Tag: Protection

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Mixing Pfizer, AstraZeneca Vaccines Provides Sturdy Covid Safety, Research Finds

Mixing Pfizer, AstraZeneca Vaccines Gives Strong Covid Protection, Study Finds

Initial results from a UK vaccine study suggest that mixing different brands of vaccine can produce a protective immune response against Covid-19. In the study, volunteers produced high levels of antibodies and immune cells after receiving a dose of the Pfizer BioNTech vaccine and a dose of the AstraZeneca Oxford shot.

Giving the vaccines in any order will likely provide effective protection, said Dr. Matthew Snape, a vaccines expert at Oxford University, at a news conference Monday. “Any of these schedules I think could be argued and expected to be effective,” he said.

Dr. Snape and his colleagues began the study called Com-COV in February. In the first wave of the study, they gave 830 volunteers one of four vaccine combinations. Some received two doses from Pfizer or AstraZeneca, both of which have been shown to be effective against Covid-19. Others got a dose of AstraZeneca, followed by one from Pfizer, or vice versa.

With the first wave of volunteers, the researchers waited four weeks between doses. Studies have shown that the AstraZeneca vaccine offers greater protection when the second dose is delayed for up to 12 weeks. Therefore, the researchers are also conducting a separate 12-week study that should provide results over the next month.

The researchers found that volunteers reported more chills, headaches, and muscle aches than people who received two doses of the same vaccine. But the side effects were short-lived.

Dr. Snape and his colleagues then took blood samples to measure the immune response in the volunteers. They found that those who received two doses of Pfizer-BioNTech produced antibody levels about 10 times higher than those who received two doses of AstraZeneca. Volunteers who received Pfizer followed by AstraZeneca showed antibody levels about five times higher than those who received two doses of AstraZeneca. And volunteers who received AstraZeneca followed by Pfizer achieved antibody levels about as high as those who received two doses of Pfizer.

Dr. Snape said the differences would most likely decrease in the volunteers who received a second dose after 12 weeks when the AstraZeneca vaccine had more time to intensify its effects.

The study also found that using different vaccines produced higher levels of immune cells prepared to attack the coronavirus than when giving two doses of the same vaccine. Dr. Snape said it was not yet clear why mixing had this advantage. “It’s very fascinating, let’s say so much,” he said.

Dr. Snape and colleagues have started a similar study, adding Moderna and Novavax vaccines to their list of possibilities.

For now, he said, the best course of action remains to get two doses of the same vaccine. Large clinical studies have clearly shown that this strategy reduces the likelihood of developing Covid-19. “Your default should be what has been shown to work,” said Dr. Snape.

But there are many cases where that is not possible. Vaccine deliveries are sometimes delayed due to manufacturing issues, for example. Younger people in some countries have been advised not to receive a second dose of AstraZeneca due to concerns about the low risk of blood clots. In situations like this, it’s important to know if people can switch to another vaccine.

“This provides reassuring evidence that should work,” said Dr. Snape.

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What Satisfied Me to Begin Sporting Solar Safety

What Convinced Me to Start Wearing Sun Protection

Alas, those of us in the upper decades of life knew little in our younger years about the risks of sun damage beyond the need to avoid a bad sunburn. Many youngsters like me swam, hiked, biked and played sports minimally clothed while the sun tanned or burned our skin. We sunbathed coated in baby oil in a misguided effort to acquire a rich tan. And many of us, myself included, failed to reach adulthood with sun-protective habits that could have prevented the skin damage now woefully apparent.

Given that the risk of ultraviolet light to healthy skin has since been widely publicized, I’m astonished at how many people today visit tanning salons or use tanning beds at home, damaging the wholesome cutaneous barrier nature gave us.

Happily, the new study suggests that more people now have a greater understanding and respect for the sun’s effects on skin and can look forward to a healthier future, said Dr. Sangeeta Marwaha, a dermatologist in Sacramento and co-author of the study. Among people who entered the study in 2018, the risk of developing skin cancer was two-thirds that of study entrants in 2008 who were followed for an equal number of years.

