Category: Covid-19

HUNTSVILLE, Ala (WHNT) Alabama health officials say COVID-19 is starting to surge once again in the state.

For example, Huntsville Hospital reported this week that its COVID-19 patient volume is at 95 patients systemwide and since July 4, the Alabama Department of Public Health (ADPH) has been reporting a 27% increase in COVID positivity rate.

ADPH warns that as the positive COVID numbers continue to rise due to subvariants to contend with.

According to infectious disease experts, Madison County has only 35% of the countys population fully vaccinated. The problem is that it doesnt change the current state of the pandemic in north Alabama.

That means Alabamais still not out of the wood just yet.

The state has seen a 67% increase in its COVIDpositivity rate over the past 30 days and thats not counting the unreported cases over the holiday weekend.

Thats because new subvariants have appeared and as Dr. Wes Stubblefield of theADPHnotes, the variants have had a unique ability to evade immunity protections.

Most of us out there have either had the vaccine or had the infection or have had both but that doesnt mean you cant get it again, Stubblefield told News 19. The immunity runs and it doesnt matter where it comes from. Vaccination produces more consistent immunity and obviously, antibodies produce immunity but neither one lasts long-term.

Stubblefield added that they were seeing about 100 cases a day during the springmonths. Now there are reports of just under 2,000 cases per day.

30 states reported more cases in the week of June 28 to July 5 than in the week before, according to an analysis by John Hopkins University.

COVID is still real and its still worse than the flu on average, Stubblefield noted. Most healthy people that fall into those high-risk conditions have a serious risk of going into the hospital and being very sick.Thats why we want people to be vaccinated and why we want them to know that there are therapies for people who get COVID and how to get to those therapies.

Alabama continues to rank near the bottom of the country in total COVID vaccinations.

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Contagious Omicron subvariants behind the latest COVID-19 surge in Alabama - WHNT News 19

Early diagnosis of COVID-19 is essential to prevent further infections and the degradation to severe disease. Reverse transcriptase-polymerase chain reaction (RT-PCR) tests are the standard COVID-19 diagnostic, but the relatively long turnaround time for the lab assay may hinder timely quarantine and containment of the virus.

Rapid antigen tests (RATs) have recently become more prevalent, and can be performed by individuals from the safety of their own homes. However, the rise of the highly infectious and evasive Omicron and its subvariants have called into question the accuracy of RATs.

One study, published in JAMA, evaluated the comparative abilities of RT-PCR and RATs to detect the Omicron variant. The study population included Stanford University student athletes, all of whom had no history of COVID-19 infection in the last 90 days. The students were between 17-23 years of age and 52.0% female. Approximately 98% of all students had received 2 doses of the Pfizer-BioNTech or Moderna COVID-19 vaccines, or 1 dose of Johnson & Johnson.

The students all self-administered a RAT between January 1-11, 2022. The symptomatic students with a positive RAT were isolated without a confirmatory RT-PCR test. The students who were asymptomatic with a positive RAT received subsequent RT-PCR testing.

The investigators performed statistical analysis with Prism version 9.0 to visualize the data, and Mann-Whitney U tests for median cycle threshold value comparison.

Of the 723 students included in the study, 46 (6.4%) had a positive RAT, of whom 35 (76.1%) were symptomatic. A total of 12 of the 35 symptomatic participants receives a positive RT-PCR result within 24 hours, while the remaining 23 students were assumed to be positive.

The study also examined COVID-19 infections missed by the RATs; 27 participants had a negative RAT followed by a positive RT-PCR, meaning there were 73 diagnosed COVID-19 cases in the cohort, for an infection rate of 10.1%.

The overall sensitivity of the rapid antigen tests was determined to be 63.0%, with a specificity of 99.8%. The RATs were overall very specific, with only 1 false positive in the cohort. This suggests that a positive RAT is reliable and does not require RT-PCR confirmation. Among the symptomatic participants, RATs had a sensitivity of 77.8%, but this dropped to 39.2% in asymptomatic patients.

The better performance of RATs in symptomatic individuals is believed to be due to the difference in cycle threshold values, which have been shown to correlate to RAT sensitivity in lab and clinical studies. The 23 students who tested positive with both the RAT and RT-PCR had lower cycle thresholds, averaging 24.6. The 27 students who were RAT-negative and PCR-positive had an average cycle threshold of 35.0. Among the RT-PCR-positive cohort, the 22 symptomatic persons had a median cycle threshold of 24.7, while the asymptomatic students averaged 33.6.

