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A COVID-19 pill could soon fill a gap in our pandemic response that vaccines can’t overcome

Pills photo stylized 3
  • Companies are racing to develop a pill that can treat COVID-19.
  • Merck has been the first company to announce successful trial results, but more are on their way.
  • An effective, easy-to-take treatment could play a big role alongside vaccines.
  • See more stories on Insider's business page.

Another COVID-19 breakthrough could be just weeks away, but this time with pills instead of shots.

Two large drugmakers - Pfizer, and Roche - are anticipating late-stage-trial results before the end of the year for experimental antiviral drugs. Merck said Friday that its antiviral pill reduced hospitalization and death, and the company plans to ask the FDA for emergency authorization right away. If successful, these treatments could fill a gap not covered by vaccines: helping already infected people recover faster. They might even be able to stop people from getting sick in the first place.

These oral drugs could change how doctors treat mild and moderate COVID-19 cases and "lower people's risk perception of the pandemic," Matthew Harrison, a Morgan Stanley biotech analyst, wrote in a September 27 research note.

While excitement is building as the pharmaceutical giants launch more studies, don't expect a miracle cure. If these antivirals do work and are safe - which remains to be seen - they're likely to help only in certain circumstances. Scientists working on these drugs say they likely will work best as an early treatment, meaning they won't be of much use to people who are seriously ill.

A simpler, cheaper treatment

COVID-19 pills are an enticing prospect. They're simpler to mass-produce and administer, compared with antibody drugs OK'd to treat COVID-19. The antibody therapies are typically given as an hourlong IV infusion, followed by another hour of monitoring for side effects. The three leading antiviral programs are being tested as 10-pill regimens: two capsules every 12 hours over five days.

The pills are also likely to be cheaper than the antibody infusions, which are free for patients but cost the US government more than $1,000 per dose.

These new drugs could complement vaccines. While the vaccines are highly protective, they also have their limitations. A fraction of people simply refuse to be immunized. Some who get the shot, like those with serious immune-system weaknesses, fail to mount an immune response from the vaccine. And uncertainty lingers for everyone over how well the vaccines stop transmission, as well as how long protection lasts, particularly as the virus keeps mutating.

"We still don't understand how the continued viral evolution is going to impact vaccine efficacy broadly," said Daria Hazuda, the vice president of infectious-disease discovery at Merck who is leading research on a COVID-19 pill. "There's still an important role for antivirals."

Antivirals would be "one more piece of the larger puzzle of solving the COVID problem," said Bernadette Boden-Albala, the director of the public-health program University of California, Irvine, who is not involved with the research.

But Boden-Albala said she was worried the public-health system wouldn't be equipped with widely available rapid testing and an easy way to quickly write and dispense prescriptions for the millions of patients in the US with the virus. The Biden administration isn't working fast enough to build that system now to take full advantage of these drugs if they do work, she said.

"We just have to get the process right - that's been our problem," Boden-Albala said. "We have significant process problems, and the public-health infrastructure is so fragile and needs to be rebuilt."

Merck, Pfizer, and Roche lead the race for a COVID-19 pill

Capsules of molnupiravir, an antiviral drug developed by Merck and Ridgeback Biotherapeutics that could treat COVID-19
Molnupiravir is an experimental oral antiviral developed by Merck and Ridgeback Biotherapeutics that could treat COVID-19.

On Friday, Merck announced that interim study results found its antiviral pill halved the risk of hospitalization or death from COVID-19. The company said it plans to ask the FDA for emergency authorization for the pill "as soon as possible."

The New Jersey pharma is developing an antiviral called molnupiravir, which was originally developed as a treatment for the flu. The company licensed the drug in July 2020 from Ridgeback Biotherapeutics, a small Miami biotech. The federal government is betting big on molnupiravir, agreeing in June to buy enough pills to treat 1.7 million people. That $1.2 billion deal is contingent on the Food and Drug Administration authorizing the treatment.

Merck is finishing a study with 1,850 volunteers with mild or moderate COVID-19 who randomly receive molnupiravir or placebo pills. The main goal is to see if fewer patients on molnupiravir are hospitalized or die after 29 days compared with those getting the placebo.

In general, antivirals launch a war against the virus inside our cells. Viruses hijack our cells and convert them into copying machines. Antivirals try to block that replication process. Drugs like molnupiravir, called nucleosides, intentionally insert errors into the copying process, obstructing the virus' quest to replicate.

That process also means antivirals typically are most potent when given earlier on, when replication is limited. In April, Merck stopped researching its drug in hospitalized COVID-19 patients, saying interim data suggested it didn't help those patients.

The Swiss drugmaking giant Roche is also developing a nucleoside called AT-527 with a small Boston biotech called Atea Pharmaceuticals. This drug was being researched as a hepatitis C antiviral before the pandemic broke out. Preliminary results announced in June from a smaller clinical study showed potential for the drug, but upcoming data will be more definitive. Roche expects results before year-end from a study testing AT-527 against a placebo in 1,386 people with mild or moderate COVID-19.