“There’s been an increase in sun-protective habits and a resulting decrease in the development of skin cancer,” Dr. Marwaha said in an interview. “Parents today are more likely to protect their children from undue sun exposure, and the use of sunscreen is now more mainstream.”

But there’s still a long way to go. Fostering a healthy respect for sun protection in young children is especially important because some experts estimate that up to 80 percent of a person’s lifetime sun exposure is acquired before age 18.

Repeated exposure to the sun’s ultraviolet radiation causes most of the skin changes — wrinkles, age spots and tiny broken blood vessels — generally considered a normal result of aging. Yes, aging plays a role, but these effects occur much earlier in life on sun-exposed skin. UV light damages the elastin fibers in skin, causing it to stretch, sag and wrinkle. It also damages surface blood vessels, rendering them more fragile and easily bruised.

And Zachary W. Lipsky, a biomedical engineer at Binghamton University, found that UV radiation weakens the bonds that help the cells in the top layer of skin stick together, damaging the skin’s structural integrity and leaving it more vulnerable to infection.

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Two doses of Covid vaccines present safety in opposition to India variant

Two doses of Covid vaccines provide protection against India variant

A healthcare worker holds syringes with the Moderna and Pfizer vaccines against the coronavirus disease (COVID-19) at a vaccination centre, in El Paso, Texas, May 6, 2021.

Jose Luis Gonzalez | Reuters

A new study has found that two doses of either the Pfizer-BioNTech or AstraZeneca-University of Oxford vaccine give effective protection against the Covid variant first discovered in India, however it underscored the need for two doses, as both vaccines were significantly less effective after only one shot.

The study, led by Public Health England, also found that two doses of one of those vaccines were similarly as effective at protecting against the variant that first emerged in the U.K. and has since become a dominant strain in the West.

Dr. Jenny Harries, CEO of the U.K. Health Security Agency, told the BBC that the study provided the “first real-world evidence of vaccine effectiveness” against the variant first identified in India.

Conducted between April and May, the research found that the Pfizer-BioNTech vaccine was 88% effective against symptomatic disease from the B.1.617.2 Covid variant — a subtype of a variant that emerged in India last fall which has since spread to Europe — two weeks after the second dose. The vaccine was 93% effective two weeks after the second dose against the B.1.1.7 variant. which was first discovered in the U.K. last fall.

Meanwhile, two doses of the AstraZeneca vaccine were found to be 60% effective against symptomatic disease from the B.1.617.2 variant from India, compared with 66% effective against the strain from the U.K.

“Vaccine effectiveness against symptomatic disease from the B.1.617.2 variant is similar after 2 doses compared to the B.1.1.7 (Kent) variant dominant in the U.K., and we expect to see even higher levels of effectiveness against hospitalisation and death,” the study authors wrote. The results were published Saturday as a preprint and the study has not yet been peer-reviewed.

PHE said the difference in effectiveness between the vaccines after two doses “may be explained by the fact that rollout of second doses of AstraZeneca was later than for the Pfizer-BioNTech vaccine, and other data on antibody profiles show it takes longer to reach maximum effectiveness with the AstraZeneca vaccine.”

However, both vaccines were only 33% effective against symptomatic disease from B.1.617.2 three weeks after the first dose. In the same time frame, they were found to be 50% effective against the B.1.1.7 variant.

Variant of concern

The variant first discovered in India has been blamed for causing a dramatic third wave of infections in the country, overwhelming hospitals and causing thousands of deaths this spring. There were concerns that Covid vaccines could be rendered less effective by the variant so the latest data should help allay those worries.

The India variant has been detected in numerous other countries now, according to the World Health Organization, which dubbed it a “variant of concern” in early May.

The PHE study analyzed data from 1,054 people, of all age groups and several ethnicities, confirmed as having the B.1.617.2 variant through genomic sequencing. The data was collected from April 5 and hence covers the period since the B.1.617.2 variant (one of three variant subtypes found in India) emerged in parts of the U.K.