Viral sequencing determined the Omicron variant was responsible for 44 of the 46 positive cases (95.7%). The investigators concluded, Rapid antigen testing performed similarly in the detection of the Omicron variant compared with previous variants, with high specificity but poor sensitivity, particularly among asymptomatic individuals.

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Comparing the Accuracy of COVID-19 Tests During Omicron - Contagionlive.com

Effectiveness of vaccination mandates in improving uptake of COVID-19 vaccines in the USA  The Lancet

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Effectiveness of vaccination mandates in improving uptake of COVID-19 vaccines in the USA - The Lancet

Will decreases in Covid-19 testing locations impair the ability to monitor new Covid-19 coronavirus ... [+] variants such as the BA.2.75 Omicron subvariant, which has been dubbed the Centaurus variant? (Photo by Wang Ying/Xinhua via Getty Images)

While it aint the Centaurus of Covid-19 attention right now, the new BA.2.75 Omicron subvariant does deserve to be closely monitored. This so-called Centaurus subvariant, first detected in India, has now appeared in at least 10 other countries including the U.S. And there are eight-not-so-simple reasons why the BA.2.75 could potentially be even more concerning than the already concerning BA.5 subvariant of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Before you run around the room flapping your arms in a panic, though, the emphasis here is on the word potentially as opposed to definitely or fer sure. Plus, public health authorities will never say, OK, everyone, time to panic now.

Speaking of public health authorities, guess whos now monitoring the BA.2.75? The World Health Organization, thats who. If you look at the World Health Organizations (WHOs) Tracking SARS-CoV-2 variants website, youll now find the BA.2.75 categorized as a VOC-LUM. What the VOC is a VOC-LUM? Well, it stands for Variants of Concern (VOC) Lineage Under Monitoring (LUM), which basically means that these are offshoots of variants that have already been deemed VOCs and deserve to be closely watched. The list of VOC-LUMs currently includes several sub-lineages of the BA.2 Omicron subvariant (that is, the BA.2.12.1, BA.2.9.1, BA.2.11, BA.2.13, and BA.2.75) along with two sister lineages of the BA.1 and BA.2 Omicron subvariants (consisting of the BA.4 and BA.5).

The BA.4 and BA.5 have already proven to be twisted sister lineages, so to speak. During a July 6 media briefing, the WHO Director-General Tedros Adhanom Ghebreyesus, PhD, mentioned that, On Covid-19, globally reported cases have increased nearly 30% over the past two weeks. Four out of six of the WHO sub-regions saw cases increase in the last week. Clearly, this goes against the Covid is over narrative that some have been trying to unjustifiably spread. The WHO Director-General then specified that In Europe and America, BA.4 and BA.5 are driving waves, before mentioning the Centaurus: In countries like India a new sub lineage of BA.2.75 has also been detected, which were following.

On July 6, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said, In ... [+] countries like India a new sub lineage of BA.2.75 has also been detected, which were following. (Photo by FABRICE COFFRINI/AFP via Getty Images)

The BA.4 and BA.5 have been essentially making waves in part because theyve proven more transmissible than previous versions of the virus. However, there may be another inescapable reason for their Covid-19 surge production role: immune escape. Immune escape may sound like a ride in a bad amusement park, but it represents what happens when a virus has accumulated enough mutations to look different enough to avoid any existing immune protection. This would be akin to your high school classmate getting so much plastic surgery or such an extreme makeover that you end up asking him or her during a reunion, hi, have we met before? Essentially, mutations may have made the BA.5 so different from the original SARS-CoV-2 and other earlier versions like the Alpha, Beta, and Delta variants that immune protection you may already have from either vaccination or previous infection may not be able to adequately recognize and protect against the BA.5.

This greater transmissibility and immune escape potential are what prompted Eric Topol, MD, founder and director of the Scripps Research Translational Institute, to call the BA.5 the worst version of the virus that weve seen. As I wrote for Forbes on Sunday, such a description is sort of like calling Transformers: The Last Knight the worst of the Transformers movies. When something is the worst of the bad, it certainly isnt good news.