Roche Pharmaceuticals CEO Bill Anderson thinks oral antivirals are the most promising treatments in the industry's pipeline, he said at a September 7 press briefing. Roche's anti-inflammatory drug Actemra, which is authorized in the US to treat hospitalized COVID-19 patients, helps only when patients face severe illness and are struggling to breathe, Anderson said.

"You really want to be able to treat people before they get so sick," he said.

Finally, there's Pfizer's antiviral program, which acts slightly differently by blocking a protease enzyme that plays a key role in the virus' copying process. Pfizer is testing this antiviral in combination with a low dose of ritonavir, another antiviral that slows the breakdown of Pfizer's drug so it lasts longer in the body.

In July, Pfizer started a 3,000-volunteer study of nonhospitalized COVID-19 patients, hoping to reduce the hospitalization and death rates compared with a placebo group. Pfizer wants to have results before the end of the year for that study, which could support a filing for emergency authorization if successful, a company spokesperson told Insider.

Pills to prevent sickness

A headshot of Enanta Pharmaceuticals CEO Jay Luly
Enanta Pharmaceuticals CEO Jay Luly.

Other drug developers are betting there will be room for improvement beyond this first wave of oral antivirals. Those companies include Enanta Pharmaceuticals, a small Massachusetts biotech looking to start initial human testing early next year for its own coronavirus pill.

"Just because you have something moving forward that you're going to have data by the end of the year, it doesn't mean it's going to be good data," Enanta CEO Jay Luly told Insider.

There are also clinical trials looking at giving the antivirals even earlier - before people are sick.

Merck and Pfizer are already recruiting volunteers for prophylaxis trials, which are designed to see if their pills will prevent infection and symptomatic disease in the first place. Both studies are recruiting people who live with someone who has symptomatic COVID-19. Roche also plans to start a similar prevention study before year-end.

"We know antivirals, even in these acute respiratory infections, work really well as prophylaxis," Merck's Hazuda said.

HIV-treatment research is the most compelling example of this, Hazuda said; pre-exposure prophylaxis treatment for HIV is up to 99% effective at preventing infection after exposure to the virus. That same concept has held true for flu and respiratory syncytial virus treatments, she added.

Hazuda also said she saw a role for Merck's antiviral beyond COVID-19 in tackling future pandemic threats. Molnupiravir, Hazuda said, has shown activity against a variety of viruses in lab studies, including Ebola. While it has a long way to go from being an effective treatment, it could help prepare against future pathogens, she said.

"We're very excited that it could be something we have readily on hand that could play an important role in future zoonotic transmissions of other coronaviruses, as well as future outbreaks of new strains of influenza virus," she said.

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The FDA’s expert panel backs COVID-19 booster shots for adults 65 and older and those at highest risk of severe disease

covid vaccine
The FDA still has to make the final call on who can get boosters when. Their decision could come as early as Friday night.
  • An expert panel recommended that the FDA authorize booster shots for older and vulnerable adults.
  • The doctors and health experts who advise the FDA say data suggests younger people are still well protected.
  • The panel voted down a proposal to make boosters available to everyone 16 and older.
  • See more stories on Insider's business page.

An expert panel advising the US Food and Drug Administration said on Friday that a booster shot of Pfizer's coronavirus vaccine should be made available to older adults and others at high risk from the pandemic, under an emergency use authorization.

While the committee was persuaded by the evidence that a third dose of the Pfizer-BioNTech vaccine would help those at highest risk, the group was not convinced to include younger people now.

The group initially voted 16-2 to reject the idea of a third dose for everyone 16 years and older. That was a defeat for Pfizer, which wanted to make the booster shots available to all adults.

"We continue to believe in the benefits of a booster dose for a broader population," Kathrin Jansen, head of vaccine research and development at Pfizer, said in a statement after the meeting. "Boosters will be a critical tool in the ongoing effort to control the spread of this virus."

A recommendation for limited booster shots

Committee members proposed the more limited recommendation that FDA issue an emergency use authorization for a third dose of Pfizer for those over 65, and for people at high risk of severe cases of COVID-19. The vote for that proposal was unanimous (18-0).

Experts have said there is a clearer rationale and more data to support booster doses for those populations, at six months after their first two Pfizer shots. Several experts previously told Insider that boosters should be rolled out now for older adults.

The panel also voted to suggest that the FDA make the booster available to people who are at higher risk of being exposed to the virus at work, such as healthcare workers and teachers.

The FDA isn't required to follow the recommendations of its advisory committees, meaning it could still decide to approve booster shots for everyone 16 and older.

"The incremental benefit to the younger population really has not been demonstrated at all," Dr. Michael Kurilla, an infectious disease expert from the National Institutes of Health who sits on the panel, said during the meeting.

"I think we need to target the boosters right now specifically to the people who are likely to be at high risk, and it's an older population."

The FDA's interim leader, Dr. Janet Woodcock, signed on to an August 18 joint statement from a range of government health leaders that stated booster shots would be needed for the general public and would start rolling out on September 20, pending FDA and CDC reviews.

FDA CDER Director Dr. Janet Woodcock
Dr. Janet Woodcock.

The Pfizer votes could also shape other booster-shot applications. Moderna has applied for FDA approval for a third dose, and Johnson & Johnson has also described preliminary data on giving an extra dose of its single-shot vaccine.