“As with other variants, even higher levels of effectiveness are expected against hospitalisation and death. There are currently insufficient cases and follow-up periods to estimate vaccine effectiveness against severe outcomes from the B.1.617.2 variant. PHE will continue to evaluate this over the coming weeks,” the study’s authors added.

Responding to the study, the U.K.’s health secretary, Matt Hancock, described the findings as “groundbreaking – and proves just how valuable our Covid-19 vaccination programme is in protecting the people we love.”

The U.K. has given more than 22 million people two doses of a Covid vaccine, while 72% of the population (or almost 40 million people) have had one shot, government data shows.

Hancock said the latest data emphasized “how important the second dose is to secure the strongest possible protection” against Covid-19 and its variants.

Separate PHE analysis indicated that the country’s Covid-19 vaccination program has so far prevented 13,000 deaths and around 39,100 hospitalizations in older people in England, up to May 9.

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Vaccinated individuals who had Covid might have extra safety in opposition to variants

Vaccinated people who had Covid may have more protection against variants

Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, speaks during a press conference at the White House in the James Brady Press Briefing Room of the White House on January 21, 2021 in Washington, DC.

Alex Wong | Getty Images

People who had Covid-19 and were later vaccinated may have more protection from highly contagious variants, said White House chief medical officer Dr. Anthony Fauci, on Wednesday.

Fauci cited a study published in late April that found that people with previous coronavirus infections had better immune responses to B.1.1.7 and B.1.351, first used in the UK and the South, after a dose of the Pfizer BioNTech vaccine identified variants of Africa compared to those that did not have Covid.

He cited an additional study published online that has not yet been peer-reviewed. It found that people with previous infections who were later fortified with two doses of an mRNA vaccine had “increased protection” against variants.

The studies provide more evidence of the benefits of vaccination, Fauci said.

“Vaccines are very effective,” Fauci said during a Covid briefing at the White House. “You are better than the response you get from a natural infection.”

His comments stem from the Biden government’s drive to partially vaccinate 70% of adults in the United States and 160 million adults fully by July 4th. This is a date the government hopes will mark a turning point in the pandemic.

Over the past few weeks, the pace of people getting their first doses of vaccine has slowed, despite U.S. health officials say they’re working to improve access to the shots and encourage more reluctant Americans to get vaccinated.

Earlier Wednesday, the Centers for Disease Control and Prevention released a new report forecasting Covid-19 cases to rise through May before falling sharply into July as vaccinations reduce infections.

Highly contagious variants, namely the highly contagious B.1.1.7 identified for the first time in Great Britain, remain a wild card, according to US health authorities. They urge Americans to get vaccinated and take safety measures against pandemics.

“We are seeing that our current vaccines protect against the pollutants circulating in the country. Put simply, the sooner more people are vaccinated, the sooner we will all get back to normal,” said CDC Director Dr. Rochelle Walensky during the press conference.

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The Paycheck Safety Program is out of cash and closed to most new functions.

The Paycheck Protection Program is out of money and closed to most new applications.

Four weeks before the planned end, the federal government’s signature assistance measures for small businesses – the Paycheck Protection Program – which had been devastated by the pandemic, ran out on Tuesday afternoon and no longer received most of the new applications.

Congress provided $ 292 billion to fund the program’s final round of loans. Almost all of the money has now been used up, the Small Business Administration running the program told lenders and their trading groups on Tuesday. (An earlier version of this item incorrectly stated that the actions it described took place on Wednesday.)

While many had predicted the program would run out of funds before the May 31 application deadline, the exact timing surprised many lenders.

“We understand that lenders are now receiving a message through the portal that loans cannot be granted,” the National Association of Government Guaranteed Lenders wrote in a warning to its members on Tuesday evening. “The PPP General Fund is closed to new applications.”

