Category: Covid-19 Vaccine

As the world waits for a COVID-19 vaccine, concerns are already rising that it may not work in obese patients, arguably one of the groups that needs it most.

More than 1 in 3 Americans is obese, and the Centers for Disease Control and Prevention has said that obese people are among the groups more likely to get sick and die of COVID-19.

"We know from other vaccines that have been tested in obese populations that these individuals don't respond as well to these vaccines," said Dr. Matthew B. Laurens, a lead investigator at the University of Maryland School of Medicine for one of the United States' most advanced coronavirus vaccine trials by Moderna Therapeutics.

Research has long shown that vaccines against viruses like influenza and hepatitis B, as well as other disease-causing organisms like tetanus and rabies, are not as effective in obese adults compared to their thinner peers.

Evidence of this phenomenon goes as far back as 1985, when hundreds of hospital employees in North Carolina were vaccinated against hepatitis B and then studied to see how their immune systems responded. Researchers found that the vaccine was twice as likely to fail -- meaning it did not provide adequate protection against hepatitis B -- in employees with a higher body mass index compared to their colleagues with lower BMIs.

In 2017, researchers at the University of North Carolina, Chapel Hill reported similar findings in patients getting their yearly flu shot. In their study of over 1,000 participants, they found that obese adults were twice as likely to develop influenza or an influenza-like illness -- despite having been vaccinated against the virus -- compared to non-obese adults.

With 42.4% of the American population being classified as obese, and research identifying obesity as a major risk factor for COVID-19 infection and severe complications from the disease, this is giving some experts reason for pause.

A woman receives a COVID-19 vaccination from nurse Jose Muniz as she takes part in a vaccine study at Research Centers of America on Aug. 7, 2020, in Hollywood, Fla.

"We recognize that while we're developing a vaccine for COVID-19, it might not work in all populations, including those who are obese. So that's a concern," said Laurens.

It's not entirely clear to experts why vaccines don't seem to work as well in obese patients, but there are a number of theories.

One thought is that the typical one-inch needle routinely used for immunizations is not long enough for use in obese adults. This is because the fat layer under the skin may be thick enough that the needle can't reach the underlying shoulder muscle, where the vaccine liquid needs to be deposited to have its best shot at working.

Another theory is that obese adults, because of their increased body mass, may actually need a bigger dose -- or even a booster dose -- of the vaccine to properly ready their immune system to fight off the virus.

A third theory has to do with how obese patients' immune systems work.

According to Dr. Leonard Friedland, the vice president and director of Scientific Affairs and Public Health for GlaxoSmithKline Vaccines, "Obesity triggers a chronic inflammatory state in humans." This constant, low-level inflammation could be what's blocking some vaccines from working as well as they do in thinner patients.

"It's a real issue," said Friedland.

But could the coronavirus vaccine be different and provide equal protection for both the obese and the non-obese?

"We don't know. I think you could say it's possible. The new technology is different," said Laurens, referring to the novel mRNA technology being used in the coronavirus vaccine trial he's currently spearheading.

An undated stock photo depicts a doctor administering a vaccination to an overweight patient.

For now, perhaps the only way to know for sure whether the vaccine will work in the obese is to include them in large phase 3 trials -- the last step before authorization from the Food and Drug Administration.

"It's important to enroll obese people, because they are likely to have associated chronic illnesses, and you really get to see if the vaccine helps those highly at-risk people," said Dr. Arthur L. Caplan, the Drs. William F. and Virginia Connolly Mitty professor of bioethics at the New York University Langone Medical Center.

Historically, obese people have been largely excluded from vaccine trials, because of these chronic illnesses, like diabetes and high blood pressure.

Coronavirus vaccine developers, however, are now attempting to combat this disparity by actively enrolling obese patients in their clinical trials.

"We think it's important to develop a vaccine that is going to work for everyone," said Laurens. "That's why we're trying to be as inclusive as possible in the phase 3 studies -- so that we can learn more about how to protect particularly the vulnerable populations, including the obese."

Nate Wood, M.D., is an internal medicine/primary care resident at Yale New Haven Hospital and a contributor to the ABC News Medical Unit.