Ah, but, if BA.5 already looks very different from earlier versions of the virus like the BA.1 and BA.2 Omicron subvariants, the Centaurus subvariant takes the whole makeover thing eight steps further. Its not clear who came up with the nickname Centaurus, which presumably is an extension of the word centaur. A centaur is a creature thats half human and half horse. Its a mythical creature in case you are wondering whether this description matches that of your boss. Nevertheless, such a moniker could potentially apply to something that looks quite different from anything that youve seen before. The following tweet from Topol pointed to just how different the BA.2.75 looks compared to the BA.5:

Topol included a tweet thread from Ulrich Elling, PhD, a researcher at the Institute of Molecular Biotechnology in Vienna, Austria. This tweet thread illustrated which parts of the BA.2.75 viruss spike protein are affected by these mutations. Note that the areas affected include the receptor-binding portion, that is the part of the spike protein that first docks with your cells sort of like how your hands grab a refrigerator door handle before you try to get inside. In his tweet thread, Elling stated that The number of 8 additional mutations in BA.2.75 is remarkable, Delta had 8 in spike in total. 3 mutations can make a huge difference (BA.5). Thus the 11 Mutations distinct between BA.5 and BA.2.75 could allow for yet another wave as BA.5 immunity might not protect, as you can see here:

As seen above, Elling described his thread as HIGHLY SPECULTIVE in ALL CAPS. It would be considered highly speculative as well since more data and info are needed before anyone can make more definitive conclusions about how much of a threat BA.2.75 may turn out to be. Just because the BA.2.75 is different doesnt mean that it will become a major problem. In order to overtake other versions of the virus, the BA.2.75 needs to be more fit than the BA.5 and other variants in some way. In this case, being more fit doesnt mean able to do more push-ups on its little spikes. It means being able to survive and spread more readily than other circulating variants.

Is the BA.2.75 actually more transmissible than other variants and subvariants? In the words of Carly Rae Jepsen, call it maybe. There have been some suggestions that this might be the case. For example, Mike Honey, founder of Manga Solutions a data visualization company in Melbourne, Australia, posted the following graph showing how the detection of BA.2.75 has increased in India, where this subvariant was first detected:

Before you say, oh, Honey about this rise, take such information with a fanny pack of salt for now until more data and studies emerge to more accurately determine the BA.2.75s transmissibility. Sure, the BA.2.75 has already appeared in at least 10 other countries including Australia, Canada, Germany, New Zealand, the U.K., and the U.S. But for it to keep spreading, it will have to overtake the BA.5. And thats not going to be easy. The BA.5 is the current dominant, alpha-dog version of the virus in many countries including the U.S, where it now comprises an estimated 53.6% of reported Covid-19 cases, according to the Centers of Disease Control and Prevention (CDC).

Its also not yet clear whether the BA.2.75 may cause worse Covid-19, as Soumya Swaminathan, MD, Chief Scientist for the WHO, emphasized in the video accompanying the following tweet:

Again, about the BA.2.75 much to learn we have, as Yoda might say. So dont jump to conclusions yet about what this subvariant may end up doing. On one end of the spectrum, the BA.2.75 could go the way of many reality TV show characters, making a little bit of news momentarily before fading back into obscurity. On the other end of the spectrum, the bad end, this variant could eventually displace others as the new alpha-dog of variants and fuel additional surges. Then there are a bunch of different possible scenarios that fall between these two extremes. Predicting what will happen to a subvariant so early on and what other competing subvariants may emerge can be like trying to predict what fashion trends will take hold. Heck who predicted that knitted crop tops, sagging pants, and way-too-ripped jeans would become popular before they actually did?

Regardless, the emergence of the BA.2.75 shouldnt change what you should already be doing, with an emphasis on the word should. Its another reminder that the Covid-19 pandemic is definitely not over and that Covid-19 precautions are still needed, despite what some people, politicians, your Uncle Fred, that person at the smoothie bar, or those anonymous social media accounts may try to tell you. While the new BA.2.75 may or may not become the Centaurus of Covid-19 attention in the coming weeks or months, the key is to stop the horse (or half horse) before it has left the barn and prevent Covid-19 surges before they occur.

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New BA.2.75 Omicron Subvariant: Heres The Centaurus Covid-19 Coronavirus - Forbes

CLEVELAND, Ohio The FDA says pharmacists can prescribe Pfizers antiviral therapy paxlovid, COVID-19 is now the third-leading cause of death behind heart disease and cancer, repeated COVID-19 infection increases risk of complications, and a new vaccine may protect against future coronavirus variants.

Cleveland.com has the latest coronavirus research for Friday July 8, 2022.

Pharmacists allowed to prescribe COVID-19 treatment Paxlovid, says FDA

The U.S. Food and Drug Administration will now allow pharmacists to prescribe the drug Paxlovid to eligible patients with COVID-19. Previously the drug could only be obtained with a doctors prescription. However, the FDA revised its usage authorization this week as a way provide patients with easier access.

The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic, Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,said Dr. Patrizia Cavazzoni, director for the FDAs Center for Drug Evaluation and Research.