Some of the money – around $ 8 billion – remains available for financial institutions, which generally focus on lending to businesses run by women, minorities, and other underserved communities. These lenders can process applications until the funds are used up, as indicated by the trading group’s warning.

Small Business Administration officials did not immediately respond to a request for comment.

According to a lender who phoned SBA officials on Tuesday, lenders have some cash left to complete processing pending applications.

Since its inception last year, the Paycheck Protection Program has paid out $ 780 billion in inducible loans to fund 10.7 million applications, according to the latest government data. Congress renewed the program in the December bill, expanding the pool of eligible applicants and allowing the hardest-hit companies to return for a second loan.

Legislators extended the program’s deadline to May in March, but showed little enthusiasm for adding significantly more money to their coffers. With vaccination rates rising and pandemic restrictions easing, Congress’s focus on large-scale aid to small businesses has waned.

The government’s recent efforts have focused on the most severely damaged industries. Two new Small Business Administration scholarship programs – for companies in the live event and restaurant industries – have accepted applications in the past few weeks, although no scholarships have yet been awarded.

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Johnson & Johnson’s Vaccine Provides Sturdy Safety however Fuels Concern About Variants

Johnson & Johnson’s Vaccine Offers Strong Protection but Fuels Concern About Variants

[Live updates: follow our coverage of the coronavirus]

Johnson & Johnson announced on Friday that its one-dose coronavirus vaccine provided strong protection against Covid-19, potentially offering the United States a third powerful tool in a desperate race against a worldwide rise in virus mutations.

But the results came with a significant cautionary note: The vaccine’s efficacy rate dropped from 72 percent in the United States to 57 percent in South Africa, where a highly contagious variant is driving most cases. Studies suggest that this variant also blunts the effectiveness of Covid vaccines made by Pfizer-BioNTech, Moderna and Novavax. The variant has spread to at least 31 countries, including the United States, where two cases were documented this week.

Johnson & Johnson said that it planned to apply for emergency authorization of the vaccine from the Food and Drug Administration as soon as next week, putting it on track to receive clearance later in February.

“This is the pandemic vaccine that can make a difference with a single dose,” said Dr. Paul Stoffels, the chief scientific officer of Johnson & Johnson.

The Johnson & Johnson vaccine was 85 percent effective in preventing severe disease, regardless of what variant caused it, the company said. While less effective than the Moderna and Pfizer vaccines, Johnson & Johnson’s is still considered a strong vaccine by scientists. Annual flu vaccines, for example, are typically 40 to 60 percent effective.

The company’s announcement comes as the Biden administration is pushing to immunize Americans faster even with a tight vaccine supply. White House officials have been counting on Johnson & Johnson’s vaccine to ease the shortfall. But the company may only have about seven million doses ready when the F.D.A. decides whether to authorize it, according to federal health officials familiar with its production, and about 30 million doses by early April.

The variant from South Africa, known as B.1.351, could make things even worse for the vaccine push. Given the speed at which the variant swept through that country, it is conceivable that by April it could make up a large fraction of infections in the United States.

The fact that four vaccines backed by the federal government seem to be less effective against the B.1.351 variant has unsettled federal officials and vaccine experts alike. Facing this uncertainty, many researchers said it was imperative to get as many people vaccinated as possible — quickly. Lowering the rate of infection could thwart the contagious variants while they are still rare, and prevent other viruses from gaining new mutations that could cause more trouble.

“If ever there was reason to vaccinate as many people as expeditiously as we possibly can with the vaccine that we have right now, now is the time,” Dr. Anthony S. Fauci, the government’s top infectious disease expert, said in an interview. “Because the less people that get infected, the less chance you’re going to give this particular mutant a chance to become dominant.”

As the United States scrambles to get enough vaccines, the country is turning into something of an evolutionary experiment. The B.1.351 variant is one of several that have arrived in the country or originated here, all with the ability to spread faster than other variants.

“The pandemic is a lot more complicated now than it was a couple months ago,” said Dr. Dan Barouch, a virologist at Beth Israel Medical Center in Boston.