Experts have criticized Biden's booster-shot plan for being prematurely announced and potentially applying political pressure to the FDA and CDC review processes.

Several experts on the panel expressed concern that there wasn't enough safety data for the booster shot to recommend approving it for younger adults. In particular, they highlighted the risk of myocarditis, or heart inflammation, that has been seen at higher-than-usual levels in teenagers and 20-somethings who have been vaccinated.

"I have major concerns with regard to the extrapolation of data from much older populations to 16 and 17 year olds," said Dr. Archana Chatterjee, a pediatric infectious disease expert and dean of Chicago Medical School who sits on the panel. "We have no data on the safety in this population at all."

Data presented to FDA panel leans on Israel's experience

Some of the strongest data in favor of boosters comes from Israel, which began rolling out a booster to its older population at the end of July and has since offered it to people as young as 12.

Chatterjee called the data from Israel "compelling" for people over age 60.

Israeli health officials presented data to the panel showing a dramatic decrease in infections and severe disease among older people who received boosters. Their study compared these individuals to people who had received two doses and no booster.

Israel would have likely exceeded its hospital capacity if the nation waited longer to give boosters, Dr. Sharon Alroy-Preis, head of public health services for Israel's health department, told the committee.

Pfizer presented data showing protection from its vaccine against infection waned over time, particularly at six to eight months out. But a study from Kaiser Permanente showed protection against hospitalization was durable, remaining just as high five months out from vaccination.

The Israel data suggests that the booster can restore the initial highs of vaccine protection against infection. But there's no long-term data to know if that infection protection will last longer this time around. And the FDA's review made it clear the agency believes the vaccines are still working quite well at preventing hospitalization and death.

Still, getting unvaccinated people their first shots remains the top priority in the US.

"At this moment, it is clear that the unvaccinated are driving transmission in the United States," Amanda Cohn from the CDC said during the meeting.

Cohn said that masks and social distancing "will have to be part of the solution" too, because "vaccination will never be perfect" at preventing every case.

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A massive study from Israel suggests older adults were far less likely to develop severe COVID-19 after a booster shot, but the finding carries major limitations

israel vaccine
An Israeli receives a coronavirus vaccine from medical staff at a COVID-19 vaccination center in Tel Aviv, Israel, Wednesday, Jan. 6, 2021.
  • A third dose of Pfizer's coronavirus vaccine dramatically reduces the risk of infection and severe illness for older adults, a new study found.
  • A team of researchers in Israel published the findings Wednesday in The New England Journal of Medicine.
  • Still, an expert urged caution on interpreting the findings, saying the study has major limitations.
  • See more stories on Insider's business page.

Older adults in Israel who received a booster shot of Pfizer's coronavirus vaccine were far less likely to get infected or develop severe illness, a massive study published on Wednesday found.

Including more than 1.1 million people who are 60 and older, the study looked at thousands of infections and hundreds of cases of severe illness, providing some of the most compelling evidence yet on the value of booster shots.

Israel started offering booster doses to its older population on July 30, and a group of researchers analyzed national healthcare records through the month of August.

Israeli study shows boosters cut the risk of infection and severe cases of COVID-19

The main finding was the older population, when boosted, was 11 times less likely to get infected and 19.5 times less likely to get severely ill compared to similar people who had received two doses but not a booster shot.

The study is likely to be influential, because its publication comes just two days before the Food and Drug Administration convenes an independent expert panel to discuss Pfizer's application to give booster shots in the US. Israeli health officials are scheduled to present findings from their booster campaign at that Friday meeting, and US health officials have pointed to Israel's experience to bolster their argument for booster shots.

The Biden administration has already said it plans to start offering booster shots to the general public on September 20, depending on OK's from the FDA and the Centers for Disease Control and Prevention.

In the Israeli study, the group that didn't get boosters recorded 4,439 infections and 294 severe illnesses. The booster group had 934 infections and 29 severe cases. The risk reduction rates accounted for the fact that the two groups were not even in size, as far more people joined the booster group over time.

The data should be viewed with caution

The result that booster shots reduced the risk of severe illness by nearly 20-fold is surprising, and should be viewed with some skepticism, said Ellie Murray, an epidemiologist at Boston University.

The study has major limitations, she said. Most notably, the researchers observed the real world, rather than testing a booster under more controlled conditions. This means there can be a lot of factors that could skew the results.

As one example, the group of people who are first in line to get boosted may be more cautious with other virus-prevention methods, like masking or social distancing. They could be less likely to get infected for those reasons, instead.

Additionally, the study has a very limited follow-up time, and doesn't show how long protection from boosters may last. That's an essential question in figuring our whether a booster campaign is worth launching.

The study's limited duration may skew its findings. Researchers started counting cases for the booster group only when they are 12 days removed from the third dose.

It can take up to a month on average for a person to go from exposed to infected to seriously ill, Murray said. Therefore, the study may not include enough follow-up time to show the true effect of the boosters.

There aren't any high-quality studies on booster shots

"It's not clear to me that there's anywhere near enough follow-up time, even for the earliest boosters," Murray said.

"All of these problems together make it really hard to know how much we can trust that number that comes out of the study," Murray added.

