US Okays Moderna Vax, Novavax Seeks Approval, Joe Rogen…Truth or Fiction, Drug Pricing

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FDA fully approves Moderna vaccine

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The Food and Drug Administration (FDA) on Monday granted full approval to Moderna’s COVID-19 vaccine, giving an additional vote of confidence in its safety and effectiveness.

The full approval for people ages 18 and older was based on follow-up data showing “high efficacy and favorable safety approximately six months after the second dose.”

The vaccine had already been available since December 2020 under an emergency use authorization, but full approval provides an extra emphasis.

Acting FDA Commissioner Janet Woodcock said she hoped the move gives some people additional confidence in the vaccine.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” she said in a statement. “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”

Latest numbers: About 74 percent of adults are now fully vaccinated, according to Centers for Disease Control and Prevention data. The numbers are much lower for boosters, which are crucial for achieving higher protection against the omicron variant, with 44 percent of fully vaccinated adults having received a booster, according to the public health agency.

Novavax asks FDA to authorize its vaccine

 

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In the other big COVID-19 vaccine news, Maryland-based Novavax finally applied for emergency use authorization for its vaccine in adults.

The request was based in part on results from two large clinical trials of approximately 30,000 participants in the U.S. and Mexico. The company said two doses of the vaccine given three weeks apart demonstrated an overall efficacy of approximately 90 percent, though the trials took place before the omicron variant became dominant.

Novavax was one of the six companies the U.S. invested in as part of Operation Warp Speed. The company originally wanted to ask the FDA for authorization by May 2021, but had to delay the request multiple times due to numerous development and manufacturing setbacks.

The protein-based vaccine could provide an alternative to the mRNA shots available from Pfizer and Moderna, as there is a small risk the mRNA vaccines cause heart inflammation in certain adults.

The authorization process from FDA could take several months, though the vaccine is available under emergency use from the European Commission, and the World Health Organization.

The Novavax vaccine is given in two doses spaced 21 days apart; the company recently announced plans to test a booster shot.

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Joe Rogan’s Covid claims: what does the science actually say?

Podcaster has made numerous disputed claims about virus, vaccines and lockdowns

Joe Rogan performing in 2019.
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‘I get things wrong’: Joe Rogan responds after Spotify misinformation backlash – video

Spotify has said it will add “content advisories” to episodes of Joe Rogan’s podcast discussing Covid after the singers Neil Young and Joni Mitchell accused the streaming service of helping to spread Covid misinformation.

The musicians are critical of Rogan, who has recently sparked controversy over comments made by himself and some of his guests about the pandemic.

So, what does the science say about some of Rogan’s most controversial claims?

Healthy young people don’t need a Covid vaccine’

Rogan has claimed he isn’t anti-vaccine, but during a 23 April 2021 episode of his podcast he said: “If you’re like 21 years old, and you say to me, should I get vaccinated? I’ll go, no.”

Although it’s true that older people are at greater risk of severe disease and death, younger people can and do die from Covid-19. According to the latest UK Health Security Agency (UKHSA) figures, there have been 39 deaths in 20- to 29-year-olds with laboratory-confirmed Covid in England since January 2021.

Among those aged 30-39, there have been 185 deaths during the same period. That’s lower than the 18,931 deaths in people aged 80+, but not insignificant.

“Young people still get severe illness from Covid-19, and the benefits, directly to the young person, purely in terms of their risk of serious illness are much greater than any risks from vaccination,” said Dr Richard Tedder, a member of the UK Clinical Virology Network.

Separate research on 73,197 UK adults who were admitted to hospital during the pandemic’s first wave found that 27% of 19- to 29-year-olds suffered damage to their kidneys, lungs or other organs as a result of Covid-19, while 13% left hospital with a reduced ability to care for themselves.

‘The myocarditis risk is higher from vaccines than from Covid’

In his 12 January 2022 episode, Rogan claimed the risk of myocarditis (heart muscle inflammation) among vaccinated 12- to 17-year-olds was higher than the risk associated with catching Covid.

But his guest, the Australian broadcaster Josh Szeps, argued that, in fact, young males infected with the virus were up six times more likely to develop myocarditis as those who had received the vaccine. Szeps cited data from the US Advisory Committee on Immunization Practices, suggesting a rate of about 450 myocarditis cases in every million Covid-19 infections among boys aged 12-17, compared with 77 cases a million after vaccination.

Separate data from 38.6 million people aged 16+ who were vaccinated in England identified an extra two to six myocarditis cases in every million people in the 28 days after receiving a first dose of the AstraZeneca, Pfizer or Moderna vaccines, and an extra 10 cases a million after a second dose of the Moderna vaccine.

This compared with an additional 40 cases a million people in the 28 days after a positive Covid test.

“The risk of myocarditis is substantially higher following Covid infection than vaccination in the general population, but remains very infrequent following either,” said Nicholas Mills, a British Heart Foundation professor of cardiology at the University of Edinburgh, who was involved in the study.

“The majority of reports suggest that when it arises following vaccination it is mild and self-limiting.”

Ivermectin can drive this pathogen to extinction

During his 18 June 2021 podcast, Rogan’s guest, the evolutionary biologist Bret Weinstein, claimed that “ivermectin alone, if properly utilised, is capable of driving this pathogen to extinction”. On 2 September, Rogan announced that he had tested positive for Covid-19 and was also taking the anti-parasitic drug. Although he recovered, ivermectin is unlikely to explain why: according to a recent Cochrane Review, which analysed data from multiple studies, there is no evidence to support the use of ivermectin either for preventing or treating Covid.

