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In Covid-19 Vaccine Information, LGBTQ Folks Worry Invisibility

Even if some people are reluctant to reveal such data, research shows that clinicians overestimate how many patients would refuse to self-report. A 2017 study found that around 80 percent of doctors felt that patients would be reluctant to provide this data, but only 10 percent of patients said they would refuse to do so.

The Centers for Disease Control and Prevention have also stated that it should be optional for patients to report their gender identity. The ability to report yourself is key, according to proponents. “It’s important that people identify like any other demographic,” said Chris Grasso, vice president of information technology and data services at the Fenway Institute. “We want to normalize data collection – just like we ask people questions about their age, race, or ethnicity.”

LGBTQ advocates have been raising alarm bells throughout the pandemic, writing letters to health organizations and the new government, and asking authorities to report on coronavirus testing, care outcomes and vaccine intake in their communities.

Some states and jurisdictions have started moving forward: Pennsylvania, Rhode Island, and Washington, DC are collecting and reporting some of this data in their Covid-19 monitoring systems. And in September, the Governor of California signed a bill requiring healthcare providers to collect the data for all communicable diseases.

But it wasn’t until March that the California Department of Health hadn’t released its sexual orientation and gender identity statistics. And other officials raising concerns from those trying to keep their sexuality private have expressed concern about the gathering of this information. For example, Colorado Governor Jared Polis, who is gay, said in a discussion with other elected officials in April 2020, “There are a lot of people in Colorado who don’t want this information out there.”

Despite the lack of data, the CDC notes that LGBTQ people may have more severe Covid-19 results than heterosexual people, in part due to a higher prevalence of pre-existing conditions such as heart disease, diabetes, asthma, cancer, obesity and smoking .

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Biden-backed Covid vaccine patent waiver will trigger issues

Sergeant Jennifer Callender (L) of the Illinois Air National Guard administers a vaccine for Pfizer Covid-19 to Virginia Persha on February 3, 2021 at a vaccination center at Triton College in River Grove, Ill.

Kamil Krzaczynski | AFP | Getty Images

Pfizer CEO Albert Bourla warned on Friday that waiving patent protection for Covid vaccines – a proposal just endorsed by President Joe Biden – would spark a global race for raw materials that would allow the safe and efficient manufacture of Covid- Shots at risk.

The Biden government said Wednesday it supports the limited intellectual property rule waiver in the service of expanding vaccine distribution to the lower-income countries currently hit by the pandemic.

But Bourla, whose company makes one of three vaccines approved for use in the United States, “categorically” believes the waiver will “cause more problems.”

“Right now, the infrastructure is not the bottleneck for us to produce faster,” wrote Bourla in a letter from a dear colleague published on LinkedIn. “The limitation is the lack of highly specialized raw materials needed to make our vaccine.”

Pfizer’s vaccine requires 280 different materials and components, sourced from 19 countries around the world, Bourla said. He claimed that companies with much less experience than Pfizer would compete for the same ingredients in making vaccines without patent protection.

“Currently, virtually every gram of the raw material produced is immediately delivered to our manufacturing facilities and is instantly and reliably switched to vaccines that are immediately shipped around the world,” wrote Bourla.

He predicted that the proposed waiver “threatens to disrupt the flow of raw materials”.

Albert Bourla, CEO of Pfizer, speaks after attending a press conference to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the factory of the US pharmaceutical company Pfizer in Puurs, Belgium, on April 23, 2021.

John Thys | Pool | Reuters

“It will create a mess for the critical inputs we need to make a safe and effective vaccine,” wrote Bourla.

“Companies with little or no vaccine manufacturing experience are likely hunting the very raw materials we need to scale our production, putting everyone’s safety at risk,” the CEO wrote.

The White House referred CNBC’s reach to Bourla’s post to the US sales representative’s office, which did not immediately respond to a request for comment.

The leaders of the World Trade Organization recently called on member states to reach an agreement on possible waivers for vaccination patents. But even with the support of the US, an agreement is hardly guaranteed, since the decisions of the WTO are based on consensus and require the consent of all 164 members.