Vaughan Cooper, an evolutionary biologist at the University of Pittsburgh, said that all the new variants were likely evolving quietly for months before bursting on the scene. “I think we’re going to see many stories like this,” he said.

Federal regulators are also still waiting on data from Johnson & Johnson’s new manufacturing facility in Baltimore that prove it can mass-produce the vaccine. The company is counting on that factory to help reach its contractual pledge to the federal government of 100 million doses by the end of June.

If Johnson & Johnson can deliver vaccines quickly enough to the United States, it might be able to help drive down cases before variants make things worse. Since the vaccine requires only a single shot — unlike the Moderna and Pfizer-BioNTech vaccines, which require two — that delivery would translate into full coverage for 100 million people.

Johnson & Johnson’s vaccine has another advantage that might help speed up the rollout. It can stay viable in a refrigerator for three months, while the two authorized vaccines have to be kept frozen. That gives the company an edge not just in reaching more isolated parts of the United States, but in getting the vaccine to remote areas of the world that could otherwise seed more aggressive mutants.

“I hope this vaccine gets approved as soon as possible to reduce disease burden around the world,” said Akiko Iwasaki, immunologist at Yale University. She pointed out that the shot greatly reduced the number of severe Covid cases, even those caused by the variant. “This is a really great result.”

Still, Johnson & Johnson and other vaccine makers must prepare for the B.1.351 variant or another one surging to dominance and demanding new vaccines. “You’ve got to be nimble enough to be able to adapt by upgrading our vaccines that match the dominant strain,” Dr. Fauci said.

Exactly when to make that switch will be a difficult decision, because the viruses are spreading unpredictably, and manufacturing new doses will be a huge undertaking.

“The implications of that are big. You would not take that choice lightly,” said John D. Grabenstein, an epidemiologist with the Immunization Action Coalition, a nonprofit organization that disseminates information about vaccines. “It’s not doomsday. It’s just that we are going to need a bigger boat.”

Johnson & Johnson’s announcement came one day after Novavax said an early analysis of its 15,000-person trial in Britain had revealed that the two-dose vaccine had an efficacy rate of nearly 90 percent there. But in a small trial in South Africa, the efficacy rate dropped to just under 50 percent.

Johnson & Johnson presented only a summary of findings of its clinical trial. The vaccine was 85 percent effective in preventing severe disease in all three regions where the trial was run: the United States, Latin America and South Africa. After 28 days, none of the vaccinated participants who developed Covid-19 had to be hospitalized.

The company reported that the vaccine’s protective effect seems to increase with time. But without long-term data on immunity, scientists and regulators do not yet know whether the vaccine’s efficacy peaks at some point before dropping.

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

Am I eligible for the Covid vaccine in my state?

Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area

Is the vaccine free?

You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.

Can I choose which vaccine I get?How long will the vaccine last? Will I need another one next year?

That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.

Will my employer require vaccinations?Where can I find out more?

Dr. Stoffels said the company was still waiting for more data on whether the vaccine can protect against asymptomatic infection.

The company is preparing a lengthy briefing document it will submit to the F.D.A. in its application for authorization. The agency’s scientists will review the raw data from the trial and present their own analysis.

Unlike the messenger RNA vaccines made by Pfizer-BioNTech and Moderna, Johnson & Johnson uses an adenovirus, which normally causes the common cold. While adenovirus-based vaccines have been investigated for some three decades, they have yet to be licensed for use in the United States.

Johnson & Johnson’s Ebola vaccine became the first approved adenovirus-based vaccine for any disease when European regulators gave it the green light last July. Astra-Zeneca and the University of Oxford used a different adenovirus for their coronavirus vaccine, which is now authorized in Britain and other countries. Russian scientists created their Sputnik V vaccine from adenoviruses as well.

Johnson & Johnson received $456 million from Operation Warp Speed to support its research. In July, the government agreed to purchase 100 million doses for $1 billion if it proved safe and effective.

