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PURI PEDIATRIC
Medical Group, Inc.
2243 Mowry Ave., Suite F
Fremont, CA 94538
The drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19, a promising development as the world has waited anxiously for any positive news about a pandemic that has killed more than 1.2 million people.
Pfizer, which developed the vaccine with the German drugmaker BioNTech, released only sparse details from its clinical trial, based on the first formal review of the data by an outside panel of experts.
The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines for diseases such as measles. No serious safety concerns have been observed, the company said.
Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this month, after it has collected the recommended two months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 million to 20 million people, company executives have said.
“This is a historical moment,” said Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer. “This was a devastating situation, a pandemic, and we have embarked on a path and a goal that nobody ever has achieved — to come up with a vaccine within a year.”
The news comes just days after Joseph R. Biden Jr. clinched a victory over President Trump in the presidential election. Mr. Trump had repeatedly hinted a vaccine would be ready before Election Day, Nov. 3. This fall, Pfizer’s chief executive, Dr. Albert Bourla, frequently claimed that the company could have some indication of whether the vaccine worked by October, something that did not come to pass.
Stocks surged on the news. The S&P 500 gained 1.2 percent Monday, ending the day just short of a high reached in early September. Shares of companies that stand to gain most from the return of normal activity — like airlines and shopping mall operators — soared, while those whose businesses were well suited under lockdowns were sharply lower.
Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. And no one knows how long the vaccine’s protection might last. Still, the development makes Pfizer the first company to announce positive results from a late-stage vaccine trial, vaulting it to the front of a frenzied global race that began in January and has unfolded at record-breaking speed.
Eleven vaccines are in late-stage trials, including four in the United States. Pfizer’s progress could bode well for Moderna’s vaccine, which uses similar technology. A Moderna spokesman said that it expected interim findings from its study this month.
Operation Warp Speed, the federal effort to rush a vaccine to market, has promised Pfizer $1.95 billion to deliver 100 million doses to the federal government, which will be given to Americans free of charge. But Dr. Jansen sought to distance the company from Operation Warp Speed and presidential politics, noting that the company — unlike the other vaccine front-runners — did not take any federal money to help pay for research and development.
“We were never part of the Warp Speed,” she said on Sunday. “We have never taken any money from the U.S. government, or from anyone.” On Monday, a spokeswoman for Pfizer clarified that the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccine.
Dr. Jansen said she learned of the results from the outside panel of experts shortly after 1 p.m. on Sunday, and that the timing was not influenced by the election. “We have always said that science is driving how we conduct ourselves — no politics,” she said.
The data released by Pfizer Monday was delivered in a news release, not a peer-reviewed medical journal. It is not conclusive evidence that the vaccine is safe and effective, and the initial finding of more than 90 percent efficacy could change as the trial goes on.
“We need to see the actual data, and we’re going to need longer-term results,” said Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University. Still, he said, “it’s a testament to hard work and science that we’re getting results that are so good and so fast.”
Other scientists were stunned by the data so far.
“This is really a spectacular number,” said Akiko Iwasaki, an immunologist at Yale University. “I wasn’t expecting it to be this high. I was preparing myself for something like 55 percent.”
If the final vaccine ends up with that level of efficacy, it “would be higher than your regular flu vaccine, and this vaccine could have a serious impact on bending the curve of this outbreak,” said Dr. Saad B. Omer, the director of the Yale Institute for Global Health.
Dr. Jansen said that because the trial is continuing, an independent board reviewing the data has not told her or other company executives other details, such as how many of the people developed mild versus more severe forms of Covid-19 — crucial information that the F.D.A. has said it will need to evaluate any coronavirus vaccine. The agency has also asked for other detailed manufacturing and safety data that could take weeks to review.
Half of the participants received two doses of the vaccine three weeks apart, and half received a placebo. The first analysis was based on 94 volunteers who developed Covid-19. Dr. Jansen said the outside board did not say how many of those cases came from participants who had been vaccinated. But with a rate of more than 90 percent effectiveness, most had to have been in the placebo group.
Dr. Jansen said the global surge in coronavirus infections contributed to the speed with which participants in the trial got infected with the virus. “You can see for yourself, the rates are going up everywhere,” she said. “So we think based on our predictions, it shouldn’t take us very long” to get to 164 cases of Covid-19.
Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the F.D.A.’s vaccine advisory panel, said the news that Pfizer’s trial was progressing quickly was a good sign for other trials.
“If there’s any silver lining in the fact that our country is currently on fire with this virus, it’s that these trials can reach a conclusion much quicker than otherwise,” he said.
Work on the vaccine began in Mainz, Germany, in late January, when Ugur Sahin, the chief executive and co-founder of BioNTech, read about the virus in the Lancet that filled him with dread. “I almost instantly knew that this would affect us,” Mr. Sahin said. That same day, the first European cases were detected, in France.