COVID-19 third leading cause of death in the United States

An analysis of national death certificate data by researchers at the National Cancer Institute shows that COVID-19 was the third-leading cause of death in the United States from March 2020 to October 2021, accounting for 1-in-8 deaths.

Heart disease was the No. 1 cause of death, followed by cancer. Accidents and stroke were the fourth and fifth leading causes of death. In every age group 15 years and older, COVID-19 was one of the top five causes of death.

The study appeared July 5 in JAMA Internal Medicine.

When data from 2020 and 2021 were analyzed separately for different age groups, the researchers found that the likelihood of death from COVID-19 increased in those aged 35-44 and 45-54 from the the fourth- and fifth-leading cause of death to the first- and second-leading cause of death. Among those 85 and older, COVID-19 was the second-leading cause of death in 2020, but dropped to third in 2021, likely because of targeted vaccination efforts in this age group, the researchers postulate.

Other causes of death, including heart disease, accidents, stroke, Alzheimers disease, and diabetes increased from 2019 to 2020, possibly because people were reluctant to seek medical care for fear of catching COVID-19.

The authors said that additional impacts of the pandemic on other causes of death may emerge in the years to come, such as increased cancer diagnoses or deaths because the pandemic prevented many people from getting the necessary screenings.

Complication risks increase with COVID-19 reinfection

Its increasingly common to become infected with COVID-19 more than once. And some early research suggests that individuals may become sicker with each subsequent reinfection.

The research examined the medical records from more than 5 million American veterans. What they found was that each subsequent reinfection came with increased risks.

The risk of cardiovascular disorders, problems with blood-clotting, diabetes, fatigue, gastrointestinal and kidney disorders, mental health problems, musculoskeletal disorders and neurologic damage all increased with reinfection. For example, the likelihood of heart and clotting problems, fatigue and lung damage roughly doubled each time you catch COVID.

The study, which has not yet been published, is under review by the journal Nature.

Its still unclear say the authors, whether the effects are real or coincidental. Many of the patients who experienced multiple COVID-19 infections were also older, and had more pre-existing health conditions to start.

Vaccine Could Protect Against Future Covid-19 Variants

A team of scientists from Caltech say they have developed a new type of vaccine that is capable of detecting a wide variety of betacoronaviruses, including those that cause COVID-19. The vaccine, called Mosaic-8 is a hybrid of a nanoparticle joined to spike proteins from the SARS CoV2 virus, as well as seven other proteins from betacoronaviruses.

Animals vaccinated with the mosaic-8 nanoparticles elicited antibodies that recognized virtually every SARS-like betacoronavirus strain we evaluated, says Alexander Cohen, Caltech post-doc and co-first author on the new study. Some of these viruses could be related to the strain that causes the next SARS-like betacoronavirus outbreak, so what we really want would be something that targets this entre group of viruses. We believe we have that.

The research appears in the journal Science on July 5.

Small NIH study reveals how immune response triggered by COVID-19 may damage the brain

A study from the National Institutes of Health describes the immune response triggered by COVID-19 infection that damages the brains blood vessels and may lead to short- and long-term neurological symptoms.

The scientists examined brain changes in nine people who died suddenly after contracting the virus and observed the presence of immune complexes molecules formed when antibodies bind to foreign substances on the surface of cells lining the blood vessels in the brains of COVID-19 patients.

The scientists believe that antibodies, produced in response to COVID-19, may mistakenly target cells crucial to the blood-brain barrier forming the immune complexes, which in turn leads to inflammation and tissue damage.

Tightly packed endothelial cells help form the blood-brain barrier, which keeps harmful substances from reaching the brain while allowing necessary substances to pass through. Damage to endothelial cells in blood vessels in the brain can lead to leakage of proteins from the blood. This causes bleeds and clots in some COVID-19 patients and can increase the risk of stroke.

The study was published in the journal Brain.

Understanding how SARS-CoV-2 can trigger brain damage may help inform development of therapies for COVID-19 patients who have lingering neurological symptoms, the authors say.

It is quite possible that this same immune response persists in Long COVID patients resulting in neuronal injury, said Dr. Avindra Nath, the studys lead author. There could be a small indolent immune response that is continuing, which means that immune-modulating therapies might help these patients. So these findings have very important therapeutic implications.

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Pharmacists can prescribe Pfizers antiviral therapy paxlovid; COVID-19 ranks behind only heart disease, canc - cleveland.com

The smartphone app that allows people to self-report COVID-19 infections and then alerts other app users who may have been exposed will stop operating on July 27.

