Moderna stock remains under pressure despite winning authorization for its omicron-blocking booster shots in three global regions, including the U.S.
Regulators in the U.K. signed off onModerna's (MRNA) updated Covid booster. This shot aims to block infections caused by the BA.1 strain of omicron. Meanwhile, officials in the U.S. and Europe allowed boosters targeting the more current BA.4 and BA.5 subvariants.
Bullishly, Moderna reported unexpected sales growth in the second quarter. Sales of the Covid vaccine called Spikevax grew 8% to $4.53 billion. Analysts expected a sales decline of 9% to $3.83 billion. The results sent Moderna stock soaring for two days, then shares quickly hit the skids.
Moderna also won FDA authorization for its Covid vaccine in children as young as 6 months old. Officials in Canada and Australia followed suit this month. Further, advisors to the European Medicines Agency recommended Moderna's booster shot for adolescents age 12-17.
Still, 2022 is the last year of growth for Moderna stock that analysts predict until 2025. Moderna expects $21 billion in purchase agreements for its two-shot vaccine. But in 2023, analysts call for sales to fall by half to roughly $10.2 billion.
Importantly, Moderna is working to expand its non-Covid offerings. In July, Moderna dosed the first participant in a study of its Nipah virus vaccine. Nipah is a respiratory illness. The company also dosed the first person in a study of its seasonal flu vaccine.
So, all in all, is Moderna stock a buy today?
A Fundamental Look At Moderna Stock
By all measures, the second quarter represented a beat for Moderna. The company earned $5.24 per share, down 19%. But analysts called for a deeper decline to $4.58 per share. Overall sales grew 9% to $4.75 billion. That was better than calls for a 6% decline.
In addition to $4.53 billion from Spikevax, Moderna reported a smaller amount of collaboration money and grants.
But Moderna's second-quarter sales and earnings didn't line up with CAN SLIM advice. Investors are advised to seek companies with at least 20%-25% recent earnings growth.
Now, the question for Moderna stock remains how long it can sustain growth. Analysts currently expect sales to plummet in 2023 as Covid reaches the endemic stage. In the third quarter, analysts expect Moderna to earn $4.81 per share on $4.63 billion in sales. Earnings would decline 38% and sales would inch down 7%.
Moderna stock has a Composite Rating of 44 out of a best-possible 99. The Composite Rating is a measure of a stock's key fundamental and technical measures. So MRNA stock tops 44% of all stocks on that metric.
What Do Annual Metrics Say?
Moderna stock went public at 23 in late 2018. In 2020, shares rocketed more than 434%. The gain was less bullish in 2021 with shares rising 143%.
Fundamentals improved in 2021 following the late 2020 launch of Moderna's Covid vaccine. In 2021, Moderna earned $28.29 per share on $18.47 billion in sales. Earnings turned around from a year-earlier loss and sales skyrocketed.
Moderna is also targeting flu, respiratory syncytial virus and cytomegalovirus with vaccines. Further, it's testing treatments for rare diseases and cancer. The company also inked a deal with privately held Carisma Therapeutics in cancer treatment.
The market for Covid boosters also could remain intact for some time. The FDA now allows two rounds of messenger RNA boosters — depending on age and immune conditions. Moderna unveiled promising test results for two omicron boosters, both of which are now authorized in different regions.
Moderna expects $21 billion in sales of its Covid vaccine this year.
Now, MRNA stock analysts project $21.96 billion in 2022 sales and $26.65 in adjusted earnings per share. Sales would rise 19%, but earnings would decline 6%.
Pfizer Inc., New York, New York, was awarded a $4,852,867,500 modification (P00004) to contract W58P05-22-C-0001 for the oral therapeutic PAXLOVID. Work will be performed in New York, New York, with an estimated completion date of March 31, 2023. Fiscal 2022 American Rescue Plan Act funds; Coronavirus Aid, Relief, and Economic Security Act funds; Coronavirus Preparedness Response and Relief Supplemental Appropriations Act funds; and Coronavirus Response and Relief Supplemental Appropriations Act funds in the amount of $4,852,867,500 were obligated at the time of the award. U.S. Army Contracting Command, Aberdeen Proving Ground, Maryland, is the contracting activity.
The U.S. Centers for Disease Control and Prevention (CDC) passed misinformation to Facebook as the partners worked to combat misinformation, according to newly released emails, in the most recent example of CDC officials making false or misleading claims.
In a June 3 message, a Facebook official said the CDC had helped the company to “debunk claims about COVID vaccines and children,” and asked for assistance addressing claims about the vaccines for babies and toddlers, including the claim that the vaccines weren’t effective.
Several weeks later, after U.S. regulators authorized the Moderna and Pfizer vaccines for young children and the CDC recommended them, a CDC official responded by offering unsupported information.
