The drug maker Pfizer announced Monday that its coronavirus vaccine appears to be able to prevent more than 90 percent of people from getting COVID-19a major development that the company has described as a great day for science and humanity. Pfizer, which developed the vaccine with the German drugmaker BioNTech, said its preliminary analysis shows that its vaccine is more than 90 percent effective in preventing the disease, and no serious safety concerns have been observed during tests on 43,500 people in six countries. According to The New York Times, Pfizer now plans to ask the Food and Drug Administration for emergency authorization and said it will have manufactured enough doses to immunize 15 to 20 million people by the end of the year. The Times notes the company released only sparse details from the trial and that long-term safety information was still to be collected.
The Dow Jones Industrial Averages futures index shot up 1500 points on the early morning news.
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Pharmaceutical company Novavax announced on Monday that it has been granted a fast track designation for its COVID-19 vaccine candidate by the Food and Drug Administration (FDA), according to MarketWatch.
The companys vaccine candidate will be expedited with the help of the government agency in a bid to accelerate the development of an effective and safe COVID-19 vaccine.
Officials at Novavax expect its candidate, called NVXCoV2373, to complete its phase 3 trials based in the U.S. and Mexico by the end of November.
"While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally," Gregory M. Glenn, president of Novavax Research and Development, said in a statement.
This announcement comes on the heels of Pfizer, another COVID-19 vaccine contender, announcing Monday that its efficacy data saw a 90 percent prevention rate for its candidate during phase 3 trials.
Both Novavax and Pfizer have received federal funding as part of Operation Warp Speed, an initiative established by the Trump administration that provided funding to pharmaceutical companies to develop COVID-19 vaccines in a record-breaking time frame.
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Novavax COVID-19 vaccine is on the fast track by FDA | TheHill - The Hill
COVID-19 vaccine is glimmer of hope, but doctors say it will take awhile to help WWMT-TV
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COVID-19 vaccine is glimmer of hope, but doctors say it will take awhile to help - WWMT-TV
And this surveillance must continue even after approval, said Penns Ellenberg. If one of the vaccines provokes an unforeseen reaction in, say, 1 out of 10,000 recipients, on average, then it very possibly might not show up in an initial trial group of 15,000 or 20,000 people, she said.
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Multiple COVID-19 vaccines may be available at the same time
Multiple COVID-19 vaccines may be available at the same time
MILWAUKEE - As the world waits for a coronavirus vaccine, UW Health is among 80 hospitals nationwide participating in the final phase of the AstraZeneca trial.
Getting rid of this worldwide pandemic is getting the vaccine, said Dr. William Hartman, UW Healths principal investigator of the trial.
In other countries, the AstraZeneca injection has been shown to create COVID-19 neutralizing antibodies. The focus of its two-year study is how long those antibodies last.
Who stays immune and who stays immune the longest, explained Hartman.
If effective in reducing COVID-19 cases by at least 50 percent and approved by the U.S. Food and Drug Administration, the AstraZeneca vaccine could be released before its study is over.
I think we're moving a little more briskly and a bit more efficiently but it's not like corners are being cut, said Dr. Jim Conway of the UW Health Immunization program. Only when the science is clear does the FDA even get a shot at reviewing it.
Conway says we may end up with a dozen different vaccines available at the same time. The first vaccines may be available by the end of 2020.
I think getting it into the general population will take well into 2021, said Conway.
The Wisconsin Department of Health Services (DHS) is making a similar prediction. In its COVID-19 Vaccination Plan, it says multiple vaccines from different manufacturers may be available at the same time.
DHS also says immunity is likely to require two doses, either 21 or 28 days apart.
I think it's pretty clear that health workers are probably that first wave, said Conway.
Also included in Wisconsins first phase of distribution are people over age 65, those living in long-term care facilities, and other essential workers.
Phase two of distribution includes other critical populations -- and eventually the general public in phase three.
To administer the vaccine, hospitals will need enough needles, syringes, and alcohol prep pads. Two of the most promising vaccines, from Pfizer and Moderna, also require ultra-cold storage in minus 80-degree Celsius freezers.
Your average place out in the communities doesn't have access to those kinds of freezers, said Conway.
UW Health is still seeking another 1,000 volunteers for its trial from all racial and ethnic backgrounds. It hopes to eventually be doing 25 injections per day.
It's an awesome experience. This is something that encompasses everyone in the world right now, said Hartman.
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The DHS plan says the vaccine will be procured and distributed by the federal government at no cost to providers or patients.
Conway predicts every person will need to be vaccinated to see a complete return to life as it was pre-COVID-19.
He says that could take until 2023 or longer if people refuse the vaccine or there are supply shortages.
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DHS: Multiple COVID-19 vaccines may be available at the same time - fox6now.com
Ninety-percent is fantastic," he said. If you think about the way that vaccines work, you know you can see anywhere between 50 and 85 percent. Eight-five percent is a really, really good vaccine, and that means you get the shot and you develop an immunity to whatever youre getting a shot for.
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Charleston physician confident COVID-19 vaccine will be available next year - Live 5 News WCSC
NEW YORK(Reuters) - Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway. Some companies had suggested early trial data could be ready for release in October, but have since pushed that back to November and December.