Mr. Sahin assembled a 40-person team to work on the vaccine. Many employees canceled vacations and Mr. Sahin authorized overtime pay. They called it Project Lightspeed.
BioNTech used a technology that had never been approved for use in people. It takes genetic material called messenger RNA and injects it into muscle cells, which treat it like instructions for building a protein — a protein found on the surface of the coronavirus. The proteins then stimulate the immune system and are believed to result in long-lasting protection against the virus.
BioNTech quickly identified 20 vaccine candidates, and began testing them on rodents. But the company lacked the experience and resources to rapidly conduct a major clinical trial. So Mr. Sahin called Pfizer. The two companies had been working to develop a flu vaccine since 2018, and within a day of Mr. Sahin calling Dr. Jansen at Pfizer, the companies agreed to partner on a coronavirus vaccine. In mid-March, the companies announced their partnership.
After early human trials, they determined that two vaccine candidates produced a robust immune response, including antibodies against the virus and powerful immune cells known as T cells. They chose the one with fewer side effects to start a trial with more than 30,000 volunteers in the United States, Argentina, Brazil and Germany. In September the company expanded the trial to 44,000 participants.
Even before the trial began, the Trump administration placed a bet that Pfizer and BioNTech would succeed, announcing its advance purchase deal on July 22. At the time, it was the largest such commitment from the U.S. government.
From time to time over the past seven months, while working from his home in the affluent suburb of Scarsdale, N.Y., Dr. Bourla spoke with Mr. Trump, who had tied progress on a vaccine to his election hopes. Dr. Bourla said the president pressed for details about when the vaccine might be ready.
“Every time I spoke with the president I told him that he should not worry about us compromising safety or efficacy, but that we would do it as quickly as science allows us,” he said.
Late this summer, as the president made public pronouncements about a vaccine coming soon, Dr. Bourla boarded a Pfizer jet to Frankfurt to pick up Mr. Sahin. The two men were meeting face-to-face for the first time, but there was little time for pleasantries, or even science.
As they descended toward a factory in Austria that would produce their vaccine, they discussed how to ensure a wary public would trust their vaccine. Days later, Pfizer organized an effort by major drug companies to pledge that any coronavirus vaccine would stand up to scientific scrutiny.
In another move to shore up public confidence and after criticism from outside researchers, Pfizer and other companies took the unusual step of releasing their trial blueprints, known as protocols, revealing typically secret details about how it was evaluating its vaccine.
Two days after Mr. Trump called out Pfizer by name in the first presidential debate, saying it and other vaccine makers were being hampered by politics, Dr. Bourla emailed Pfizer employees.
“We are approaching our goal,” he wrote. “And despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. Presidential election.”
The trial’s protocol allowed four interim analyses — early looks that would give the outside board of experts a chance to identify safety concerns, and assess whether the vaccine was working.
Dr. Bourla’s confidence that the trial could yield October results centered on the first interim analysis, which was supposed to have taken place after 32 people in the study developed Covid-19.
However, regulators at the F.D.A. had always been skeptical that data from so few people would be enough to merit an authorization. The company said that, after discussing the matter with the F.D.A., it decided that the virus was spreading fast enough to wait until the pre-scheduled second analysis — at 62 cases. But 94 cases had accrued by the time the company had finished discussions with the agency and the independent board was ready to look at the data on Sunday.
“It turned out we had even far more than what we expected,” Dr. Jansen said. So the outside panel reviewed 94 cases — more than half of the 164 needed to complete the trial.
Wide distribution of Pfizer’s vaccine will be a logistical challenge. Because it is made with mRNA, the doses will need to be kept at ultra cold temperatures. While Pfizer has developed a special cooler to transport the vaccine, equipped with GPS-enabled thermal sensors, it remains unclear where people will receive the shots, and what role the government will play in distribution.
Most experts say the world will need many treatments and vaccines to bring an end to the pandemic.
“There’s a lot at stake for humanity,” Dr. Bourla said.
Katie Thomas, David Gelles and Carl Zimmer. “Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective.” The New York Times, 9 Nov. 2020
https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html?campaign_id=60&emc=edit_na_20201109&instance_id=0&nl=breaking-news&ref=cta®i_id=57181407&segment_id=44009&user_id=93af30c6891411cbc0d0a6fc58548355
NEW DELHI – The Central Government Nov. 5 issued a set of fresh guidelines for those travelling to India from abroad under which travelers seeking exemption from institutional quarantine will have to submit a negative RT-PCR report conducted within 72 hours of undertaking the journey.
In the new guidelines, the union health ministry stated, “ Travelers may seek exemption from institutional quarantine by submitting a negative RT-PCR test report. This test should have been conducted 72 hours prior to undertaking the journey. ”
International passengers arriving without the certificate and wishing to seek exemption from institutional quarantine can now also avail the facility available at the airports. Those coming without the certificate but not opting for the test at the airport, will have to undergo mandatory seven days’ institutional quarantine and seven days’ home quarantine.