View original post here:

COVID-19 vaccine may be less effective in obese people, experts warn - ABC News

One-third of Americans wouldnt get COVID-19 vaccine even if its free, poll says  FOX13 Memphis

Read this article:

One-third of Americans wouldnt get COVID-19 vaccine even if its free, poll says - FOX13 Memphis

HOLLYWOOD, FLORIDA - AUGUST 07: Lisa Taylor receives a COVID-19 vaccination from RN Jose Muniz as ... [+] she takes part in a vaccine study at Research Centers of America on August 07, 2020 in Hollywood, Florida. Research Centers of America is currently conducting COVID-19 vaccine trials, implemented under the federal government's Operation Warp Speed program. The center is recruiting volunteers to participate in the clinical trials, working with the Federal Government and major Pharmaceutical Companies, that are racing to develop a vaccine to potentially prevent COVID-19. (Photo by Joe Raedle/Getty Images)

As Russia debuts its new Covid-19 vaccine, Sputnik V, and begins to inoculate some of its citizens without extensive testing regarding its safety or efficacy, concern regarding the pressure to get a vaccine safely to market here in the United States via Operation Warp Speed has many people concerned, and rightfully so.

While vaccine trials typically take many years until a viable vaccine comes to market, the reality is that these are not normal times. But the process to produce a safe and effective vaccine also shouldnt be compromised. With respect to the debut of the Russian vaccine, its important not to be just first, but to be safe and effective by investing in sound Phase 3 trials. Simply put, we dont want to expose people to a vaccine until it is thoroughly tested and we have the data to support its widespread distribution. First and foremost, we do not want vaccinate children and older persons if there is any concern that it could potentially do harm.

But bringing a vaccine to market in such a short period of time requires appropriate monitoring and transparencyakin to a check and balance to maintain public confidence in the regulatory process.

One such approach is the introduction of the SAVE ActThe Safe Authorization for Vaccines during Emergencies Act. It represents bipartisan legislation that aims to improve public confidence in a potential Covid-19 vaccine by increasing the transparency of the vaccine approval process. The legislation is especially timely, as Phase 3 trials in the US began for several vaccine candidates last month.

Sponsored by U.S. Senators Maggie Hassan (D-NH), Mike Braun (R-IN), and Lisa Murkowski (R-AK), its legislative goal is to simple: increase transparency of the approval process by providing the public data and facts during the approval process itself, helping to improve confidence that Americans will accept a vaccine when it is finally approved.

As we work to get a potential vaccine approved, produced, and distributed as quickly as possible, its critically important that the public is confident that the federal government followed the necessary protocols to ensure that the vaccine is safe and effective,Senator Hassansaid in a recent press release. This bipartisan bill would ensure that key oversight mechanisms of the vaccine approval process stay in place, and that recommendations provided during this process are publicly available, even during an expedited vaccine approval process. We will push for this bills inclusion in the upcoming COVID-19 relief package.

The SAVE Act would essentially define the current operating rules and processes within the CDC and FDA for review of vaccine candidates. It would also spell out the requirements that the CDCs Advisory Committee on Immunization Practices (ACIP) and FDAs Vaccine and Related Biological Products Advisory Committee each must satisfy in order to produce recommendations regarding the safety and efficacy of vaccine candidates seeking emergency use authorization (EUA). It would also make sure that public recommendations regarding safety related to specific groups for immunization are issued by these two committees.

When a COVID-19 vaccine comes to market, Americans need to be confident it is safe and effective for their families, saidSenator Braun. The SAVE Act makes the vaccine approval process transparent so Americans can see CDCs and FDAs rigorous review process for themselves as a vaccine gets closer to market.

This bill makes sure that federal regulators do their part to ensure that a safe and effective vaccine will be deployed to the public in a timely manner.It also ensures that the regulatory approval process for any potential COVID-19 vaccine is efficientand not slowed down by regulatory hurdles that have nothing to do with safety and effectiveness, added Senator Braun.

Senator Murkowski emphasized that my focus right now is providing all Americans with the resources and support they need to address the impacts of the COVID-19 pandemic, including supporting efforts to help develop a vaccine. Equally important, is that a vaccine is safe and effective, and that people trust it.