The state health department says COVID Alert PA, in use since early in the pandemic, is no longer an essential tool, even though the threat isnt over.

As we move forward through this phase of the response, the COVID Alert PA app is no longer critical regardless of the current volume of COVID-19 cases. The department will continue to stay alert and monitor COVID-19 cases, health department spokeswoman Maggi Barton said.

As of Wednesday, Pennsylvania had seven-day averages of 1,979 new cases and nine deaths per day, with 45,821 COVID-19 deaths since the start of the pandemic. Slightly less than 1,100 people were hospitalized with COVID-19 as of Wednesday, including 99 in intensive care and 45 on breathing ventilators.

The app was downloaded by about 1.2 million people.

Barton said 4,853 people who tested positive for COVID-19 uploaded their result to the app, resulting in 2,845 people being alerted of exposure. The positive results were handled anonymously, with the infected persons identity unknown to people exposed to them.

The app used Bluetooth keys to identify app users who were within six feet of an infected person for 15 minutes or more.

Barton says the state will continue to do contact tracing to find and notify people exposed to infected people, although she didnt say how far-reaching the effort is. The latest recommendations from the U.S. Centers for Disease Control say people who get COVID-19 should stay home and away from other people for at least five days.

The app had many other features, including state and county-level data on COVID-19 infections and deaths, and information about COVID-19 vaccination locations.

Barton says people can continue to get that information from these sources:

Find a vaccine provider near you: https://www.vaccines.gov/

Track the level of COVID-19 activity in your community via the CDCs county-level map: https://www.cdc.gov/coronavirus/2019-ncov/your-health/covid-by-county.html

Get the latest weekly update on COVID-19 data in Pennsylvania online at: https://www.health.pa.gov/topics/disease/coronavirus/Pages/Cases.aspx

Check if you should get a COVID test on the When to Get Tested page: https://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.html

Find COVID-19 testing sites in Pennsylvania here: https://www.health.pa.gov/topics/disease/coronavirus/Pages/Symptoms-Testing.aspx

Review treatment options if you test positive: https://www.health.pa.gov/topics/disease/coronavirus/Pages/Prevention-Treatment.aspx

Correction: The health department says the app is unique to Pennsylvania.

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Pa. shuts down phone app that warns of exposure to COVID-19 - PennLive

The United States has relaxed most of the Covid-19 restrictions in many parts for a long time. But since then, the Covid-19 cases have also started to increase.

It is feared that the US is moving towards its second-largest wave, which may have already begun.

The country reported a huge number of cases while the pandemic was at its peak and was also one of the worst affected countries, with a large number of deaths being reported due to the infection.

In a matter of weeks, the BA.5 version of Covid-19 has become the predominantvariant of the virus in the country.

Also read |Macau uses two more casino hotels for COVID-19 medical facilities

The BA.5 variant can spread faster than other variants around the world.The infection rate is very high, which may lead to more problems.

It is one of Omicron's sub-variants. It is similar to the Ba 2 variant from last year but has its own mutations.

Watch |China's Xi'an, Shanghai & Macao put under COVID lockdown

Its spread depends on the population's immunity.

The Ba.5 variant may pose the biggest threat to immune protection yet in the US.

The BA.5 variant accounted for nearly 54 percent of Covid-19 cases in the country, according to the Centers for Disease Control and Prevention. The BA.4 variant accounted for 17%of the total.

The variants have also been shown to evade protection from vaccination and previous infections.

The symptoms vary from person to person. While some have a high fever, headache, runny nose, cough, etc., some show no symptoms at all.

Also read |COVID-19: Travellers warned of rising virus cases in Europe

According to a report by The Guardian, Jason Salemi, who is an associate professor of epidemiology at the University of South Floridas College of Public Health said,Covid-19 is very clearly not over. Were seeing dramatic increases in the number of cases and hospitalisations in many places throughout the United States".

BA.4 and 5 are potentially the variants that can break through immunity the easiest.They are capable of reinfection andwere headed in a bad direction, he added.

According to theUS Centers for Disease Control and Prevention (CDC), more than one in three Americans live in a county at medium risk from Covid, and one in five are at high risk. This is thehighest proportion of the country facing risks since February.

Though hospitalisations were fewer earlier, they have increased as the cases have started to rise.

Usually, people in their old age were hospitalised, but now hospitalisations are continuing for all ages.

Salemi also said that the first and second booster is very important.

However, only 34 percent of people in the US have received their booster doses. While after that the second booster dose has been taken by a very less number of people.

The US government as well as the citizensneed to takesome necessary precautions to prevent further spread of the infection and take the booster doses as well.