Germany, a WTO member and the largest economy in Europe, spoke out against the waiver proposal on Thursday. BioNTech, which worked with Pfizer to develop the vaccine, is based in Germany.

Bourla on LinkedIn also expressed concern that potential vaccination waivers “will discourage others from taking great risks”.

“The latest rhetoric isn’t going to stop us from continuing to invest in science. However, I’m not sure if the same is true of the thousands of tiny biotech innovators who are totally dependent on access to capital from investors who just do investing provided their intellectual property is protected, “wrote the CEO.

PhRMA, the pharmaceutical industry advocacy group that includes Pfizer and Johnson & Johnson, another US vaccine company, described the waiver as “an unprecedented move that will undermine our global response to the pandemic and put safety at risk”.

Meanwhile, Moderna CEO Stephane Bancel, maker of the other U.S.-approved Covid shot, said he wasn’t concerned about the possible exemptions.

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China’s Sinopharm Vaccine Authorised for Emergency Use By W.H.O.

Developing countries looking for coronavirus vaccines now have another reliable option – and China’s reputation as an emerging scientific superpower has just gotten a big boost.

The World Health Organization on Friday declared a vaccine from the Chinese company Sinopharm as a safe and reliable way to fight the virus. The statement marks a significant step in dispelling doubts about the vaccine after the Chinese government and company released little data on late-stage clinical trials.

WHO emergency approval enables Sinopharm vaccine to be included in Covax, a global initiative to provide free vaccines to poor countries. The possible inclusion in Covax raises the hope that more people – especially in developing countries – will have access to recordings at a crucial moment.

Rich countries hoard vaccine doses. India, a major vaccine maker, has stopped exporting to deal with the deepening coronavirus crisis. Safety concerns led health authorities in some countries to temporarily stop using AstraZeneca and Johnson & Johnson vaccines.

“The addition of this vaccine has the potential to quickly accelerate access to Covid-19 vaccines for countries that want to protect health workers and vulnerable populations,” said Dr. Mariângela Simão, WHO Deputy Director General for Access to Health Products, in a statement.

Reliable access to vaccines could improve even further next week if WHO considers another Chinese shot from a company called Sinovac. But the fanfare can be short-lived. While China has claimed it could produce up to five billion cans by the end of this year, Chinese officials say they are struggling to make enough cans for their own people and are warning a pandemic-weary world to keep expectations in check .

“This should be the golden time for China to practice vaccine diplomacy. The problem is also that China itself is facing a shortage, ”said Yanzhong Huang, Senior Fellow on Global Health at the Council on Foreign Relations. “In terms of global access to vaccines, I don’t expect the situation to improve significantly in the next two to three months.”

China’s vaccination campaign got off to a slow start, partly because the government gave export priority and residents did not feel rushed to get vaccinated. The country is now accelerating its national vaccination campaign and aims to vaccinate 40 percent of its 1.4 billion people by the end of June.

Sinopharm and Sinovac are producing about 12 million doses a day, slightly more than the 10 million doses China plans to give daily to meet the domestic target. According to a calculation on data from Bridge Consulting, a Beijing-based consultancy focused on China’s impact on global health, companies would have to produce around 500 million additional doses to meet other countries’ demands.

The vaccine shortage in China underscores the complexity of launching a mass vaccination campaign for the world’s most populous nation and attempting an ambitious export program. Companies involved in the vaccine supply chain, such as syringe manufacturers, work overtime.

Updated

May 7, 2021, 2:53 p.m. ET

“This vaccine is lacking all over the world,” said Pearson Liu, a Sinovac spokesman. “The demand is just too great.”

To make up for the deficit, Chinese officials said those who get vaccinated in China could delay the second shot for up to eight weeks or combine the same type of vaccine from different companies. You said the shortage should subside by June.

Andrea Taylor, who analyzes global data on vaccines at the Duke Global Health Institute, described the possible inclusion of two Chinese vaccines in the Covax program as a “game changer”.