“Claims that COVID-19 vaccines are ineffective for children ages 6 months to 4 years are false and belief in such claims could lead to back vaccine hesitancy,” the CDC official wrote. The names of all of the officials mentioned in this story were redacted in the emails, which were released as part of ongoing litigation against the U.S. government.
“COVID-19 vaccines available in the United States are effective at protecting people, including children ages 6 months to 4 years, from getting seriously ill, being hospitalized, and even dying,” the CDC official added.
There’s no evidence that the vaccines are effective against severe illness and death in young children.
Lack of Information
Zero cases of severe COVID-19 were recorded in Moderna’s trial for children aged 6 months to 5 years, including none in the placebo group. In Pfizer’s trial for children aged 6 months to 4 years, six of the seven cases of COVID-19 occurred in children who received a vaccine.
“The clinical trials were not powered to detect efficacy against severe disease in young children,” Dr. Sara Oliver, a CDC official, said during a meeting before the agency recommended the vaccines for young children.
Additionally, the endpoint of the trials was a certain level of antibodies, which are believed but not proven to be a way to protect against COVID-19. The level was based on the level from adults in the original trials, which were completed in 2020.
“The trials do nothing to inform us about symptomatic infection risk after Pfizer and show us efficacy is poor after Moderna and we don’t know how long any protection might last,” Dr. Tracy Hoeg, an epidemiologist in California, told The Epoch Times via email, adding that the trials “gave us no information about reduction of severe disease.”
The CDC, which bills itself as “the nation’s health protection agency,” says on its website that it has pledged to base all its decisions “on the highest quality scientific data that is derived openly and objectively.” Its officials have repeatedly said during the pandemic that the agency makes science-backed decisions.
The CDC was more circumspect earlier in 2022, the emails show. When asked to adjudicate whether claims were false, an official said that the agency “can’t speak to this until the pharmaceutical companies have reported data on vaccine efficacy against severe illness or death in the <5 year olds.”
‘Important Partnership’
“Thank you so much again for gathering the team to meet with us earlier this week, it was incredibly helpful. Your partnership is critical to us in making sure we can remove false and harmful claims about COVID-19 and vaccines on our platform,” a Facebook official wrote to the CDC in February.
“In follow up to our meeting, I am sharing below the long list of claims that we currently remove related to the COVID vaccine because public health authorities such as the CDC have confirmed they are false and could contribute to imminent physical harm if believed.”
Facebook still removes content that says the COVID-19 vaccines aren’t effective against severe illness or death, even though the effectiveness of the vaccines against both infection and severe disease has plunged since Omicron emerged in late 2021, particularly amid the newer Omicron subvariants.
“When we say that we will remove claims that the COVID-19 vaccines are not effective, we are specifically referring to claims that the vaccines do not generally protect against severe illness or death from COVID-19 or that they provide no protection whatsoever in contracting COVID-19,” Facebook says on its website. “However, we will allow claims that someone can still contract COVID-19 even though they are fully vaccinated.”
Facebook doesn’t cite the CDC on its site. It identifies some organizations whose advice it takes as fact, including the United Nations’ World Health Organization. It also says that it utilizes “government health authorities” in setting rules around COVID-19 content.
The CDC has been the source for reviewing many of the claims listed on Facebook’s site, according to the emails.
On Nov. 8, 2021, for instance, a CDC official reviewed seven claims and designated them all false. All seven are currently listed as false by Facebook.
That includes the claim that COVID-19 vaccines alter the immune system, which some experts say is true. It also includes the claim that COVID-19 vaccines alter people’s blood. At least one study has found many vaccinated patients have abnormal blood, while blood clots are a known COVID-19 vaccine side effect.
Facebook was “relying on your expertise” regarding whether certain side effects, including blood clots and Bell’s palsy, can be caused by COVID-19 vaccines, a Facebook official told the agency on Oct. 28, 2021, in another email.
Facebook wasn’t the only Big Tech company to rely on the CDC.
Twitter and Google asked the CDC to weigh in on claims surrounding COVID-19 and vaccines, the emails show.
On April 16, 2021, for instance, a Twitter official said its team “has asked for examples of problematic content so we can examine trends,” adding, “All examples of misinformation are helpful, but in particular, if you have any examples of fraud – such as fraudulent covid cures, fraudulent vaccine cards, etc., that would be very helpful.”
The CDC responded with a spreadsheet with four areas, including two related to vaccines.
One was the claim that the vaccines weren’t approved by the U.S. Food and Drug Administration. Regulators hadn’t approved any of the vaccines at that time; all were available under emergency use authorization. Another dealt with the Vaccine Adverse Event Reporting System, which is managed by the CDC and regulators. The spreadsheet, which hasn’t been released, explained how data from the reporting system was being “taken out of context,” the CDC said.
“Thank you so much for this; we actioned (by labeling or removing) the Tweets in violation of our Rules,” the Twitter official said.
Google, meanwhile, asked for help with claims on COVID-19 vaccines in spring 2020, the emails show.