“Because of a lack of good-quality evidence, we do not know whether ivermectin administered in hospital or in an outpatient setting leads to more or fewer deaths after one month when compared with a placebo or usual care,” its authors said.

‘mRNA vaccines are gene therapy

In his 20 August 2021, podcast, Rogan claimed the Pfizer and Moderna Covid-19 vaccines were not really vaccines, but gene therapy. “A vaccine is where they take a dead virus, and they turn it into a vaccine, and they inject it into your body so that your body fights off [the infection],” he said. “This is really gene therapy. It’s a different thing. It’s tricking your body into producing spike protein and making these antibodies for Covid.”

It’s true that mRNA vaccines persuade our own cells to manufacture the viral spike protein, which in turn prompts the production of antibodies. However, whereas gene therapy is designed to permanently alter an individual’s genes, mRNA vaccines issue instructions to protein-making machinery located in the cytoplasm, which degrade after about 72 hours.

Because immune cells are able to remember pieces of virus they’ve encountered, this temporary encounter still has a lasting effect, but it doesn’t alter our genome.

Other types of vaccines, such as the influenza or hepatitis B vaccine, also expose the immune system to viral proteins, albeit pre-assembled ones.

“I’m not gonna get vaccinated. I have antibodies, it doesn’t make any sense.”

On 24 December 2021, Rogan told the US comedian Tim Dillon that his Vancouver show had been cancelled because Canada required proof of vaccination to attend live events.

Referencing his earlier Covid infection, Rogan said “I’m not gonna get vaccinated. I have antibodies, it doesn’t make any sense.”

Although so-called natural immunity is likely to provide some protection against subsequent infection, vaccination would strengthen and extend the duration of that response.

Tedder said: “About one in five people who get Covid do not generate a useful immune response, and those who do gain a valuable ‘booster’ effect if they are subsequently vaccinated, deepening and enhancing their immune response so that it lasts for longer, and is better able to recognise new variants.”

Lockdowns ‘make things worse’

Rogan has also spoken out against lockdowns, arguing that they can perpetuate the spread of Covid-19. “It makes things worse, you know why – because people go inside. They are trapped inside and that’s where it spreads,” he said.

However, according to an analysis of the impact of lockdowns and social distancing in 11 European countries, published in Nature, such measures together have a “substantial effect” on transmission.

“It is true that, since the virus is airborne, transmission is more likely indoors, particularly if ventilation is poor; but the point of lockdowns is to reduce the number of contacts, and thus the likelihood of encountering somebody who is infectious,” Tedder said.

DRUG PRICING PRESSURE RISES

A group of 40 House Democrats is pressuring party leadership to act quickly on measures to lower prescription drug prices, highlighting the importance of the issue to the party, especially in an election year.

Lowering drug prices is a long-held policy goal for Democrats and a crucial aspect of their campaign messaging.

But the proposal is stalled in Congress along with a slew of other measures included in President Biden’s Build Back Better agenda, given concerns from Sen. Joe Manchin (D-W.Va.) about other parts of the package.

The group of Democrats, led by Rep. Susan Wild (Pa.), is pushing to jumpstart action.

“We write today urging you to take legislative action as swiftly as possible to lower drug prices,” the Democrats, many of whom represent competitive seats, wrote to Speaker Nancy Pelosi (D-Calif.) and Senate Majority Leader Charles Schumer (D-N.Y.). “For years, people have sent us to Washington on the promise that we end Big Pharma’s monopoly control over prices and provide patients with much needed relief. We must make good on that promise — and we have the ability to do so.”

Unclear path forward: But the proposal is facing a murky path forward, given the obstacles for the larger Build Back Better package of which it is a part. Manchin supports action to lower drug prices, but he has concerns about other parts of the package related to spending and the possibility of causing more inflation.

WARREN SECURES ETHICS PLEDGE FROM FDA PICK

President Biden’s nominee to lead the Food and Drug Administration (FDA) made significant ethics concessions to Sen. Elizabeth Warren (D-Mass.) in an effort to secure Democratic votes ahead of his confirmation.

In a letter to Warren, Robert Califf committed not to seek employment or compensation from any drug or medical device companies he interacts with as commissioner for four years following his tenure if confirmed.

Califf also committed to recuse himself from matters involving his former employers and clients for four years, two years longer than what is required in the Biden-Harris administration’s ethics pledge.

A spokesperson for Warren said the senator plans to support Califf if his nomination comes to a vote.

In 2016, Califf was easily confirmed by a vote of 89-4, but it’s not clear he has enough support among the necessary 50 senators this time around.

Hutchinson asks for path to endemic status

 

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Arkansas Gov. Asa Hutchinson (R) on Monday urged the Centers for Disease Control and Prevention (CDC) to provide clear guidance that will allow states to transition out of the COVID-19 pandemic and into endemic status.

“We need the CDC to help us to have the right standards to end this pandemic and move to more endemic status,” Hutchinson said during a meeting with President Biden, Vice President Harris and other governors as part of a meeting of the National Governors Association.

“And so that’s an important element that we as governors, in a bipartisan way, hope that the CDC can be helpful to define that more clearly,” added Hutchinson, who chairs the association. “We want to go from today to more normal.”

Context: Hutchinson’s call for a clear set of guidelines to help Americans ease back into normal life comes as recent polls have shown much of the public is fatigued and frustrated by the pandemic two years after the first cases were detected in the United States.

Still, President Biden can’t control a virus, and many areas of the country have already decided they are “done” with COVID, with no requirements for masks or vaccines anywhere.

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