“The current situation is so desperate for low- and lower-middle-income countries that it is worth mobilizing all the doses we can get out of it,” said Ms. Taylor. “Possibly having two options from China could really change the landscape of the possible in the next few months.”

China’s vaccines have been launched in more than 80 countries, but have met with considerable skepticism, partly because the companies have not released data on phase 3 clinical trials to allow scientists to independently evaluate vaccine efficacy rates. A WHO advisory group released the data this week.

According to the WHO advisory group, the Sinopharm vaccine developed with the Beijing Institute of Biological Products has an effectiveness rate of 78.1 percent. The Sinovac vaccine has different efficacy rates between 50 and 84 percent depending on the country in which phase 3 studies were conducted. Both vaccines are made using a proven technology that uses chemicals to weaken or kill a virus.

The advisory group’s data showed that the Sinopharm vaccine had a “high level of confidence” in preventing Covid-19 in adults, but a “low confidence” for people over 60. The group’s results were for the Sinovac vaccine similar .

The WHO said that Sinopharm could not estimate the effectiveness of the vaccine for this group because Sinopharm had only included a few adults over 60 years of age in its studies. However, WHO said it would not restrict use of the vaccine in this age group, as preliminary data suggests that “the vaccine is likely to have protective effects in the elderly”.

There is limited data on how well the vaccine works against the many coronavirus variants that are found around the world. Chinese vaccines are overall less effective than those manufactured by Pfizer-BioNTech and Moderna.

But for China’s leaders, WHO’s approval can still be seen as a badge of honor. Xi Jinping, China’s leader, is committed to making a Covid-19 vaccine a “global public good.”

After India announced export restrictions on vaccines last month, Indonesia and the Philippines said they would turn to China for help. Last week, China’s foreign minister offered to give South Asian countries access to vaccines.

Indonesia said it would receive additional doses of Sinovac after President Joko Widodo held talks with Mr. Xi. In a speech that same week, President Rodrigo Duterte of the Philippines said he owed China “gratitude” for its vaccines.

It remains to be seen whether WHO’s approval will change Beijing’s approach to vaccine distribution. China has only given Covax 10 million doses, despite having independently donated 16.5 million doses and sold 691 million doses to 84 countries, according to Bridge Consulting. Many of the donations went to developing countries in Africa and Asia.

“They don’t like to have their generosity in their products under one UN brand,” said J. Stephen Morrison, director of the global center for health policy at the Center for Strategic and International Studies. “You are in a historic phase,” he said. “They want recipients to know this is China delivering.”

Jason Gutierrez contributed to the coverage. Elsie Chen contributed to reporting and research.

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WHO approves Covid vaccine made by China’s Sinopharm for emergency use

On April 24, 2021, workers at Damascus International Airport in the Syrian capital unloaded boxes of the Sinopharm Covid-19 vaccine donated by China.

Loua Beshara | AFP | Getty Images

The World Health Organization announced on Friday that it had approved an emergency coronavirus vaccine developed by the Chinese state-owned pharmaceutical company Sinopharm.

Beijing’s Covid vaccine is recommended for adults aged 18 and over with a double dose, WHO Director General Tedros Adhanom Ghebreyesus said at a press conference.

The new addition to the list of usable vaccine options could accelerate efforts to control the spread of Covid-19 and its variant forms, which are causing new infections in many parts of the world.

“To solve the vaccine crisis, we have to pull out all the stops,” said Tedros.

Sinopharm’s shot is the sixth to receive WHO approval for “safety, efficacy and quality,” he said.

“Vaccines remain an important tool. However, at the moment, the volume and distribution of vaccines is insufficient to end the pandemic without the sustained and tailored application of public health measures that we know work,” said Tedros.

“The pandemic has shown that everything is at risk when health is at risk. When health is protected and promoted, individuals, families, communities, economies and nations can thrive,” he said.

The state-owned drug manufacturer’s two-dose Covid shot has already been approved for emergencies in China, the United Arab Emirates and Bahrain.

Another Chinese shot by the private company Sinovac has not yet been approved by the WHO.