A previous email release from a Freedom of Information Act request showed how the CDC regularly met with Big Tech companies as part of efforts to get them to crack down on misinformation.
Officials at Facebook, Twitter, Google, and the CDC didn’t respond to requests for comment.
Pattern of Misinformation
The CDC has incessantly promoted vaccination during the pandemic, and offered misinformation on a number of occasions while doing so.
Three top officials, including the agency’s director, falselysaid in June, while pushing for the vaccines to be authorized for young children, that COVID-19 was one of the top five causes of death for the age group. None have yet offered an update after the study they cited—which failed to accurately report CDC data—was corrected.
In a key update in August, the CDC rolled back recommendations to treat unvaccinated people differently, and acknowledged the protection a person receives from recovering from COVID-19.
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet to discuss the Company’s request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients at high risk for ARDS. The meeting is scheduled for October 06, 2022.
Physicians in Europe now have access to Penumbra’s latest stroke technology for mechanical thrombectomy
RED® reperfusion catheters are designed with optimized trackability and aspiration efficiency to help navigate the complex anatomy of the brain and deliver powerful aspiration for the removal of blood clots
Initial INSIGHT Registry data presented at WFITN demonstrated RED catheters were highly effective in removing all clot types with an impressive 68.9% mTICI > 2b-3 overall first pass effect rate
Almost half the people who were hospitalized with COVID-19 last spring had been fully vaccinated and received a third dose or booster shot, the Centers for Disease Control and Prevention says.
Unvaccinated adults were 3.4 times more likely to be hospitalized with COVID than those who were vaccinated, the CDC said.
The CDC report considered hospitalization numbers from March 20 to May 31, when the omicron subvariant BA.2 was the dominant strain. Researchers found 39.1% of patients had received a primary vaccination series and at least one booster or additional dose; 5% were fully vaccinated with two boosters.
"Adults should stay up to date with COVID-19 vaccination, including booster doses," the CDC said. "Multiple nonpharmaceutical and medical prevention measures should be used to protect persons at high risk for severe SARS-CoV-2, regardless of vaccination status."
Older adults and people with underlying medical conditions who become infected with the coronavirus are more likely to be hospitalized.
The study also found that hospitalization rates among people over 65 increased threefold over the study period. Rates among people under 65 rose 1.7 times.
Sources:
CDC: "Laboratory-Confirmed COVID-19–Associated Hospitalizations Among Adults During SARS-CoV-2 Omicron BA.2 Variant Predominance — COVID-19–Associated Hospitalization Surveillance Network, 14 States, June 20, 2021–May 31, 2022"
USA Today: "COVID this week: BA.5 boosters on the way, CDC reports hospitalizations among vaccinated, US life expectancy plunges"
A federal judge in Texas has ruled that parts of the Affordable Care Act mandating health insurance companies cover many preventive services and drugs for free are unconstitutional.
Judge Reed O’Connor also said the ACA’s requirement that health plans cover HIV pre-exposure prophylaxis, or PrEP, at no cost violates religious freedom law.
The decision, released Wednesday, is a temporary win for the plaintiffs, which include Steven Hotze, a physician and conservative activist who has campaigned against the ACA and previously called same-sex marriage a “wicked, evil movement.” The Department of Health and Human Services did not immediately say if it would appeal the decision, although an appeal is considered likely.
Under the ACA, health insurers are required to cover an array of preventive health services — like cancer screenings and vaccines — at no cost. In particular, any service or drug that gets an “A” or “B” rating from the U.S. Preventive Services Task Force must automatically be added to that list of free services.
However, the plaintiffs in this case argued they should not be compelled, as individuals or as business owners, to buy and offer coverage that includes “PrEP drugs, contraception, the HPV vaccine, and the screenings and behavioral counseling for [sexually transmitted diseases] and drug use.”
O’Connor specifically agreed that any services recommended by members of the USPSTF are invalid because those members “are unconstitutionally appointed.” Instead of being appointed by those within HHS, “they must be appointed by the President and confirmed by the Senate,” O’Connor wrote.
The specific requirement that health insurers cover PrEP drugs violates religious freedom, O’Connor said in his ruling. The plaintiff had previously argued that covering PrEP — which reduces the risk of getting the deadly infectious disease HIV, and which is widely prescribed to men who have sex with men and people who inject drugs — “would make him complicit in those behaviors.” O’Connor agreed.
The list price of brand-name PrEP drugs also is more than $22,000 annually. But O’Connor argued the government does “not show a compelling interest in forcing private, religious corporations to cover PrEP drugs with no cost-sharing and no religious exemptions.”
The requirements that insurers cover some kids’ services, reproductive services, and vaccines still stand for now.
This is not O’Connor’s first attempt at dismantling the ACA. Most recently, in 2018, he ruled the ACA was unconstitutional after Congress zeroed out the law’s individual mandate to purchase health insurance. The Supreme Court overturned O’Connor’s ruling in 2021.