That same month, the company moved into clinical trials, which found that a single shot produced a strong immune response, consistent with experiments done on monkeys. Johnson & Johnson began the final “Phase 3” trial in September, again using a single dose. It recruited volunteers in the United States, South Africa and Latin America.

Half of the volunteers received the vaccine, and half received a placebo. The company then had to wait. Only when enough people in the trial got Covid-19 would an independent board of advisers look at the results to see how many sick volunteers were vaccinated — a process known as unblinding.

Late last year, surges of coronavirus infections accelerated the trial toward unblinding. In December, Johnson & Johnson decided it would not need to recruit 60,000 volunteers as it originally planned. It capped the trial at 45,000.

Like other vaccine developers, Johnson & Johnson was required by the F.D.A. to also record information about adverse events experienced by the volunteers for the first few months after vaccination.

Dr. Barouch, who led the team that designed the vaccine and tested it on animals last year, had to wait for months for the unblinding. “I’m thinking a lot about it,” he said in a Jan. 11 interview. “But, no, I don’t have champagne ready to go.”

After he learned the results, Dr. Barouch said he was delighted. “I think this vaccine will have a public health benefit throughout the world,” he said.

Johnson & Johnson is also moving forward with other trials of the vaccine to see how it can be improved. In December it began a trial with two doses. Dr. Fauci was optimistic that people who get a so-called prime boost may enjoy even more protection.

“If they get a prime boost, it’s entirely conceivable that they can get up to 90-plus percent,” he said.

In addition, Dr. Stoffels said that Johnson & Johnson was tailoring a version of its vaccine with a protein patterned after the B.1.351 variant. It could potentially deploy it in countries where that version of the virus was a threat.

“Pretty much all vaccine developers now are having that conversation,” said Dr. Peter J. Hotez, a vaccine expert with the Baylor School of Medicine and the creator of a different coronavirus vaccine.

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Unwanted effects are indicators shot is constructing safety, says ex-FDA chief

Side effects are signs shot is building protection, says ex-FDA chief

Covid-19 vaccine side effects are signs that the shots are helping to protect against the disease, said former FDA chief Dr. Margaret Hamburg on Thursday opposite CNBC.

“The data tell us that this vaccination produces a fairly routine response at the time of administration, but it is noteworthy when you receive the vaccine,” she said on Squawk Box. “You will know when you will receive the vaccine, but that will also show you that it works and that your body is reacting,” added Hamburg, who headed the regulator in the Obama administration from 2009 to 2015.

The Hamburg statements come when the vaccine committee of the Food and Drug Administration meets on Thursday whether Pfizer and German partner BioNTech should vote for the emergency approval of the Covid-19 candidate. The non-binding decision by the panel of experts is a final step before the FDA is expected to approve the vaccine for limited use.

The agency will meet next week at the request of Massachusetts-based Moderna to obtain the same approval. The vaccine is similar to Pfizer’s in that they both take a new approach that uses genetic material to trigger an immune response.

Pfizer’s vaccine was approved by regulators in the UK last week, where the first shots for non-trial participants were given on Tuesday. However, the two allergic reactions reported by UK health workers prompted UK regulators to advise people with a history of “significant” allergic reactions to abstain from the vaccine for the time being.

Coronavirus vaccine development deadlines have been hastened this year by drug makers and governments alike in hopes of finding a solution to the devastating pandemic that killed at least 1,571,890 people worldwide, according to Johns Hopkins University. The US recorded a record 3,124 deaths on Wednesday.

Both Pfizer’s and Moderna’s vaccines were shown to be more than 94% effective in preventing symptomatic Covid-19, according to data from large-scale clinical trials.

Some of the reported side effects are “local swelling, irritation, pain, fatigue, sometimes headache,” said Hamburg. “A percentage of the patients had chills and a slight fever.”

Dr. Moncef Slaoui, who leads the Trump administration’s vaccine development efforts, has defended the safety of Pfizer and Moderna vaccines. He said earlier this month that “significantly noticeable” side effects from the admissions were reported in only 10% to 15% of study participants, which may lasted up to a day and a half.