In the US, vaccines developed by Pfizer-BioNTech, Moderna, and Johnson & Johnson have received emergency approval from the Food and Drug Administration.

WHO has granted emergency validation for these three shots as well as vaccines made by Astrazeneca-SK BIO and the Serum Institute of India.

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Confidence within the security of the J&J vaccine is low following U.S. pause, Kaiser survey reveals

An Army nurse holds a vial of the Johnson & Johnson vaccine at the FEMA-sponsored COVID-19 vaccination site at Valencia State College on the first day the site provided the Johnson & Johnson vaccine after the FDA repealed The CDC has offered a break again due to blood clot concerns.

Paul Hennessy | LightRocket | Getty Images

According to a new survey by the Kaiser Family Foundation, less than half of Americans believe the Johnson & Johnson Covid-19 vaccine is safe after it was temporarily suspended in the US after reports of rare blood clotting problems in some recipients.

While most people believe in Covid vaccines, in general, only 46% of respondents said they were at least somewhat confident about the J&J inclusion, compared to 69% who were for both Pfizer and the Moderna vaccines said. Kaiser surveyed 2,097 randomly selected adults aged 18 and over from April 15 to 29 for the study published on Wednesday.

The Food and Drug Administration and Centers for Disease Control and Prevention urged states on April 13 to temporarily stop using J & J’s vaccine “out of caution” after six women reported rare blood clots. A CDC panel recommended the US resume the vaccine ten days later, saying the benefits outweigh the risks.

The J&J news seems to have changed some opinions about a shot.

One in five non-vaccinated respondents said the news changed their minds about receiving the vaccine, even though the specific responses were different. 7% said they were less likely to want any of the three Covid vaccines, Kaiser noted. Another 9% said they were less likely to want the J&J vaccine, but that it didn’t change their mind about the Pfizer or Moderna shots.

Nevertheless, the proportion of respondents who said they had received a shot rose significantly from 32% to 56% in the survey last month. That number reflects data from the CDC, which reports that roughly the same proportion of adults in the United States have received one or more doses.

“The news was widespread and it certainly hurt confidence in J&J, but it’s not clear that it had much of an impact on whether or not people were actually vaccinated,” said Dr. Mollyann Brodie, General Manager of Public Opinion and Survey Research at the Foundation Program. “It confirmed for people who were concerned about side effects that there were side effects, but we know that the immediate effect – at least in terms of what people told us – is very small in terms of demand.”

Women were more likely than men to say the J&J news had changed their minds about vaccination. The Kaiser survey found that Hispanic women in particular, 18% of whom said they were less likely to want a vaccine at all.

The timing of the Johnson & Johnson hiatus coincides with a general slowdown in US vaccinations. The country reported an average of 2.1 million vaccinations per day for the past week, CDC data shows, up from a high of 3.4 million on April 13.

The fact that the nationwide drop in daily shots occurred during the stop is more a coincidence than a direct effect, said Dr. Rupali Limaye, faculty member at the Johns Hopkins Bloomberg School of Public Health. Limaye is researching vaccine decision-making and has worked with state health departments during the vaccine launch.

While the hiatus at J&J, and the reluctance it caused, contributed somewhat to the decline, the bigger factor, according to Limaye, is that the country has reached the point where most Americans who want a vaccine have got one.

“I hear from states that not only are things slowing down generally because of J&J, but also slowing down because we have essentially been able to meet the demand,” she said.

The survey data from the Kaiser Foundation confirm this. Respondents who said they were most anxious to get a shot – those who have already been vaccinated or want it as soon as possible – rose only marginally from 61% to 64% in the previous survey in March. The proportion who wanted to “wait and see” before vaccination, who had lost in size, remained roughly the same.

“We are at a stage in the vaccination effort where all the eager people are vaccinated or are about to be vaccinated,” said Brodie. “We are now turning to the reluctant people, with strategies that are required to reach many different people.”

This equates to an 87% decline, which is steeper than the declines Pfizer and Moderna saw from their respective peaks.