Our bill works to ensure that the vaccine approval process is clear and transparent, giving Americans the confidence they will need in making decisions once we have a successful vaccine, she added.

While its important to understand that such bipartisan legislation would not compromise the speed of the current vaccine approval process, it would guarantee that transparent committee meetings occurbut if they dont for some reasonthe Secretary of Health and Human Services (HHS) would be required to provide and explanation for such a decision.

Senator Hassan has made it a priority to push for funding and safety measures in the ramp up to a potential vaccine candidate. Along with 27 other colleagues, last month she called for Congress to provide at least 5.6 billion dollars in federal funding to support and develop Covid-19 vaccine infrastructure. In early May, during a Senate Health, Education, Labor, and Pensions Committee hearing, Senator Hassan asked Dr. Anthony Fauci what is necessary to mass produce and distribute a Covid-19 vaccine candidate. In early April, she also called on the Trump administration to look into concerns related to domestic supply chain for hypodermic needles and syringes necessary to administer a potential Covid-19 vaccine.

Gaining the confidence of the public in a potential COVID-19 vaccine is mission critical if we want to ensure a high rate of vaccination; yet currently, many Americans are unsure if they are willing to get it if one becomes available. Its clear to me that ensuring proper review of data will help ensure that any vaccine that enters the market is safe and effective, and will also lead to a higher level of public confidence in the vaccine, said Dr. Joseph Sakran, Director of Emergency General Surgery at Johns Hopkins Hospital.

Senator Hassans bipartisan bill allows for emergency authorization of vaccine products while combining someofcornerstone pieces that exist during normal licensure.This will also allow healthcare workers to instill the necessary confidence patients often need when they look to us for advice, added Sakran.

William A. Haseltine, PhD, Chair and President, ACCESS Health International and a Forbes Healthcare contributor, explained that legislation is required to assure that any Covid-19 vaccine approved for use in the United States, including emergency use authorization, meet the FDA requirements for a vaccine to be used for young children, and older adults. Otherwise, vaccines of unknown safety and efficacy may be approved for political, electoral, or economic reasons independent of either their known safety and efficacy.

While the technology behind Sputnik V is reported to resemble Astra Zenecas vaccine candidate,using human adenovirus vectors as opposed to Astras monkey vectorslack of effective testing of this vaccine may result in compromised safety and efficacy when administered to large groups. Whats clear is: if issues develop related to lack of efficacy or safety of this vaccine, it could undermine public confidence in Operation Warp Speeds vaccine candidate and other vaccines, resulting in further vaccine hesitancy. In effect, failure of Sputnik V could poison the entire field of vaccine candidates.

Regarding the new Sputnik V vaccine, do its benefits outweigh its risks? At this time, we dont know exactly how many people in Russia received it so far, but Russian elites or military involved in earlier trials are most likely the recipients of the new vaccine. The Russians, and their partners in Saudi Arabia and the United Arab Emirates (UAE), plan to produce 500 million doses of their vaccine, as they conduct essentially live Phase 3 trials on their vaccine, according to a report today by NBC News. Its also vital to understand that a targeted global distribution of the vaccine could impact the Russians sphere of influence, which could certainly affect or change the optics of the upcoming election in November.

Full coverage and live updates on the Coronavirus

Original post:

Worried About The Safety And Effectiveness Of The Covid-19 Vaccine? The SAVE Act Aims To Make Transparency A Priority - Forbes

Tuesday, August 11, 2020 8:37 a.m. EDT by Thomson Reuters

(Reuters) - Arcturus Therapeutics Holdings Inc said on Tuesday the first group of participants had been dosed in an early-stage trial testing its COVID-19 vaccine candidate and that results from the trial were expected in the fourth quarter.

Shares of the San Diego, California-based company rose about 4% in trading before the bell.

The company is among several drugmakers racing to develop a safe and effective vaccine for the new coronavirus that has killed more than 735,000 people globally.