The broader challenge is that there's an absence of high-quality data that provides better answers to these questions. The leading vaccine developers are not running randomized, controlled trials testing booster doses against a placebo and seeing which group fares better in the long run. Instead, drugmakers have run small studies, boosting a few hundred people and finding an elevated immune response, which may suggest but not prove better protection, particularly against severe illness.

The Israeli researchers attempted to account for a number of potential confounding factors, including demographic differences between the boosted and non-boosted populations in Israel. They analyzed the data with several techniques that produced slightly different numbers but the same overall result: a massive reduction in infection risk, lying somewhere between 10-times and 13-times lower for the boosted population, depending on the analysis performed.

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The Biden administration will start rolling out COVID-19 vaccine boosters in September, offering most people another shot 8 months after vaccination

joe biden coronavirus vaccine passports
  • Most people in the US will be offered a COVID-19 booster shot about eight months after vaccination.
  • The plan aims to better protect Americans from the coronavirus amid a surge driven by the Delta variant.
  • Some experts have said there isn't yet data showing that we need booster shots.
  • See more stories on Insider's business page.

The Biden administration rolled out its plan Wednesday for giving booster shots of the COVID-19 vaccine, saying most people in the US will be offered another dose about eight months after their initial vaccination to bolster their protection.

The decision comes as the Delta variant fuels a coronavirus surge in the US, with the daily average of new cases over the past week hovering around 140,000 - the highest levels since February. Hospitalizations and deaths have also increased, especially in the South, though the vast majority are occurring among people who aren't vaccinated.

The booster-shot campaign will begin September 20 for people who received Moderna or Pfizer-BioNTech vaccines, government officials said. People who got the single-dose Johnson & Johnson vaccine will probably need boosters as well, though officials are still evaluating data on that vaccine.

The US Food and Drug Administration needs to authorize booster shots from each vaccine-maker before they can be rolled out. People will likely be eligible for boosters eight months after they received their second dose of the two-dose immunizations.

Booster shots will be free to individuals, and available at about 80,000 locations including pharmacies, Jeff Zients, the White House's COVID-19 response coordinator, said during a press conference. He said the US has enough vaccines to give everyone an extra dose.

US health officials leading agencies including the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health released a statement Wednesday saying the data is "very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination."

"Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout," the public-health leaders said in the statement. "For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.

Health officials said Wednesday the latest study results show waning effectiveness from the vaccines, particularly in preventing symptomatic illness. One new CDC study, for instance, found the Pfizer and Moderna vaccines lowered the risk of a coronavirus infection by 75% in nursing homes from March to May, before the Delta variant became dominant in the US. But from June to August, after the variant had spread widely, those vaccines only lowered the risk of infection by 53%.

While Moderna and Pfizer are both working on newer versions of their vaccines tailored to protect against Delta and other variant, these booster shots are expected to be similar to the shots that people are already receiving.

Both drugmakers have recently presented data showing that booster shots can increase the immune system's ability to fend off the Delta variant.

The decision comes amid an ongoing debate over whether or not booster shots are needed. Some vaccine experts have said there isn't enough data to justify giving boosters now, and the vaccines are still highly effective at preventing hospitalizations and deaths. They also contend that the goal should be to get initial vaccine doses to more people, both in the US and around the world.

On the other side, executives at vaccine-makers Pfizer and Moderna have argued it's best to be proactive. As Moderna CEO Stéphane Bancel has repeatedly put it, he'd rather have the US offer boosters two months too early than two months too late.

Health workers and vulnerable people to get boosters first

pfizer vaccine covid 19 nursing homes
Vera Leip, 88, receives a Pfizer-BioNtech COVID-19 vaccine at the John Knox Village Continuing Care Retirement Community on December 16, 2020 in Pompano Beach, Florida.

By tethering booster shots to the time of initial vaccination, the booster campaign will follow a similar sequence to the initial rollout of shots: healthcare workers, as well as the elderly and other vulnerable people first, followed by younger and healthier populations.

It's unclear how many vaccinated people will decide to get a booster; Michael Yee, a biotech analyst at Jefferies, estimated in an August 10 research note that about 30% of immunized people would get a booster.

The US has already started offering booster shots to a small group of people with weakened immune systems. Those shots are only available to people who were initially vaccinated with shots from Pfizer-BioNTech or Moderna.

About nine in 10 fully vaccinated Americans received two doses of either the Moderna or Pfizer-BioNTech vaccines, which both use a similar technology.

Nearly 14 million people in the US received the single-dose J&J vaccine. The health officials said they expect data that will help them decide on a booster-shot plan for people who received that vaccine in the next few weeks.

To date, the US has administered more than 357 million doses of COVID-19 vaccines. About 169 million people in the US are fully vaccinated, or just over half of the nation's population. Children younger than 12 still aren't eligible to get coronavirus vaccines.

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Delta’s surging and antibodies are waning: What to know about when we’ll need COVID-19 booster shots

A healthcare professional wearing a mask fills a syringe of the Moderna COVID-19 vaccine from a glass vial.
Moderna has soared over the past year on the back of its coronavirus vaccine.
  • Should the US start offering people an extra COVID-19 vaccines dose?
  • Supporters cite signs of waning protection and data suggesting a booster shot would help.
  • Others say boosting now is unnecessary, because the shots still prevent hospitalizations and death.
  • See more stories on Insider's business page.