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Pfizer and BioNTech start the method of searching for full U.S. approval for his or her Covid vaccine

Vials containing the Pfizer-BioNTech Covid-19 vaccine on Thursday, February 11, 2021 at the vaccination site of the Sun City Anthem Community Center in Henderson, Nevada, USA.

Roger Kisby | Bloomberg | Getty Images

Pfizer and German drug maker BioNTech announced that they have begun filing for full approval of their Covid-19 vaccine for people aged 16 and over in the United States. This makes the companies the first in the nation to apply for full regulatory approval.

The Food and Drug Administration issued emergency approval for their Covid vaccine at the end of December. Since then, Pfizer has distributed 170 million doses in the US, with the goal of having 300 million doses by the end of July.

“We are proud of the tremendous progress we have made in working with the US government to deliver vaccines to millions of Americans since December,” said Albert Bourla, Pfizer CEO, in a statement. “We look forward to working with the FDA to complete this ongoing filing and support its review with the aim of ensuring full regulatory approval for the vaccine in the months ahead.”

Pfizer needs to demonstrate that it can reliably manufacture the vaccines in order to get full clearance. If approved, companies could market their shots directly to consumers and potentially change the pricing of the cans. It also allows the shot to stay in the market once the pandemic is over and the US is no longer considered an “emergency”.

It usually takes the FDA about a year or more to determine whether a drug is safe and effective for the general public. Due to the once in a century pandemic that killed nearly 600,000 people in the United States, the FDA allowed the gunshots to be used as part of an emergency clearance.

The permit grants conditional approval based on data for two months. It’s not the same as a biological license application that requires six months of data and ensures full approval. Companies apply for approval on a “rolling filing” basis, which speeds the review process by allowing the FDA to review new data as soon as the company receives it.

“The BLA filing is an important cornerstone in achieving long-term herd immunity and future COVID-19 containment,” said Dr. Ugur Sahin, CEO and Co-Founder of BioNTech, in a statement. “We are excited to be working with US regulators to apply for approval of our COVID-19 vaccine based on our key Phase 3 study and follow-up data.”

Early data from 12,000 vaccinated people aged 16 and over in this Phase 3 study showed that the shots were 91.3% effective at getting the disease up for up to six months after the second dose and 95.3% effective against severe Covid as defined by the FDA. The companies said on April 1st. The data also showed “a favorable safety and tolerability profile,” they said at the time.

The companies are awaiting FDA emergency approval to use their vaccine in children ages 12-15 and intend to apply for a full license once they have six months of data.

They said in late March that the vaccine was 100% effective in a clinical study involving more than 2,000 adolescents. They also said the vaccine produced a “robust” antibody response in the children that outperformed that in a previous study in older teenagers and young adults. The side effects were generally consistent with those seen in adults, they added.

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Need a Coronavirus Vaccine? U.S. Pharmacies Say Stroll Proper In

Just a few weeks ago, people were sneaking across state lines, designing websites to search the internet, and even trying to pay for coronavirus vaccination appointments.

In much of the US, getting vaccinated can be as simple as entering a pharmacy.

Earlier this week, President Biden urged pharmacies to provide walk-in vaccinations to encourage reluctant people to get the shot. He also announced a new federal website and phone number that will help people find the website that is closest to them.

“We’re going to make it easier than ever to get vaccinated,” Biden said on Tuesday.

Chains like Walmart, Walgreens, Safeway, and Stop & Shop have announced that they are now offering vaccinations for walk-in customers in some locations or in mobile clinics. Other pharmacies preceded the president’s announcement. Rite Aid said there would be a limited number of walk-ins last week, for example. Biden’s administration is expanding access to meet its goal of getting at least the first shot at 70 percent of American adults by July 4th.

Many of the chains qualified the offer and found that walk-ins are subject to availability and that it is better to make an appointment on the same day as well.

Federal health officials have also ordered drug stores and grocery pharmacies to offer second doses of the vaccine to people who received their first shot from another provider.

