective, at least for short-term protection against COVID-19.
If those early results hold up and U.S. regulators agree the shots are safe, emergency use of small, rationed supplies could start in late December. Other countries with contracts for early doses would undertake their own reviews.
But multiple vaccines will be needed to meet global demand and help end the pandemic, raising concern that studies that still need to sign up thousands of volunteers could run short if people wait for an already OK'd option instead.
We dont want to see that happen, said Dr. James Cutrell, an infectious disease expert at UT Southwestern Medical Center in Dallas.
Supplies aside, other COVID-19 vaccines under development may work differently in different populations and "we likely will benefit from having a menu of vaccine options, Cutrell said.
We still need volunteers, stressed National Institutes of Health Director Francis Collins, urging Americans to sign up.
Additionally, participants in the Moderna and Pfizer studies who originally got dummy shots would almost certainly be offered the real vaccine if the U.S. Food and Drug Administration allows emergency use. But no one knows how long protection would last, meaning those studies also must continue to track recipients somehow.
Its one thing to be effective two months after your last vaccination and another thing to be effective a year later, said Dr. Jesse Goodman of Georgetown University, a former director of the FDA's vaccine division. Its going to be really important to complete these clinical trials and the trials of the other vaccines so we can make comparisons.
The promising Moderna and Pfizer news bodes well for some of their competitors, said Dr. Anthony Fauci, the U.S. government's top infectious disease expert whose team at NIH helped develop the Moderna candidate.
Those shots target the spike protein that studs the surface of the coronavirus, and the early results prove that's enough to generate a protective response, Fauci said. Conceptually this looks good for other spike-focused vaccines made in different ways.
Heres a scorecard of the frontrunners in the global vaccine race:
GENETIC CODE VACCINES
The Moderna-NIH vaccine and the candidate developed by Pfizer and its German partner BioNTech arent made with the coronavirus itself, meaning theres no chance anyone could catch it from the shots.
Instead, the vaccines are made with a brand-new technology that injects a piece of genetic code for the spike protein. That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, enough to prime the immune system to react if it later encounters the real virus.
There are no licensed mRNA vaccines for people, so scientists had no idea if or how well the COVID-19 candidates might work.
Both manufacturers are working to scale up production in factories in the U.S. and Europe. They cant simply partner with other vaccine companies to take on some of the work because the technology is so different than the way most of todays shots are made.
It is not a very easy or quick swap, said Moderna CEO Stphane Bancel.
TROJAN HORSE VACCINES
A different way to target the spike protein: Use another, harmless virus to carry the spike gene into the body. Once again, the body produces some spike protein and primes the immune system.
Britains Oxford University and AstraZeneca are making their version of this viral vector vaccine with a cold virus, or adenovirus, that normally infects chimpanzees. Studies of tens of thousands of people are underway in the U.K., U.S. and several other countries.
Johnson & Johnson is using a human adenovirus for its version, and is the only option in advanced U.S. testing aiming to show if a single dose rather than two would be enough.
Chinas government authorized emergency use of CanSino Biologics adenovirus shots in the military ahead of any final testing. Russia likewise began offering an adenovirus vaccine ahead of late-stage tests.
PROTEIN VACCINES
Novavax makes its vaccine candidate by growing harmless copies of the coronavirus spike protein in the laboratory and packaging them into virus-sized nanoparticles.
There are protein-based vaccines against other diseases, so its not as novel a technology as some of its competitors. Novavax has begun a large final-stage study in Britain, and is set soon to begin another in the U.S.
KILLED VACCINES
Spike-focused vaccines arent the only option. Making vaccines by growing a disease-causing virus and then killing it is a tried-and-true approach its the way Jonas Salks famed polio shots were made.
China has three so-called inactivated COVID-19 vaccine candidates in final testing in several countries, and has allowed emergency use in some people ahead of the results. An Indian company is testing its own inactivated candidate.
Safely brewing and then killing the virus takes longer than newer technologies. But inactivated vaccines give the body a sneak peek at the germ itself rather than just that single spike protein.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.