The debate over whether the US should roll out extra doses of coronavirus vaccines is reaching a fever pitch.

Pfizer and Moderna, the pharmaceutical companies selling two of the widely used US vaccines, have forcefully argued that booster doses will be necessary before the winter. Some vaccine experts have been just as forceful in saying they aren't needed yet.

"No vaccine, at least not within this category, is going to have an indefinite amount of protection," Dr. Anthony Fauci, the nation's top infectious-disease expert, said in an interview with NBC News on Thursday.

"What we're doing literally on a weekly and monthly basis is following cohorts of patients to determine if, when, and who should get it," he said later. "But right now, at this moment, other than the immunocompromised, we're not going to be giving boosters to people."

Whether it's the opinions of independent experts, recommendations from drug companies, or the latest research fueling the debate, there are compelling arguments for and against rolling out booster doses to the broad US population.

It isn't obvious there's a clear answer at this point, which makes for a good argument as well as a tricky public-health situation. The rise of the Delta variant, which partially lowers protection from vaccines, is adding to the urgency of the situation.

Read more: We got an exclusive look inside Moderna's labs, where the biotech upstart is planning what comes after its blockbuster coronavirus vaccine

The narrow exception here, where both sides agree, is that some Americans do need to be boosted now. Regulators have OK'd third shots for certain people who have severely weakened immune systems, in the hopes of increasing their protection against the coronavirus.

The case in favor: Better safe than sorry

Two patients with COVID-19 in hospital beds while a doctor wearing full personal protective equipment leans over to check on one.
A doctor checks the vital signs of a patient at the intensive care unit of Providence Cedars-Sinai Tarzana Medical Center in Tarzana, California on January 3.

We know that protection from the coronavirus vaccines peaks a few weeks after people get the second dose of a Pfizer or Moderna shot, then gradually declines.

The critical unknown is how fast it wanes and when we should care enough to act.

The vaccine developers Pfizer and Moderna have recently said that third doses should be rolled out between six and 12 months after the first two doses.

In part, that's because data from Pfizer's massive study testing its vaccine shows protection against symptomatic cases of COVID-19 fell from 96% to 84% over six months. Moderna has presented data showing the antibodies produced by its shot are not nearly as abundant and powerful when exposed to circulating variants after about six months.

The companies have also presented lab data showing a third dose significantly increases the level of virus-killing antibodies in people. Those boosted antibodies are also active in fighting the Delta variant. That matters because there's more research suggesting that neutralizing antibodies correlate strongly to protection against COVID-19.

The vaccine makers do have a clear financial incentive to pitch booster doses. Moderna, in particular, has seen its valuation explode from $7 billion to more than $160 billion through the pandemic, thanks to its COVID-19 vaccine work that is now bringing in billions in revenue.

Reports of waning protection are spurring booster shots

Still, information from the UK, Israel, and Mayo Clinic researchers does show that protection from the vaccines seems to be decreasing, adding to the case for boosters.

Perhaps most shockingly, Israeli health officials said they have seen protection against severe illness tumble from 97% in April to 81% in July among people who are 60 and over. While that data has yet to be published or posted on a preprint server, it is informing that country's public-health strategy.

Israel is in the middle of an aggressive booster campaign, opening eligibility for extra doses to everyone 50 years and older and healthcare workers, among others. France and Germany are also forming booster plans that will start to give third shots in September.

So much of the pandemic has boiled down to problems of reacting rather than anticipating and preventing. Signs are emerging that protection is waning, and a booster shot holds the promise of patching up immunity. Why not try to maximize protection with the tools available?

The case against: Boosters are unnecessary, selfish

Dr. Paul A. Offit speaks at a press conference while Pennsylvania Sen. Bob Casey Jr. looks on
Dr. Paul A. Offit speaks during a news conference in Philadelphia.

Dr. Paul Offit, a longtime vaccine developer who sits on the FDA's vaccine advisory committee, says it's not yet time for booster shots.

That's because the objective of these vaccines is not to prevent every infection. Instead, the aim is to prevent people from being hospitalized with COVID-19 or dying. They're still doing that extraordinarily well, Offit said.

When you take that perspective, some of the same studies driving concern look reassuring.

Take the Mayo Clinic study (and it's worth emphasizing that this is preliminary research).

While a sharp drop in effectiveness for Pfizer's vaccine in July has drawn attention, the same study found that its effectiveness at preventing the worst COVID-19 outcomes held up.

The shots are still working

Pfizer's shot was 75% effective at preventing hospitalizations, roughly in line with previous month. Moderna's vaccine was 81% effective by that measure.

a headshot of Dr. Maria Elena Bottazzi
Dr. Maria Elena Bottazzi.

Overall, the Mayo results show the vaccines are working, said Maria Elena Bottazzi, a vaccine developer at Baylor College of Medicine.

"It's still not really, really clear by the data if it's advantageous to get a third boost now if you're a normal, healthy person with a normal immune response," Bottazzi said. "We're still seeing great protection by the vaccines against the Delta variant."