“ Only for compelling reasons or cases of human distress such as pregnancy, death in family, serious illness and parent with children of the age of 10 years or below, home quarantine may be permitted for 14 days, ” the guidelines added. For seeking exemption, they would need to apply to the online portal at least 72 hours before boarding.
The passengers who have been exempted from institutional quarantine will show the same to the respective state counters on their cell phones or via other mode before being allowed to quarantine at home for 14 days.
The standard operating procedure added, “ The remaining passengers shall be taken to suitable institutional quarantine facilities, to be arranged by the respective State, UT Governments to undergo mandatory seven days institutional quarantine and seven days home quarantine. ”
The passengers arriving through seaports or land ports will also have to undergo the same protocol as above, except that facility for online registration is not available for such passengers currently, the guidelines further stated.
“ Such passengers shall submit the self-declaration form to the concerned authorities of Government of India at seaports, land ports on arrival. If found negative, they shall be advised to self-monitor their health for additional 7 days, ” it said.
IANS. “Indian Govt. Issues Fresh Guidelines for Those Travelling to India From Abroad.” IndiaWest, 5 Nov. 2020, https://www.indiawest.com/news/india/indian-govt-issues-fresh-guidelines-for-those-travelling-to-india-from-abroad/article_a3aee092-1f97-11eb-8ae1-db0dcc156bb6.html.
Today’s unprecedented pandemic has caused an almost impossible amount of uncertainty throughout the United States; as parents during this time, keeping you and your children safe and healthy is a vital role to play, but a hard one. As pediatricians, our main concern with our patients involves keeping families healthy with the best resources available and keeping up motivation and optimism as much as possible throughout this pandemic. We’re all in this together, and as this year passes, we’re here to provide you with some of the best ways to keep yourselves healthy as the winter season brings the flu, the reopening of schools, and pandemic fatigue.
For the next several months, infections, hospitalizations, and deaths are expected to rise and spread further, but it does not mean that your fall and winter seasons need to be miserable. Here are some ways to stay healthy, both physically and mentally, for you and your children during this time.
Among the recommended regulations set forth by the CDC, which include hand-washing, social distancing, and wearing face masks while outside, one of the best ways to keep yourself healthy is to stay within your family and have your family be your immediate circle. By maintaining these boundaries, these will be your strongest weapons against Covid-19.
Managing multiple schedules, helping your child through online school work, and keeping yourself in check will be challenging, but making sure that you practice self-care will allow you not to wear yourself down. Be gentle with yourself and each other.
When raising children, children heavily rely on and react to the words you say and how you say them. Find reassurance words throughout this fall, encourage them to feel, and be okay with being upset. The CDC provides more extensive information for parents wishing to learn more.
Some cities will be more affected than others; some mobile apps and websites offer updates on the Covid-19 situation in your area and help give you and your family a better idea of what activities will be at higher risk than others. By searching for these resources, you can better plan your outdoor and indoor activities.
Routines can be especially important for children. With increased uncertainty and stress, at-home and at-school routines can allow you to have an easier time managing emotions and behaviors. For mental health, spend a certain amount of time outdoors in a secluded area for fresh air, plan indoor crafting activities, and include times for fun and relaxation.
Most often, the spread of Covid-19 occurs not informal settings with strangers, but most often informal gatherings with friends and family. If you must travel during the holidays, cut out risky areas such as restaurants and hotels. Get you and your family tested before visiting loved ones to keep you and your family safe.
If you visit a pediatrician, you know that your pediatrician can provide your child with up-to-date vaccinations and health checkups to assure you that your child is best protected. Their developmental milestones still matter at this age because their growth and health matters now more than ever.
If you sense that your child may have Covid-19, call Puri Pediatric Group, located in Fremont, CA, receive advice about caring for your child from Dr. Veena Puri to help manage the disease and help them recover.
Today’s pandemic-filled world and social distancing guidelines have led to teenagers flooding social media platforms such as Tik Tok. Social media has become one of our main gateways for communicating and spreading ideas, some of which not so good. With the recent alarm the Benadryl challenge, this trend has begun to spread across the Tik Tok platform to take dangerously high amounts of Benadryl. Medical experts have been warning parents across social media of this trend, and how it can be fatal to their children. But how can you, as a parent, do ahead of time to help prevent these risks?
Benadryl is medically known as diphenhydramine, a type of antihistamine used to relieve the symptoms of allergies, hay fever, and the common cold. Benadryl works by blocking the histamines (H1) receptors from interacting with the body during an allergic reaction. The histamine receptors are prevented from accessing the airways, blood vessels, and gastrointestinal tract. Benadryl also blocks the acetylcholine receptors, sodium channels, and inhibitors for serotonin, responsible for many of the sedative effects of the medication.