Both Pfizer’s and Moderna’s vaccines require two doses. Some doctors have tried to raise awareness of the side effects so that vaccine recipients aren’t deterred from getting the second shot.

“We really need to make patients aware that this is not going to be a walk in the park,” said Dr. Sandra Fryhofer of the American Medical Association in November at an advisory panel meeting of the Centers for Disease Control and Prevention. “You will know you had a vaccine. You probably won’t feel wonderful. But you have to come back for that second dose.”

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Pfizer’s Vaccine Gives Sturdy Safety After First Dose

Pfizer’s Vaccine Offers Strong Protection After First Dose

WASHINGTON – The coronavirus vaccine, manufactured by Pfizer and BioNTech, offers strong protection against Covid-19 within about 10 days of the first dose. This emerges from documents released Tuesday by the Food and Drug Administration ahead of a meeting of their vaccine advisory group.

The result is one of several significant new results in the newsletters, which includes more than 100 pages of data analysis from the Agency and Pfizer. Last month Pfizer and BioNTech announced that their two-dose vaccine had a 95 percent effectiveness rate after two doses three weeks apart. The new analyzes show that protection starts much earlier.

In addition, the vaccine worked well regardless of the race, weight, or age of a volunteer. While no serious adverse events from the vaccine were identified in the study, many participants experienced pain, fever, and other side effects.

“This is what an A + certificate looks like for a vaccine,” said Akiko Iwasaki, an immunologist at Yale University.

On Thursday, the FDA’s Vaccine Advisory Panel will discuss these materials prior to a vote on whether to recommend approval of the vaccine by Pfizer and BioNTech.

Pfizer and BioNTech started a large-scale clinical trial in July that recruited 44,000 people in the US, Brazil and Argentina. Half of the volunteers received the vaccine and half the placebo.

New coronavirus cases in the vaccinated group of volunteers quickly subsided about 10 days after the first dose, according to a graphic in the educational materials. The number of cases increased steadily in the placebo group.

The vaccine’s swift action could benefit not only the people who receive it, but also the strained hospitals in the country, limiting the flow of new patients to intensive care units.

Despite the early protection provided by the first dose, it is unclear how long this protection would last on its own, which underscores the importance of the second dose. Previous studies have shown that the second dose of the Pfizer BioNTech vaccine gives the immune system a significant long-term boost that is seen with many other vaccines.

The effectiveness of the vaccine after the first dose, according to Dr. William C. Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, at about 52 percent. After the second dose, this value increases to about 95 percent. “Two doses of the vaccine offer maximum protection,” he said.

Many experts have raised concerns that the coronavirus vaccines might protect some people better than others. However, the results in the educational materials indicate no such problem. The vaccine has a high rate of effectiveness in both men and women, and similar rates in whites, blacks, and Latinos. It also worked well on obese people who are at higher risk of developing Covid-19.

Some vaccines for other diseases produce a weak immune response in older adults. However, Pfizer and BioNTech found that people over 65 received about as much protection from the coronavirus vaccine as younger people.

“I’ve never seen anything like it,” said Dr. Gregory Poland, a vaccine researcher at the Mayo Clinic, on the vaccine’s robust response in the overweight and elderly.

Even if the vaccine is approved by the FDA, the study will continue. In the briefing documents, the companies said they would encourage people to stay in the study for as long as possible without knowing whether they received the vaccine or the placebo, so the researchers can continue to gather information on whether the vaccine is safe and effective.