Another good example is the outbreak in Provincetown, Massachusetts, which drew headlines because most of the people infected were also fully vaccinated. But a CDC analysis of a subset of those cases found that out of 346 fully vaccinated people who got infected, only four, or roughly 1%, were hospitalized and no one died.

"That's a vaccine that is still working," Offit said.

Much of the world still needs doses

If outbreaks increasingly send fully vaccinated people to the hospital, that's when you'll know we need boosters. That's not happening as of now, Offit said.

Finally, giving boosters overlooks the far more pressing issue of getting more people vaccinated, Offit and Bottazzi said.

The World Health Organization is pleading with rich nations to hold off on boosters until at least the end of September so other countries can get more of their populations immunized.

"I would rather see more people get protected against severe disease and deaths and hospitalizations, even if we all have breakthrough infections because that's what's going to stop this virus from continuing to mutate," Bottazzi said.

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The FDA will allow COVID-19 booster shots for some people with weakened immune systems

Registered Nurse Robert Orallo, wearing a face mask and blue gloves, injects a syringe containing a COVID-19 vaccine into a patient's arm
A nurse administers the Pfizer-BioNTech coronavirus vaccine in Alaska.
  • The FDA has expanded the emergency authorizations for leading COVID-19 vaccines.
  • That paves the way for patients with weakened immune systems to start receiving booster shots.
  • It remains unclear when, or if, extra doses would be rolled out to everyone in the US.
  • See more stories on Insider's business page.

The US Food and Drug Administration on Thursday took a key step toward allowing some of the most vulnerable Americans to receive booster shots - or a third dose - of coronavirus vaccines.

The FDA tweaked the language in its emergency authorizations for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow doctors to consider giving additional doses for people with weakened immune systems. Previously the Pfizer-BioNTech and Moderna shots were intended to be given as two doses several weeks apart, while J&J's shot was given as a single dose.

In recent weeks, US health officials and doctors have highlighted the need to start offering booster shots to certain groups of people with weakened immune systems, such as people who have received organ transplants. Giving an additional vaccine dose could help boost those people's protection against COVID-19.

Other countries, including Germany, France, and the UK, have already firmed up plans to soon start rolling out booster shots to their most vulnerable populations. Israel started offering extra shots to people with impaired immune systems in July.

CDC expected to urge immunocompromised to talk to their doctors about a booster dose

A hand holding a CDC card that reads "COVID-19 Vaccination Record Card"
A COVID-19 vaccination-record card.

Offering shots to some people with weakened immune systems is likely the first step in a broader booster-shot campaign.

About 2.7% of adults in the US, or 7 million people, have severely weakened immune systems, according to the Centers for Disease Control and Prevention. It's not clear whether the CDC will recommend that all immunocompromised people receive booster shots.

Diseases like HIV can weaken the immune system, as can certain cancer treatments and some drugs given to people who have received organ transplants or to treat conditions like arthritis.

Several research studies have shown that immunocompromised people mount far less of a response to the COVID-19 vaccines than the population at large. Some small studies suggest an extra dose boosted antibodies in about one-third to half of immunocompromised patients.

Dr. Camille Kotton, an infectious-disease and transplant specialist at the Massachusetts General Hospital, said at a CDC meeting in July that many patients "have taken matters into their own hands and are proceeding with additional doses as they see fit."

Kotton sits on an independent advisory committee to the CDC, which issues recommendations on how to use vaccines.

That committee has discussed the topic of booster shots for immunocompromised people, but its members have said they needed to wait for the FDA to update the authorizations for the vaccines before recommending any booster shots.

Kotton said the regulatory situation limited doctors from recommending booster shots.

That CDC advisory group is set to meet on Friday to further discuss booster doses. While a formal vote is not on the agenda, the advisory group is expected to urge immunocompromised people to talk with their doctors or pharmacists about getting an additional shot, The Washington Post reported.

FDA's actions do not mean booster shots for everyone

While the vaccine makers Pfizer and Moderna have argued that everyone should get a third shot of their vaccines after six to 12 months, US regulators and public-health officials are, so far, unconvinced.

The drug companies have cited data showing modest declines in real-world protection against the virus, particularly with the rise of the Delta variant. They've coupled that with lab studies showing large drops in virus-fighting antibody levels, which they say support the case that protection wanes after at least six months.

A headshot of Moderna President Dr. Stephen Hoge
Moderna President Stephen Hoge.
"We believe a booster dose is likely to be necessary this fall," Moderna President Stephen Hoge said on August 5.

Vaccine experts like Dr. Paul Offit, who sits on the FDA's vaccine-advisory committee, have said that booster doses wouldn't be needed unless fully vaccinated people started to get seriously ill from COVID-19.

The FDA is working on a more comprehensive plan for boosters, and The Wall Street Journal reported that work won't be completed until early September.