The Benadryl brand recommends that children between ages 6 and 12 take one tablet every four to six hours, and for those older than 12, take two tablets every four to six hours. The maximum dosage is 300 mg a day and is smaller for children who weigh less. Normally, Benadryl treats allergic reactions when properly used, including sneezing, itching, watery eyes, and runny nose. It can relieve nausea and vomiting and help people fall asleep. It can be a great way to treat common colds and signs of the flu.
For adults taking this medication, drowsiness, dizziness, low blood pressure, abdominal discomfort, and rapid heart rate are all some of the side effects that can occur with Benadryl. Many of this medication’s effects can even last into the next day, but with normal dosages, these side effects will normally subside. Overdosing, however, has and can lead to dangerous consequences.
Benadryl is harmful in large amounts, and when a person overdoses on this medication, many tend to experience anticholinergic poisoning. The diphenhydramine during an overdose interacts with more than just the histamine receptors. It begins to react with the organs and brain because of the bi-lipid (fat) layer surrounding the cells. Benadryl is lipophilic, meaning it dissolves in fat. When the Benadryl reaches the brain and organs, it blocks the histamine cells in the brain, causing a lack of cognition, and then interact with the acetylcholine receptors that control resting and digestion, explaining many of the symptoms associated with the overdose, including seizures, dry mouth, palpitating heart rate, and low blood pressure.
As parents, the best way to prevent a Benadryl overdose is to educate your children about these effects and warn them not to take part in the challenge. If needed, keep these medicines away from your children in a secure, secret place to prevent them from accessing this medication. Reinforce what Benadryl is for, talk to your child about the ideas they’re exposed to while on social media, and support them the best you can. In any case of an overdose, please call your local poison control center, and call 911.
For the best in pediatric care, schedule an appointment at Puri Pediatric Medical Group, located in Fremont, CA, to gain advice for child care under the expertise of pediatrician Dr. Veena Puri.
2020 has been a harrowing year for families, with the Coronavirus, COVID-19, tearing its way through the country and the world. Every day new information is found about this disease as we gain additional information and understanding of how it works. The controversial decision to send children back to school in an uncontrolled pandemic has many parents worried, and recent updates are emphasizing the validity of that concern. While most of us know by now which symptoms to look for to identify COVID, there’s a growing body of data that suggests an unexpected element of this disease.
One of the most troubling pieces of data to come out of the intense research being done on this virus is the possibility that as much as 45% of children are asymptomatic carriers of the disease. This means that these children may be infected with COVID-19 but not experiencing any symptoms that indicate this. Further, a significant portion of those children who had contracted the disease and recovered were still capable of passing the virus to others as much as three weeks after they were deemed recovered. The current quarantine period for COVID is two weeks, meaning that some of these children are being released from quarantine while they are still capable of spreading the disease. The implications of this information are worrying, to say the least.
There remains a vast amount to be learned about this virus, but some authorities are already taking action in response to this news. The Mayor of New York City responded by pushing the start date for schools back an additional 11 days from the initial Sept 10th date. This date would then be pushed back again to Oct 1st to permit schools to take additional steps to prepare. For its part, California has taken steps to reduce the number of students attending schools in person in efforts to reduce the risk of spreading the disease. Some schools that refused to adhere to the guidelines set by the California state government have been ordered to close their doors in response to parent complaints. Larger districts, including LA and San Diego, have forbidden in-person classes entirely, taking their education strictly online.
Unfortunately, there are still shortages in the necessary supplies to perform the degree of testing that would be necessary to identify every case of this disease. The best thing you can do for your child is to maintain social distancing and mask-wearing practices while emphasizing the importance of sanitation. If your child appears to be exhibiting any signs of COVID, it’s time to have them tested. You may also want to have a follow-up test done two weeks after the end of apparent symptoms in children who contract the disease.
Want to learn more about protecting your children in a pandemic? Reach out to Dr. Veena Puri at the Puri Pediatric Group in Fremont, CA, today! We work closely with patients to help maintain the health of them and their families throughout this trying time.
The current fires across the Bay Area are impacting many people in our community. Stanford Health Care is concerned for your health and we remain open to provide care during this time.
Many people experience uncomfortable symptoms as a result of unhealthy air quality. These may include burning eyes, runny nose, sore throat, cough, wheezing, or difficulty breathing. It’s especially important for you to pay attention to local air quality reports during a fire if you are:
If you are in one of these groups, or care for someone in one of these groups, please contact your healthcare provider if the event of increased symptoms. If you need immediate attention, call 911 or go to your nearest emergency department.
During this time, everyone is encouraged to protect themselves by doing the following:
Medical Group, Inc.
2243 Mowry Ave., Suite F
Fremont, CA 94538