A volunteer receives an injection from a medical worker during the country's first human clinical trial for a potential vaccine against the novel coronavirus, at the Baragwanath hospital in Soweto, South Africa, June 24, 2020. REUTERS/Siphiwe Sibeko
The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives worldwide:
Who is furthest along?
U.S. drugmaker Pfizer Inc PFE.N with German partner BioNTech SE 22UAy.F, and U.S. biotech Moderna Inc MRNA.O could have early data in November. Britain-based AstraZeneca Plc AZN.L, in conjunction with University of Oxford, and Johnson & Johnson JNJ.N say they are on track to deliver data for their vaccines this year.
What happens in these trials?
The companies are testing their vaccines against a placebo - typically saline solution - in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.
Why are data reports delayed beyond original predictions?
The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.
Pfizer, for instance, believes it may know if its vaccine works once 32 people contract COVID-19 in the 44,000-person trial, as long as the overwhelming majority of those infected had received the placebo.
But drugmakers have said an insufficient number of infections prior to the recent spikes in cases slowed their ability to present data earlier. Pfizer in October said it did not expect to have usable trial data until late November due to slow infection rates. It had previously suggested that would happen in October.
AstraZeneca said a slowdown in infections during the summer delayed its UK trial and that it expected to have results by the end of the year. Its timeline was also extended by a pause to investigate an illness in a UK trial participant.
After a slowing of infections in late summer and early autumn, COVID-19 cases were rampant again in October and early November, setting daily records in the United States and Europe as the weather cooled and people moved indoors. Experts have suggested that trial participants may also have been more careful to avoid contracting COVID-19 than the general population knowing they may have received a placebo.
How will we know if the vaccine works?
The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Some regulators have said that vaccines must demonstrate at least 50% efficacy - meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.
When will regulators decide?
Regulators will review the vaccines after the companies have enough data to submit applications seeking emergency use authorization (EUA) or formal approval. The earliest they could decide is in December because Moderna and Pfizer/BioNtech do not expect to have enough safety data until the second half of November. U.S. regulators have asked that participants be watched for side effects for two months after receiving a final vaccine dose. AstraZeneca could provide a look at late-stage data by the end of the year. UK officials said there is a slight possibility they could decide on that vaccine in late December.
Regulators for Europe, the United Kingdom and Canada are considering data on a rolling basis, as it becomes available. They expect to do speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.
Could these be the first approved coronavirus vaccines?
Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics 6185.HK and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia's Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data in November. Russia has also given the vaccine to at least hundreds of "high-risk" members of the general population.
Reporting by Carl ODonnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanovo in Moscow; Editing by Caroline Humer and Bill Berkrot
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DANVILLE -- The chief executive officer of Geisinger sees a vaccine as a light at the end of the tunnel in the battle against the coronavirus.
But, Dr. Jaewron Ryu, citing the increased number of COVID-19 cases, said it might be a little premature to say that weve turned the corner.
Speaking at a news conference Friday, he stressed the need to take all precautions like wearing a mask, avoiding large gatherings and social distancing to reverse the upward trend.
The coronavirus is out there in the community and that means anybody can get it, he said. We have to be super vigilant."
Ryu cited the change in weather, fewer daylight hours, events being moved indoors and the flu season as contributing reasons for the increase in COVID-19 cases.
He believes a safe, effective vaccine will be available in the first of 2021 but said it could take months before it is widely available.
Ryu cited statistics to illustrate in the COVID-19 resurgence throughout Geisingers service area.
During July and August there were 2,100 positive tests but more importantly, he said, the rate of positive tests averaged 3.4 percent and some weeks it was below 2 percent.
Fast forward to September and October and we have had double the number of positive tests, to almost 4,000, Ryu said. More concerning has been the increase in rate of positive tests, he said.
It has averaged 6.3 percent during those two months, he said. Over the past couple of weeks that rate has bumped above 9 percent and is quickly approaching 10 percent, he said.
By comparison, he said, during the height of the pandemic in April and May the positive test rate was in the 10 to 15 percent range.
The number of hospitalized patients has climbed into the 80s and 90s compared with the 10- to 30-range this summer, he said.
Only 15 to 20 percent of the Geisinger hospitalized patients are from nursing homes, Ryu said. That shows the virus is in the community, not just nursing homes, and why everybody needs to be careful.
Since Sept. 1, the most positive test rate has been among those in the 20 to 29 and 50 to 59 age groups, Ryu said, debunking the myth all the those with the virus are old.
The industry has learned how to treat the virus and is doing a better job managing mortality rates, he said.
But, the virus is very humbling, he said. People do get very sick, treatments are not foolproof and they dont work on everyone.
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Geisinger CEO: COVID-19 vaccine is coming but we have to be super vigilant until then - PennLive
LEXINGTON, Ky. (AP) The University of Kentucky along with two Kentucky hospitals will conduct a clinical trial for a potential COVID-19 vaccine. UK will partner with Baptist Health Lexington and Norton Healthcare in Louisville for Janssen Pharmaceutical Companies phase three clinical study. The study will evaluate Janssens COVID-19 vaccine candidate. A university press release says the clinical trial will require about 60,000 people, including significant representation from people 60 and older. The Kentucky research teams plan to enroll at least 2,000 local volunteers for the trial.
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COVID-19 vaccine trials to be run at University of Kentucky - WSIL TV