Arcturus in April said preclinical data testing its experimental vaccine, ARCT-021, which is being developed jointly with Singapore's Duke-NUS Medical School, showed the vaccine candidate could trigger an immune response to the virus.

"Based on preclinical immunogenicity data, our self-replicating mRNA-based investigational vaccine could have a highly differentiated safety and efficacy profile, and may potentially allow vaccination at very low doses, and with a single administration," Arcturus Chief Executive Officer Joseph Payne said in a statement.

The current trial includes two parts that will assess ARCT-021's dosing, safety and effectiveness in participants including older adults aged between 56 and 80 years.

ARCT-021, like Moderna Inc's COVID-19 vaccine candidate, uses mRNA, or messenger RNA, to inoculate against the coronavirus.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D'Silva)

Read more:

Arcturus Therapeutics begins human trials of potential COVID-19 vaccine - WHTC News

The U.S. government is pouring billions into COVID-19 vaccines, and candidates from three companies are moving along quickly: Moderna, Pfizer and Novavax.Here's what you need to know about them.These are among the dozens of COVID-19 vaccines in trials around the world as researchers rush to find a way to stop the pandemic.To help speed the process, the U.S. government's Operation Warp Speed is providing some funding for those three and five others vaccine candidates the Department of Health and Human Services calls "the most promising."Operation Warp Speed's goal is to have 300 million doses of a vaccine that's safe and effective by January 2021.While the Phase 1 trial results are promising, the proof will be in the results of the final, large Phase 3 trials. If a vaccine candidate makes it through that, it will go to the Food and Drug Administration for approval.Phase 1 trials involve testing the vaccine in a small group of people to see whether it's safe and whether it's effective. Phase 2 trials involve a larger group and often involve various potential doses. Phase 3 trials are a final stage before seeking approval and look for safety, efficacy and optimal dosing. For coronavirus, they are all scheduled to involve 30,000 people.President Donald Trump said last week he's optimistic that a vaccine will be available by the presidential election Nov. 3. Experts told CNN, though, that it's highly unlikely that either of the two U.S. companies with a vaccine candidate now in Phase 3 trials will have a vaccine ready for use by then, given the status and timelines of their trials now.ModernaWhere is it now? The start of Moderna's Phase 3 trial of its mRNA-1273 vaccine was announced just last week. It will involve 30,000 adults at 89 clinical research sites around the country. It is the first Phase 3 trial begun under Operation Warp Speed, according to the National Institutes of Health.Phase 2 started in May.Trial results: So far, only Phase 1 results have been released. Those early results showed the vaccine brought about an immune response, which is what researchers wanted to see. The higher the dose, the higher the immune response was in the people who got it.How safe is it? More than half of participants had side effects, including fatigue, chills, headache, muscle pain and pain at the injection site. These are considered normal side effects for a vaccine. The higher the dose, the worse the side effects. The Phase 3 trial will use the middle dose.Who is developing it? Moderna, a biotech based in Cambridge, Massachusetts, developed the vaccine with help from the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health.PfizerWhere is it now? Pfizer has more than one vaccine candidate, being developed together with the German company BioNTech. It has moved into a combined Phase 2/3 trial, also started last week, with one of them, BNT162b2. That's being carried out at about 120 sites worldwide, including 39 U.S. states and Argentina, Brazil and Germany.When will we have it? If the trial is successful, Pfizer and BioNTech have said they are on track to seek regulatory review as early as October. If it gets emergency authorization from the FDA, as many as 100 million doses may be available by the end of the year, and about 1.3 billion by the end of 2021.The Department of Health and Human Services and Department of Defense last month announced a $1.95 billion agreement with Pfizer to produce 100 million doses of the vaccine. The deal also allows the U.S. government to acquire an additional 500 million doses.Trial results: In the combined Phase 1/2 trial, both vaccines brought about an immune response and produced antibodies, a "double-arm" approach that the companies hope will be more effective and provide longer protection. So far, only one has moved on to more advanced trials. Almost 120 people participated.How safe is it? Preliminary data from the Phase 1/2 trial showed "a favorable overall tolerability profile" for the vaccine, Pfizer said in a news release, "with generally mild to moderate" side effects that lasted one to two days, "such as fever, fatigue and chills and no serious adverse events."NovavaxWhere is it now? Maryland-based biotech Novavax hopes to have its vaccine in Phase 3 trials next month.Trial results: Novavax released data from its Phase 1 trial Tuesday involving 131 participants. After two doses of the vaccine, participants had levels of antibodies that can fight off the virus that were four times higher, on average, than those developed by people who have recovered from COVID-19.The vaccine also brought about a response by immune cells, according to an analysis of 16 randomly selected volunteers.How safe is it? Of the 106 people who got the vaccine, and not a placebo, five had severe side effects, including muscle pain, nausea and joint pain, and one had a mild fever. The side effects lasted two days or less, on average.