The Biden government is hoping for a surge in vaccinations before the Food and Drug Administration expects the Pfizer BioNTech vaccine to be approved for adolescents ages 12-15 early next week. The president has said age group is important in the fight against the virus because, while adolescents are not as susceptible to serious illnesses, they can still get sick and infect others.

Convenience isn’t the only way officials have encouraged people to get vaccinated. In exchange for a free vaccination against a potentially fatal disease, you can now get a ticket to a baseball game, a stiff drink, or $ 100.

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Covid vaccine makers’ shares seesaw after U.S. says it would again patent waivers

A healthcare worker fills a syringe with the Moderna COVID-19 vaccine. At the Giorgio Companies site in Blandon, PA where the CATE Mobile Vaccination Unit was on site to deliver Moderna COVID-19 vaccines to workers on Wednesday morning April 14, 2021.

Ben Hasty | MediaNews Group | Getty Images

Stocks of two Covid vaccine makers fluctuated Thursday after the Biden government announced it would support a motion before the World Trade Organization to forego patent protection for the mRNA technology used to manufacture the vaccines.

Pfizer was down as much as 5% on Thursday from Wednesday’s close of trading, while Moderna fell nearly 12% before both stocks made up for most of those losses. The companies use the same mRNA technology to make their recordings.

Pfizer, which makes its Covid-19 vaccine with German pharmaceutical company BioNTech, closed about 1% that day, while Moderna lost about 1.4% that day.

South Africa and India are urging US officials and the WTO to temporarily forego patent protection so developing countries can manufacture life-saving vaccines until world leaders can bring the pandemic under control. Human rights organizations such as Doctors Without Borders, Oxfam and Amnesty International have all signed letters in support of the proposal.

US sales representative Katherine Tai released a statement Wednesday evening in support of the waiver.

“This is a global health crisis and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” she said. “The government firmly believes that protecting intellectual property, but in the service of ending this pandemic, supports the removal of this protection for COVID-19 vaccines.”

Moderna CEO Stephane Bancel told investors on a earnings call Thursday that he had “not lost a minute of sleep” on the news and said traders’ concerns were false.

Johnson & Johnson and AstraZeneca both use an adenovirus, a common type of virus that typically causes mild cold symptoms, to make their Covid vaccines. The stocks of these two companies barely changed on Thursday.

President Joe Biden made an election promise last year to “absolutely positively” renounce vaccination patents. The waiver of patent protection can take months or even years.

Critics of the move say that developing countries do not have the infrastructure to produce the vaccines, others disagree.

Analysts largely shook off the news.

“We believe a new manufacturing operation can take 6 to 9 months to scale up, effectively limiting the impact of other manufacturers. While we expect the headlines to put pressure on MRNA, we don’t see any significant practical impact from this news,” said the Morgan Stanley analysts said in a research report Thursday.

Bank of America analysts cited “obstacles to vaccine development, including sourcing raw materials, developing manufacturing and engineering know-how.” They also note that “US support does not mean approval when WTO decisions require consensus and other members such as the EU, UK, Japan and Switzerland are currently opposed to surrendering intellectual property.”

The German Chancellor Angela Merkel spoke out against the exemptions together with these countries on Thursday. “The limiting factor in the manufacture of vaccines is the production capacity and high quality standards, not the patents,” a Merkel spokeswoman said in a statement.

The President of the European Commission, Ursula von der Leyen, did not accept the waiver plan and stated in a speech that she was “ready to discuss proposals that would address the crisis in an effective and pragmatic way”.

Both Pfizer and Moderna already have plans to produce billions of cans in the meantime, leaving essentially all competitors far behind in the manufacturing process.

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Pfizer Vaccine Is Extremely Efficient In opposition to Variants, Research Discover

The second new study, published in The Lancet, was carried out by researchers from the Israel Ministry of Health and Pfizer. It is based on more than 230,000 coronavirus infections that occurred in Israel between January 24th and April 3rd. During that period, B.1.1.7 accounted for nearly 95 percent of all coronavirus cases in the country, with more than half of which vaccinated its population.