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Is America heading towards its second-largest Covid-19 wave? - WION

INDIANAPOLIS (WISH) March 11, 2020, marks a day in history we will never forget.

COVID-19 swept the world and was officially declared a pandemic, and, nearly two and a half years later, it still is.

So, when will we be able to put COVID-19 behind us?

In a mathematical study, researchers at Yale School of Medicine collected data on re-infection rates of a coronavirus similar to the common cold in rats. They modeled the exposure scenario of what happened so that it resembled the current COVID circulation and exposure to people in the United States.

The result? It will take another two years.

Coronaviruses are very unpredictable, so there could be a mutation that makes it more pathogenic, said lead study author Dr. Caroline Zeiss in a statement. The more likely scenario, though, is that we see an increase in transmissibility and probable decrease in pathogenicity.

By this, Zeiss means, COVID will still be transmitted between people but it will unlikely cause severe illness, much like the common cold.

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Scientists say they know when COVID-19 pandemic will be over - WISH TV Indianapolis, IN

Seoul, South Korea CNN

Choi Jung-hun smiled as I read out the latest official Covid-19 figures from North Korean state media: fewer than 5 million cases of fever and just 73 fatalities a fraction of the death toll of every other country in the world.

North Koreans call them rubber band statistics, he said, in a nod toward Pyongyangs flexibility with the truth. Its hard even for North Korea to know its own numbers.

He speaks with some authority. Choi was a doctor for more than 10 years in North Korea, specializing in infectious diseases before he fled his home country in 2011.

He can remember the SARS outbreak of 2002-2004, when he says hundreds of people in the northeastern city of Chongjin, where he was working, began dying after reporting cold or flu-like symptoms.

Doctors like Choi could only privately suspect SARS was to blame. North Korea had no ability to test for the disease, so officially it recorded zero infections. Its neighbor China reported more than 5,000 cases and hundreds of deaths.

Choi can also remember dealing with a nationwide measles outbreak in 2006, armed only with a thermometer; and a 2009 flu pandemic in which even more people died than during SARS a situation made worse by an acute shortage of medicine.

In previous epidemics, Choi explains, there was never an incentive for local officials to travel house to house to accurately count cases they had no masks or gloves and they figured statistics would be massaged by the regime to suit its needs.

He assumes little has changed since he left and that history, if not exactly repeating itself, is at least rhyming.

As with past outbreaks of disease in North Korea, one of the biggest concerns surrounding the countrys Covid outbreak is that Pyongyangs penchant for secrecy makes it hard to accurately gauge its severity.

International NGOs and most foreign embassies have long vacated the country and tightly sealed borders mean access is impossible, making the accounts of defectors like Choi all the more important.

Many were surprised by Pyongyangs decision in May to admit it was dealing with an outbreak, even if the accuracy of its statements since have faced skepticism. Early on, leader Kim Jong Un had described the outbreak as the greatest turmoil ever to befall the country. Two months and millions of suspected cases later, he claimed a shining success in stopping the disease in its tracks.

The incredibly low official death toll the country has reported inevitably raises suspicions that Pyongyang is trying to hide a bigger problem.

I have some questions, South Koreas Unification Minister Kwon Young-se said pointedly last week, noting the story being peddled by the Norths state-run media contrasted sharply to the experience of the rest of the world.

The biggest fear initially was that an outbreak in an unvaccinated, malnourished population with primitive health care would be catastrophic.

Tomas Ojea Quintana, UN Special Rapporteur for human rights in North Korea, said knowing the scale of the outbreak is impossible at the moment though he had heard unconfirmed reports of deaths among the elderly and malnourished children.

At least in my position, I am not able to contrast this fear that we had at the beginning of 2020 about the catastrophic consequences of Covid in (North Korea) and its current situation.

There are also fears that new, possibly more virulent, variants could emerge from unchecked transmission through North Koreas population of about 25 million.

Dr. Kee B. Park, an American neurosurgeon who until the pandemic started had been visiting North Korea twice a year to work alongside North Korean counterparts, training them and performing surgeries, said the country seemed unwilling to share information and this was not good for them (and) its not good for the rest of the world.

We have to share information on any kind of new changes in the characteristics of the virus, for instance, mutations, right, he said.

We need to be aware of the fact that high replication can lead to new variants. The only way to detect that is to share information with each other.

In June, North Korea said it was experiencing an outbreak of an unidentified intestinal disease in South Hwanghae Province, about 75 miles (120 kilometers) south of the capital Pyongyang.