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Sanofi and GlaxoSmithKline say their COVID-19 vaccine triggers a strong immune response, bolstering the late-comer program’s potential as a booster shot

FILE PHOTO: Paul Hudson, chief executive officer of Sanofi, poses during the annual results news conference in Paris, France, February 6, 2020. REUTERS/Benoit Tessier
Sanofi CEO Paul Hudson
  • Sanofi and GlaxoSmithKline said that their experimental COVID-19 vaccine succeeded in a mid-stage trial.
  • The pharma giants plan to launch a pivotal-stage study with 35,000 volunteers in the coming weeks.
  • The shot suffered from disappointing data and delays in 2020. The companies now hope for approval by year's end.
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One of the world's most closely watched coronavirus vaccine programs reported positive data on Monday from a mid-stage clinical trial, paving the way for the start of a massive human trial that could allow the shot to be authorized before the end of this year.

Sanofi and GlaxoSmithKline, two of the largest vaccine-makers in the world, said in a press release that their experimental coronavirus vaccine led to strong immune responses across all ages in a study that enrolled 722 volunteers. It's a much-needed piece of positive news for the two industry leaders, which saw their vaccine effort delayed by disappointing data announced in December, and have fallen far behind rivals like Moderna, Pfizer-BioNTech, and Johnson & Johnson.

Read more: GlaxoSmithKline stumbled with COVID-19 shots. Now it's facing an exodus of US talent and an uncertain future as the world's vaccine leader.

The companies did not release specific data on the antibody response, nor did they publish results in a peer-reviewed medical journal or post a paper on a preprint server.

Emma Walmsley
GSK CEO Emma Walmsley

Instead, the companies issued a press release describing the neutralizing antibody responses as "comparable to those generated by natural infection."

Neutralizing antibodies are the virus-fighting proteins that play a critical role in our immune response. GSK and Sanofi added that younger volunteers had generally stronger immune responses to the vaccine.

The two pharma giants expect to launch a final-stage clinical study, called a Phase 3 trial, in the coming weeks that will enroll more than 35,000 people. They also plan to simultaneously run smaller studies that test their vaccine, including versions tailored to neutralize specific coronavirus variants, as booster shots in people who've already been immunized.

If everything goes to plan, Sanofi and GSK expect their vaccine to be approved in October, November, or December of 2021, the companies said.

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The US just authorized Pfizer-BioNTech’s coronavirus vaccine for teenagers, making it the first COVID-19 shot OK’d for 12- to 15-year-olds

16-year-old participates in coronavirus vaccine trial for Pfizer at Cincinnati Children's Hospital, pediatric vaccine studies COVID-19
A 16-year-old in Pfizer's clinical trial to test its coronavirus vaccine candidate.
  • US regulators have OK'd Pfizer-BioNTech's coronavirus vaccine for use in younger teenagers.
  • The two-dose shot is the first vaccine to be authorized for use in the 12- to 15-year-old age group.
  • US health officials have said they will soon be ready to start giving the shot to kids.
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Teenagers in the US are now eligible for a leading coronavirus vaccine, as the Food and Drug Administration on Monday expanded the authorization for Pfizer-BioNTech's COVID-19 shot to include 12- to 15-year-olds.

The two-dose vaccine was approved in December for anyone 16 years old and up. US health officials said they were prepared to soon start giving the shot to younger teenagers.

Canada is the only other country to have OK'd a COVID-19 vaccine for younger teenagers. On May 5, it authorized Pfizer's vaccine for use among people 12 and older.

Expanding eligibility to include the younger age group could give the immunization campaign a boost. The US has seen the daily rate of people getting their first dose plummet since early April, from a peak of 1.9 million people a day to about 830,000 a day, according to data from the Centers for Disease Control and Prevention.

A major driver for that decline has been that a majority of adults in the US have already received at least one dose. About 58% of US adults have received at least the first dose of a vaccine, according to CDC data.

"Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic," Dr. Janet Woodcock, the acting commissioner of the FDA, said in a statement. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations."

Pfizer tested the vaccine in a clinical study that enrolled 2,260 children ages 12 to 15. Half of the volunteers received Pfizer's shot, while the other half got a placebo injection. Overall, the trial recorded 18 COVID-19 cases, all in the placebo group. Side effects of the shot were in line with those observed in people 16 to 25 years old, Pfizer said.

Pfizer and other vaccine developers are also testing COVID-19 shots in younger populations down to 6-month-olds

The New York drugmaking giant is still testing the shot in younger ages, hoping to further expand its eligibility later this year.

In September, Pfizer anticipates study results showing whether the shot works in children ages 2 to 11.

The final step down for kids - from 6-month-old babies to 2-year-olds - should produce data in November, according to Pfizer's projections.

Other leading vaccine developers are also testing their shots in younger populations.

On May 6, Moderna said its vaccine was highly effective in an initial review of a clinical trial enrolling more than 3,000 teenagers. The Massachusetts biotech said it was "in discussions with regulators about a potential amendment to its regulatory filings" after those early results. Moderna is also enrolling volunteers for a study testing the vaccine in kids 11 years old all the way down to 6 months old.

Johnson & Johnson also started testing in April its single-dose vaccine in adolescents 12 to 17 years of age.