The road to a coronavirus vaccine

Interesting facts about vaccines

Confused by all of the technical terms used to describe how vaccines work and study? Let us help:

    • Adverse event: A health problem that occurs in volunteers in a clinical trial with a vaccine or drug. An adverse event is not always caused by the treatment tested in the study.
    • Antibody: A protein produced by the immune system that can attach to a pathogen such as the coronavirus and prevent it from infecting cells.
    • Approval, Licensing, and Approval for Emergency Use: Medicines, vaccines and medical devices cannot be sold in the US for no profit approval by the Food and Drug Administration, also known as Licensing. After a company submits the results of clinical studies to the FDA for review, the agency decides whether the product is safe and effective. This process usually takes many months. If the country faces an emergency – like a pandemic – a company can file an application instead Emergency approvalthat can be granted much faster.
    • Background rate: How often does the general population experience a health problem called an Adverse Event? To determine whether a vaccine or drug is safe, researchers compare the rate of adverse events in one study to the background rate.
    • Effectiveness: The benefit of a vaccine compared to a placebo, measured in a clinical trial. For example, to test a coronavirus vaccine, the researchers compare how many people in the vaccinated group and the placebo group are receiving Covid-19. In contrast, effectiveness is the benefit that a vaccine or drug offers in the real world. A vaccine’s effectiveness can be found to be less or more effective than its effectiveness.
    • Phases 1, 2 and 3 studies: Clinical trials typically take place in three phases. Phase 1 studies typically involve a few dozen people to determine whether a vaccine or drug is safe. In Phase 2 trials that involve hundreds of people, researchers can try different doses and take more measurements of the vaccine’s effects on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of the vaccine or medicine by waiting to see how many people are protected from the disease it is intended to be used against.
    • Placebo: A substance with no therapeutic effect that is widely used in clinical trials. For example, to see if a vaccine can prevent Covid-19, researchers can inject the vaccine into half of their volunteers while the other half are given a placebo with salt water. You can then compare how many people are infected in each group.
    • Post-market surveillance: The surveillance that occurs after a vaccine or drug has been approved and regularly prescribed by doctors. This monitoring usually confirms that the treatment is safe. Rarely, side effects are noted in certain groups of people that were overlooked during clinical trials.
    • Preclinical Research: Studies that take place prior to the start of a clinical trial typically include experiments that test a treatment on cells or animals.
    • Viral vector vaccines: A type of vaccine that uses a harmless virus to deliver immune-stimulating ingredients into the human body. Viral vectors are used in several experimental Covid-19 vaccines, including those developed by AstraZeneca and Johnson & Johnson. Both companies use a cold virus called adenovirus as a vector. The adenovirus carries coronavirus genes.
    • Test protocol: A series of procedures that must be performed during a clinical trial.

The educational materials also provide a deeper look into the safety of the vaccine. In any large clinical trial, some people who receive vaccines have health conditions unrelated to the vaccine itself. Comparing their symptom rates with those of the placebo group, as well as background rates in a population, may indicate symptoms that a vaccine may actually cause.

The FDA concluded that there were no “significant imbalances” between the two groups in serious health complications known as adverse events. The agency found that four people in the vaccinated group had a form of facial paralysis called Bell’s palsy, with no cases in the placebo group. The difference between the two groups was not significant and the rate in the vaccinated group was not significantly higher than in the general population.

The new Pfizer analysis found that many volunteers who received the vaccine felt sick in the hours after the second dose, suggesting that many people may need to request a day off or be willing to rest until symptoms appear ease up. Among the 16 to 55 year olds, more than half developed fatigue and more than half also reported headaches. Slightly more than a third experienced chills and 37 percent had muscle pain. About half of those over 55 felt tired, a third had a headache, and about a quarter felt chills, while 29 percent had muscle pain.

“Taking a day off after the second dose is a good thing to anticipate,” said Dr. Iwasaki.

On Monday, Kristen Choi, a psychiatric nurse and health care researcher at the University of California at Los Angeles, released a firsthand report on the symptoms she experienced as a participant in the Pfizer BioNTech study, including chills, nausea and headaches and fever.

“Doctors need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could be very similar to Covid-19,” wrote Dr. Choi in JAMA Internal Medicine. She advised doctors to tell patients that these uncomfortable symptoms “are a sign that the vaccine is working despite the unfortunate similarities with the symptoms of the disease”.