The U.S. government is pouring billions into COVID-19 vaccines, and candidates from three companies are moving along quickly: Moderna, Pfizer and Novavax.

Here's what you need to know about them.

These are among the dozens of COVID-19 vaccines in trials around the world as researchers rush to find a way to stop the pandemic.

To help speed the process, the U.S. government's Operation Warp Speed is providing some funding for those three and five others vaccine candidates the Department of Health and Human Services calls "the most promising."

Operation Warp Speed's goal is to have 300 million doses of a vaccine that's safe and effective by January 2021.

While the Phase 1 trial results are promising, the proof will be in the results of the final, large Phase 3 trials. If a vaccine candidate makes it through that, it will go to the Food and Drug Administration for approval.

Phase 1 trials involve testing the vaccine in a small group of people to see whether it's safe and whether it's effective. Phase 2 trials involve a larger group and often involve various potential doses. Phase 3 trials are a final stage before seeking approval and look for safety, efficacy and optimal dosing. For coronavirus, they are all scheduled to involve 30,000 people.

President Donald Trump said last week he's optimistic that a vaccine will be available by the presidential election Nov. 3. Experts told CNN, though, that it's highly unlikely that either of the two U.S. companies with a vaccine candidate now in Phase 3 trials will have a vaccine ready for use by then, given the status and timelines of their trials now.

Where is it now? The start of Moderna's Phase 3 trial of its mRNA-1273 vaccine was announced just last week. It will involve 30,000 adults at 89 clinical research sites around the country. It is the first Phase 3 trial begun under Operation Warp Speed, according to the National Institutes of Health.

Phase 2 started in May.

Trial results: So far, only Phase 1 results have been released. Those early results showed the vaccine brought about an immune response, which is what researchers wanted to see. The higher the dose, the higher the immune response was in the people who got it.

How safe is it? More than half of participants had side effects, including fatigue, chills, headache, muscle pain and pain at the injection site. These are considered normal side effects for a vaccine. The higher the dose, the worse the side effects. The Phase 3 trial will use the middle dose.

Who is developing it? Moderna, a biotech based in Cambridge, Massachusetts, developed the vaccine with help from the National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health.

Where is it now? Pfizer has more than one vaccine candidate, being developed together with the German company BioNTech. It has moved into a combined Phase 2/3 trial, also started last week, with one of them, BNT162b2. That's being carried out at about 120 sites worldwide, including 39 U.S. states and Argentina, Brazil and Germany.

When will we have it? If the trial is successful, Pfizer and BioNTech have said they are on track to seek regulatory review as early as October. If it gets emergency authorization from the FDA, as many as 100 million doses may be available by the end of the year, and about 1.3 billion by the end of 2021.

The Department of Health and Human Services and Department of Defense last month announced a $1.95 billion agreement with Pfizer to produce 100 million doses of the vaccine. The deal also allows the U.S. government to acquire an additional 500 million doses.

Trial results: In the combined Phase 1/2 trial, both vaccines brought about an immune response and produced antibodies, a "double-arm" approach that the companies hope will be more effective and provide longer protection. So far, only one has moved on to more advanced trials. Almost 120 people participated.

How safe is it? Preliminary data from the Phase 1/2 trial showed "a favorable overall tolerability profile" for the vaccine, Pfizer said in a news release, "with generally mild to moderate" side effects that lasted one to two days, "such as fever, fatigue and chills and no serious adverse events."