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We just got our first evidence that Moderna’s coronavirus booster shot works to fight variants

Moderna vaccine
A lab tech processes blood samples from participants in Moderna's coronavirus vaccine clinical trials in Miami on September 2.
  • Moderna said Wednesday that a third dose greatly boosted antibody levels in volunteers in a study.
  • An updated vaccine tailored against the B.1.351 coronavirus variant worked best, the company said.
  • These are the first clinical results from any vaccine developer testing an updated COVID-19 shot.
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Moderna is voicing confidence in a new version of its coronavirus vaccine tailored to fight variants of the virus. The biotech on Wednesday released data from a clinical trial testing its booster doses.

These are the first clinical results from any vaccine developer testing an updated COVID-19 shot. Moderna started research earlier this year to see whether it could develop a booster shot that would better protect against the B.1.351 variant, first found in South Africa.

Earlier research, done in petri dishes, suggested the B.1.351 variant was able to partially reduce the effectiveness of leading vaccines, including those from Pfizer and Moderna. The current shots likely still work against variants, but experts have said it's less clear how long that protection will last.

The latest findings could support the rollout of variant-specific booster doses, potentially as soon as the end of 2021 or 2022 in some countries, Moderna executives recently said.

While no one knows exactly when people would need booster shots, experts generally think the presence of variants that can partially degrade the efficacy of vaccines will speed up the need to give additional shots, particularly to the most vulnerable populations.

Researchers tried 3 kinds of boosters in the clinical trial

In the new clinical trial, Moderna tested a third dose in people who had gotten the two-dose vaccine six to eight months ago.

The study volunteers received one of three options: another dose of Moderna's original vaccine, a new version tailored to the B.1.351 variant, or a multivalent version with a 50-50 mix of the original and B.1.351 vaccines.

In a press release on Wednesday, Moderna described initial results from the original vaccine and the B.1.351 shot. The company plans to later report on the multivalent version and to test an even lower dose strength. The research has not been published in a peer-reviewed medical journal, and Moderna said it had submitted the paper to a preprint server.

Before the volunteers got the third dose, Moderna tested blood samples to see how durable the vaccine response had been through six to eight months. While 37 of the 40 people had detectable levels of antibodies, the virus-fighting proteins that are the backbone of our immune response, only about half of the participants had detectable levels of antibodies against the B.1.351 variant and P.1, the variant first identified in Brazil, Moderna said.

One booster shot was most effective and led to fewer reactions

The study found that the people who were given the B.1.351-specific booster had the most effective immune response. Antibody levels were about 62% higher in that group than in the group given another dose of Moderna's original shot, Moderna said.

"We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants," Moderna CEO Stéphane Bancel said in a statement. "The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory."

Moderna said the booster shots were well tolerated overall, with people having reactions similar to those after the second dose.

The B.1.351 booster shot appeared to produce slightly less severe reactions, Moderna said. About 11% of the people who got the variant-specific booster reported a grade-three adverse event, which is severe enough to affect daily living, compared with 15% who got the third dose of the original shot.

The most common side effects were fatigue, headache, muscle pain, and joint pain.

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The US will help India produce more coronavirus vaccines, releasing raw materials and expanding factories in broad push to blunt its COVID-19 crisis

India
People are administered COVID-19 vaccine in Mumbai, India, Tuesday, April 13, 2021.
  • The US will provide supplies for testing, drugs, and vaccines to fight India's COVID-19 crisis.
  • A National Security Council spokesperson said the US is "working around the clock" to help India.
  • Resources include raw materials and funding needed needed to ramp up vaccine manufacturing.
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The US is providing a broad package of relief to India, government leaders said Sunday, as the world's second-most populous country fights a historic wave of COVID-19.

The US will immediately make available raw materials needed to produce Covishield, the Indian brandname for the AstraZeneca-University of Oxford vaccine, as well as personal protective equipment, testing kits, drugs, and ventilators, Emily Horne, a spokesperson for the US National Security Council, said in a statement Sunday.

The US will also fund an expansion of one of India's leading vaccine manufacturers, BioE. Money from the US Development Finance Corporation will allow BioE to produce 1 billion doses of coronavirus vaccine by the end of 2022, Horne said.

Horne's statement followed a Sunday call between US National Security Advisor Jake Sullivan and Ajit Doval, the top national security advisors for India. The readout did not specify how much raw materials, diagnostics, therapeutics, and other medical equipment will be provided by the US' action.

India recorded 349,691 new cases on Sunday, smashing a global record for a fourth consecutive day. Hospitals are being overrun and medical supplies are in short supply. Vaccinations have also been few and far between, with less than 2% of the population fully immunized.

Over the last few days, a growing chorus of doctors and public-health experts have urged the US government to do more, including donating vaccine doses and providing raw materials.

Horne's statement did not reference a donation of any existing vaccine doses that the US has. Some experts have called for the US to donate its supply of AstraZeneca's shot, which has not won authorization in the US.

The US government signed a deal with AstraZeneca last summer to eventually deliver 300 million doses of the shot. The US already has at least 30 million of those doses on hand, a supply which experts say would be best used by donating to other nations that need it.

Dr. Ashish Jha, dean of Brown University School of Public Health, called the US' assistance "excellent steps," while noting it does not mention using the American supply of AstraZeneca's shot.

The US and India will "stay in close touch in coming days," Horne said, with the US "working around the clock to deploy available resources and supplies."

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