At the very least, the announcement demonstrated the countrys vulnerability to disease outbreaks and its lack of medicines.

Park believes North Korea is probably dealing with an outbreak of typhoid fever or cholera.

Somewhere like North Korea, you can expect high rates of infectious diseases. In fact, for children under 5 years of age, diarrheal diseases are the number one killer.

One ray of hope for Park was the countrys ability to vaccinate its population quickly demonstrated during its nationwide inoculation program for the 2006 measles outbreak.

The first cycle, they were averaging a million jabs a day, then at the second cycle, later on in 2007, they were averaging over 3 million injections a day, Park said.

If all conditions are right, based on those numbers, they can vaccinate the entire population at least for the first jab in eight days.

But any optimism is tempered by the reticence of a country sometimes referred to as the hermit nation to accept outside help.

Theyre socialized for scarcity, Park said. They struggled to supply hospitals with some of the things we take for granted, he recalled of his time working in the country, saying surgeons would reuse equipment such as scalpels until they were blunt and unusable.

Offers of aid from the United Nations, United States, South Korea and others have all been ignored.

Some aid, however, has made its way into the country from China. Customs data shows from January to April, North Korea imported more than 10 million masks, 1,000 ventilators and more than 2,000 kilograms of unspecified vaccines.

Global vaccine alliance Gavi said last month it understood North Korea had accepted Covid vaccines from China and had started administering doses.

A Gavi spokesperson told CNN that North Korea had still not submitted a formal request to COVAX for vaccine support but we remain ready to help should they do so.

The isolation of Covid sufferers in the country was highlighted by the recent attempts of a defectors activist group to send medicine across the demilitarized zone the de facto border between North and South Korea.

The Fighters to Free North Korea said it had sent large balloons carrying medical supplies such as Tylenol and Vitamin C across the border in June as well as some carrying anti-regime leaflets in late April.

These balloon flights are against South Korean law and have been discouraged. Unification Minister Kwon told reporters he understands such organizations sentiments, but I think they should refrain.

Meanwhile, disease whether its Covid or anything else may not be the biggest problem facing North Koreans.

One defector, 44, who is living in South Korea, said she had been contacted by her family in the North soon after the outbreak was reported. Conversely, when it came to Covid, they were most concerned about her a reflection of Pyongyangs considerable propaganda prowess.

They said [North Korean television had] reported that many people in South Korea were dying from Covid so they were worried about me, she said. They werent very concerned about the virus.

What her family were extremely worried about, however, was the lack of food.

They told me that the food situation was worse than during the Arduous March in the 1990s Im very worried knowing how difficult things were (back then).

The Arduous March refers to a period of devastating famine when North Koreas economy took a hammer blow from the collapse of the Soviet Union, which ended the flow of aid into the country.

Hundreds of thousands of people, or as many as 10% of the countrys population, are estimated to have starved to death. Some estimates put the death toll even higher.

The defector did not ask her family whether anyone is dying from starvation as she never talks about anything political during these rare contacts with her family. The possibility that authorities might be listening in is too great. She asked CNN not to be identified in case her family faced retribution.

But Quintana, the UN Special Rapporteur, said the danger was very real and that he was urging the Kim regime and others involved in North Korea to basically understand there is a serious risk about starvation in North Korea.

Whether Kim is likely to listen is another matter.

State-run television has been running coverage of the North Korean leader touring pharmacies, ordering his military to stabilize medical provisions, and even donating some of his private medical supplies last month to the fight against the as-yet unidentified intestinal outbreak.

To Choi, the doctor who fled North Korea in 2011, such images are to be expected when truth is treated like a rubber band. Its a show and nothing more, he said.

The North Korean authorities are not struggling, North Korean citizens are the ones having a hard time if you survive its great, but theres nothing we can do if you die.

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Is North Korea hiding a bigger problem behind its Covid-19 outbreak? - CNN

NEW YORK and MAINZ, GERMANY, July 8, 2022 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) approved the companies supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The vaccine was previously made available to this age group in the U.S. under emergency use authorization (EUA), and to date more than 9 million 12- to 15-year-old adolescents in the U.S. have completed a primary series.i

Todays approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. A two-dose primary series of the vaccine (30-g dose) elicited SARS-CoV-2neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compared well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. In the trial, a two-dose primary series of the vaccine (30-g dose) was also 100% effective (95% confidence interval [CI, 87.5, 100.0]) in preventing COVID-19, measured between a week and more than four months after the second dose. During this time, all 30 cases of confirmed symptomatic COVID-19 were in the placebo group (n=1,109) and no cases were in the COMIRNATY group (n=1,119). The only SARS-CoV-2 variant of concern identified from the confirmed COVID-19 cases in this age group was Alpha as the efficacy analysis was conducted between November 2020 and May 2021, which was before the Delta and Omicron surges. No cases of severe disease occurred in either the COMIRNATY or placebo group. The adverse event profile was generally consistent with other clinical data for the vaccine, with a favorable safety profile observed across 6 months of safety follow-up data after the second dose.

Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.

COMIRNATY is now the only COVID-19 vaccine approved by the FDA as a two-dose primary series for individuals 12 years and older. An EUA for a primary series in U.S. adolescents ages 12 through 15 years was previously granted in May 2021 based on initial data from the same pivotal Phase 3 clinical trial. Longer-term follow-up data, announced in November 2021, confirmed the safety and effectiveness of COMIRNATY in adolescents 12-15 years of age and were required for licensure. In the European Union the conditional marketing authorization in this age group was granted by EMA in August 2021.

COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Pfizer and BioNTech have also submitted a sBLA to the U.S. FDA to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older, who are currently authorized under EUA.

COMIRNATY, which is based on BioNTechs proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Pfizer and BioNTech also are pursuing regulatory approvals for this age group in other countries where emergency use authorizations or equivalents have been granted.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

Booster Series

COMIRNATY INDICATIONCOMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

COMIRNATY AUTHORIZED USESCOMIRNATY (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

Booster Dose

Emergency Use AuthorizationEmergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

INTERCHANGEABILITYFDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of your medical conditions, including if you:

Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients

You should not receive COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine if you have had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of COMIRNATY or Pfizer-BioNTech COVID-19 Vaccine.

There is a remote chance that COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If the vaccine recipient experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, particularly 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age.

Seek medical attention right away if you have any of the following symptoms after receiving the vaccine:

Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine

Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA)

In people 12 through 15 years of age, the most common side effects (8%) were pain at the injection site, fatigue, headache, chills, muscle pain, fever, joint pain, injection site swelling, and injection site redness.

In people 16 through 55 years of age, the most common side effects (10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, fever, and injection site swelling.

In people 56 years of age and older, the most common side effects (10%) were pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, injection site swelling, fever, and injection site redness.

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older:

Recipients and Caregivers Fact Sheet (6 months through 4 years of age)Recipients and Caregivers Fact Sheet (5 through 11 years of age)Recipients and Caregivers Fact Sheet (12 years of age and older)COMIRNATY Full Prescribing Information (16 years of age and older), DILUTE BEFORE USE, Purple CapCOMIRNATY Full Prescribing Information (16 years of age and older), DO NOT DILUTE, Gray CapEUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon CapEUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange CapEUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple CapEUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap

About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure NoticeThe information contained in this release is as of July 8, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the approval of the vaccine for use in individuals 12 years through 15 years of age, the sBLA submission to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older, who are currently authorized under EUA, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release, for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies, or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when other potential submissions to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older will be submitted and whether and whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination) and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the application submission to the FDA to extend the approval of COMIRNATY to include booster doses for individuals ages 16 years and older or any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates, or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit http://www.BioNTech.com.

BioNTech Forward-looking StatementsThis press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the sBLA approval of the vaccine for use in individuals 12 years through 15 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or emergency use authorization or equivalent in additional populations, for a potential booster dose for BNT162b2 or any potential future vaccines including a potential variant based, higher dose, or bivalent vaccine (including potential submissions for a potential booster dose for children 5 through 11 years of age and potential future annual boosters or re-vaccinations); our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the demand for any products may be reduced or no longer exist; the availability of raw materials to manufacture a vaccine; the ability of BioNTech to supply the quantities of BNT16b2 to support clinical development and market demand, including our production estimates for 2022; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTechs trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report as Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2022, which is available on the SECs website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

# # #

i Centers for Disease Control and Prevention. COVID-19 Vaccination Demographics in the United States,National. Available at: https://data.cdc.gov/Vaccinations/COVID-19-Vaccination-Demographics-in-the-United-St/km4m-vcsb/data. Accessed May 2, 2022.

Pfizer:Media Relations+1 (212) 733-7410[emailprotected]

Investor Relations+1 (212) 733-4848[emailprotected]

BioNTech:Media RelationsJasmina Alatovic+49 (0)6131 9084 1513[emailprotected]

Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074[emailprotected]

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Pfizer and BioNTech Announce US FDA Approval of their COVID-19 Vaccine COMIRNATY For Adolescents 12 through 15 Years of Age - Pfizer