Where is it now? Maryland-based biotech Novavax hopes to have its vaccine in Phase 3 trials next month.

Trial results: Novavax released data from its Phase 1 trial Tuesday involving 131 participants. After two doses of the vaccine, participants had levels of antibodies that can fight off the virus that were four times higher, on average, than those developed by people who have recovered from COVID-19.

The vaccine also brought about a response by immune cells, according to an analysis of 16 randomly selected volunteers.

How safe is it? Of the 106 people who got the vaccine, and not a placebo, five had severe side effects, including muscle pain, nausea and joint pain, and one had a mild fever. The side effects lasted two days or less, on average.

See the rest here:

These 3 COVID-19 vaccines have been in the news. Here's what you need to know about them - WXII The Triad

MOSCOWRussia registered the worlds first Covid-19 vaccine, President Vladimir Putin said, marking a milestone in the fight against the new coronavirus but amid safety concerns in the West over the countrys accelerated clinical evaluations.

Tuesdays development was met with anticipation and skepticism in the country and raises questions not only about the efficacy of the Russian vaccine, which some global health officials say was developed by cutting regulatory corners, but also how the registration could alter the landscape...

View original post here:

Russia Registers Worlds First Covid-19 Vaccine Despite Safety Concerns - The Wall Street Journal

BioNTech execs say theyre on track to get their late-stage data on a Covid-19 vaccine partnered with Pfizer into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they wont be wasting any time in hustling that over to the FDA.

I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful, said Ugur Sahin, BioNTechs CEO and co-founder.

Unlock this story instantly and join 87,100+ biopharma pros reading Endpoints daily and it's free.

SUBSCRIBE SIGN IN

Continue reading here:

ranks all 28 players in the Covid-19 vaccine race. Here's how it stacks up today Endpoints News - Endpoints News

FILE PHOTO: U.S. President Donald Trump speaks during a coronavirus disease (COVID-19) pandemic briefing at the White House in Washington, U.S., August 10, 2020. REUTERS/Kevin Lamarque

WASHINGTON (Reuters) - U.S. President Donald Trump will be briefed on U.S. COVID-19 vaccine efforts later on Tuesday and will likely give a public update, White House Adviser Kellyanne Conway said, after Russia announced it had approved a vaccine for the novel coronavirus.

The president is getting a vaccine update here at the White House today, and Im sure he will announce that in an open press event and also probably his press briefing later today, Conway told Fox News interview.

(Story refiles to correct spelling in paragraph 1 to Conway, not Conaway)

Reporting by Lisa Lambert and Susan Heavey; Editing by Catherine Evans

Link:

Trump expected to give update on U.S. COVID-19 vaccine development -White House - Reuters

As investors carefully scan an uncertain horizon, one thing is clear: The backdrop for markets will look very different in three months time.

In a note to clients this week, Goldman Sachs strategists including Kamakshya Trivedi predicted a substantially different landscape by December.

They pointed to three potential developments:

On reopening schools, Goldman Sachs expects a bumpy process characterized by some false starts, especially in the United States. That could hang over markets, particularly in September.

The evidence so far suggests that there is a path to reopening schools without prompting a sharp increase in virus spread, the investment bank said. But those examples have generally been in places where transmission has been very low and where strict protocols have been followed.

The passage of the US election will also provide investors with greater clarity, particularly regarding the relationship with China. Goldman Sachs thinks that decoupling between the worlds two biggest economies is poised to continue no matter who wins, though Joe Biden would be less likely to employ tariffs.

Most importantly, Goldman Sachs thinks theres a good chance that at least one vaccine will be approved by the US Food and Drug Administration by the end of November, allowing it to be broadly distributed by mid-2021.

This kind of timeline could see a substantial boost to GDP relative to a no-vaccine case, particularly for the US, which is likely to lead the vaccine race and is likely to experience worse outcomes than in Europe without a vaccine, the banks strategists said.

They predict the S&P 500 will end the year around current levels, but see the potential for the index to shoot up another 11% if a viable vaccine comes into play.