The researchers found that the vaccine was more than 95 percent effective against coronavirus infections, hospitalizations, and deaths in people aged 16 and over who were fully vaccinated. It also worked well in older adults. Among those 85 years old or older, the vaccine was more than 94 percent effective against infection, hospitalization, and death.

As the percentage of people fully vaccinated increased in each age group, the incidence of coronavirus infections decreased in this cohort, the researchers found. The decline in infection rates was more in line with the timing of increases in vaccine coverage in each age group than the start of a nationwide lockdown. The results suggest that Israel’s rapid pace of vaccination was responsible for the decline in infections in the country.

“I’m just so happy to see this data that these vaccines have such an amazing impact on controlling infection and disease in the real world,” said Akiko Iwasaki, an immunologist at Yale University.

Both studies also reported that two doses of the vaccine provided significantly more protection than one dose. For example, in the Israel study, one dose of the vaccine was 77 percent effective against death, while two doses were 96.7 percent effective.

“It absolutely underscores the need for the second dose,” said Dr. Kathleen Neuzil, who directs the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine.

Taken together, the studies suggest that vaccination remains a plausible way out of the pandemic even with the new variants, experts said. “If we can get vaccines out into the world and improve reporting,” said Dr. Neuzil, “I believe that we can go beyond that and stay up to date on the emergence of new variants.”

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Moderna says vaccine generates promising immune response in opposition to variants

A doctor draws a syringe of Moderna’s vaccine.

Oliver Berg | Image Alliance | Getty Images

A booster of Moderna’s Covid-19 vaccine triggered a promising immune response against variants B.1.351 and P.1, which were first identified in South Africa and Brazil, respectively, the company announced on Wednesday, citing early data from an ongoing clinical study.

In the study, Moderna is testing a 50 microgram dose of its vaccine in previously vaccinated people. The booster dose was found to increase neutralizing antibody responses against the original virus, as well as against B.1.351 and P.1, two variants that have since spread to other countries, including the United States

The company also said that a booster shot of its other vaccine, which it calls mRNA-1273.351, produced an even better immune response over its current vaccine against the B.1.351 variant from South Africa. The new vaccine is a variant-specific booster shot that targets B.1.351.

The preliminary results, which Moderna says will be published online, have not yet been peer-reviewed.

“As we seek to defeat the ongoing pandemic, we continue to seek to be proactive as the virus evolves,” said Stephane Bancel, CEO of Moderna, in a press release. “We are encouraged by this new data, which increases our confidence that our booster strategy should protect against these newly discovered variants.”

According to Moderna, the side effects were similar to those seen after the second dose of the vaccine in the previously reported studies. Side effects included injection site pain, fatigue and headache, and muscle and joint pain.

The new data comes as drug makers and scientists now say people will likely need a booster shot of Covid-19 vaccines and possibly additional shots each year, just like they did with seasonal flu.

Moderna’s vaccine requires two doses four weeks apart. As with Pfizer and Johnson & Johnson, the shot against Covid is very effective, although company executives and officials now say they expect this strong protection to wear off over time. Pfizer’s vaccine is also a two-dose therapy, while the J&J immunization is just one burst.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, previously said that Americans may need booster vaccinations to better protect themselves from variants.

Earlier Wednesday, US health officials said highly contagious variants are still a “wild card” in their nationwide campaign to vaccinate most American adults by July 4th.

A report by the Centers for Disease Control and Prevention published on Wednesday predicted that Covid-19 cases will increase until May due to the highly contagious variant B.1.1.7 first identified in the UK, before declining sharply by July, because vaccinations reduce infections. Still, variants threaten to reverse the nation’s progress, officials said,

“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 a Covid press conference at the White House.

Moderna is evaluating three approaches to increasing immunity. The first approach would use variant-specific booster vaccinations such as mRNA-1273.351, but at a lower dose than the original vaccine. The second would combine the original vaccine with a variant-specific vaccine into a single shot at 50 micrograms or less, Moderna said. The third would test a third shot of the original vaccine at a lower dose.

Bancel told CNBC last month that the company is hoping to have a booster shot for its two-dose vaccine in the fall.