What it means: The picture for investors is murky this summer, with little transparency on the path of the virus or upcoming rounds of stimulus spending. But Wall Street thinks some clouds could clear before year-end.

Were at a crossroads, Thomas Lee, cofounder of Fundstrat Global Advisors told my CNN Business colleague Alison Kosik on Wednesday.

If it becomes evident that the virus has peaked in the United States and the surge of cases in the Sun Belt has been brought under control, investors should go on the offensive, he said.

Of course, nothing is a given. In three months, the situation also could look materially worse, with cases rising in new parts of the United States. There are also growing concerns about a second wave hitting Europe and Asia.

See the original post here:

What's on Wall Street horizon? Schools, elections, COVID-19 vaccine to affect landscape 'substantially' - WRAL Tech Wire

Russian President Vladimir Putin is shown in a file photo. (Photo by Mikhail Svetlov/Getty Images)

MOSCOW (AP) -- Russia on Tuesday became the first country to clear a coronavirus vaccine and declare it ready for use, despite international skepticism. President Vladimir Putin said that one of his daughters has already been inoculated.

Putin emphasized that the vaccine underwent the necessary tests and has proven efficient, offering a lasting immunity from the coronavirus. However, scientists at home and abroad have been sounding the alarm that the rush to start using the vaccine before Phase 3 trials -- which normally last for months and involve thousands of people -- could backfire.

Speaking at a government meeting Tuesday, Putin said that the vaccine has undergone proper testing and is safe.

"I know it has proven efficient and forms a stable immunity, and I would like to repeat that it has passed all the necessary tests," he said. "We must be grateful to those who made that first step very important for our country and the entire world."

The Russian leader added that one of his two adult daughters has received two shots of the vaccine. "She has taken part in the experiment," Putin said.

Putin said that his daughter had a temperature of 38 degrees Celsius (100.4 Fahrenheit) on the day of the first vaccine injection, and then it dropped to just over 37 degrees (98.6 Fahrenheit) on the following day. After the second shot she again had a slight increase in temperature, but then it was all over.

"She's feeling well and has high number of antibodies," Putin added. He didn't specify which of his two daughters -- Maria or Katerina -- received the vaccine.

The Health Ministry said in Tuesday's statement that the vaccine is expected to provide immunity from the coronavirus for up to two years.

Putin emphasized that vaccination will be voluntary.

Russian authorities have said that medical workers, teachers and other risk groups will be the first to be inoculated. Deputy Prime Minister Tatyana Golikova said that the vaccination of doctors could start as early as this month.

Professor Alexander Gintsburg, head of the Gamaleya Institute that developed the vaccine, said that vaccination will start while the Phase 3 trials continue. He said that initially there will be only enough doses to conduct vaccination in 10-15 of Russia's 85 regions, according to the Interfax news agency.

Russian officials have said that large-scale production of the vaccine will start in September, and mass vaccination may begin as early as October.

Russia has registered 897,599 coronavirus cases, including 15,131 deaths.

When the pandemic struck Russia, Putin ordered state officials to shorten the time of clinical trials for potential coronavirus vaccines.

Becoming the first country in the world to develop a vaccine was a matter of national prestige for the Kremlin as it tries to assert the image of Russia as a global power. State television stations and other media have praised scientists working on it and presented the work as the envy of other nations.

Gintsburg raised eyebrows in May when he said that he and other researchers tried the vaccine on themselves.

Human studies started June 17 among 76 volunteers. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder. Some in the first half were recruited from the military, which raised concerns that servicemen may have been pressured to participate.

Amid Russia's rush to become the first to create a vaccine, the U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs.

As the trials were declared completed, questions arose about the vaccine's safety and effectiveness. Some experts scoffed at Russian authorities' assurances that the vaccine drug produced the desired immune response and caused no significant side effects, pointing out that such claims need to be backed by published scientific data.

The World Health Organization said all vaccine candidates should go through full stages of testing before being rolled out. Experts have warned that vaccines that are not properly tested can cause harm in many ways -- from a negative impact on health to creating a false sense of security or undermining trust in vaccinations.

Read more from the original source:

Russia announces it has registered a COVID-19 vaccine - KTVU San Francisco