Tag Archives: Novavax

Efficacy of mRNA-1273 and Novavax ancestral or BA.1 spike booster vaccines against SARS-CoV-2 BA.5 infection in non-human primates – Science

  1. Efficacy of mRNA-1273 and Novavax ancestral or BA.1 spike booster vaccines against SARS-CoV-2 BA.5 infection in non-human primates Science
  2. PastoCovac and PastoCovac Plus as protein subunit COVID-19 vaccines led to great humoral immune responses in BBIP-CorV immunized individuals | Scientific Reports Nature.com
  3. Safety and immunogenicity of heterologous boosting with orally aerosolised or intramuscular Ad5-nCoV vaccine and homologous boosting with inactivated vaccines (BBIBP-CorV or CoronaVac) in children and adolescents: a randomised, open-label, parallel- The Lancet
  4. Study indicates that the Omicron wave and the rollout of vaccines led to almost 100% seropositivity and boosted anti-spike IgG titers in children and adolescents News-Medical.Net
  5. Protection against SARS-CoV-2 Omicron BA.4/5 variant following booster vaccination or breakthrough infection in the UK Nature.com
  6. View Full Coverage on Google News

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FDA authorizes emergency use for Novavax Covid-19 vaccine for ages 12 to 17

A box of the Novavax Covid-19 vaccine arranged at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.

Bloomberg | Bloomberg | Getty Images

Biotechnology company Novavax announced on Friday that its Covid-19 vaccine has been authorized for emergency use by the U.S Food and Drug Administration for adolescents between the ages of 12 and 17.

In July, Novavax’s two-dose Covid-19 vaccine for adults ages 18 and over got its emergency approval from the FDA.

Having more vaccine options for adults and children will “hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of Covid-19 with the start of fall and the back-to-school season,” Stanley C. Erck, president and CEO of Novavax, said in a statement.

Novavax was one of the original participants in the U.S. government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than rivals Pfizer or Moderna.

Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna.

How Novavax is different

The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA-approved vaccines to use mRNA.

Pfizer and Moderna’s vaccines use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a virus particle called the spike protein. The immune system responds to these copies of the spike, which prepares the human body to attack the actual virus.

Novavax makes copies of the virus spike outside human cells. The genetic code for the spike is put into an insect virus that infects moth cells, which produce copies that are then purified and extracted during the manufacturing process. The finished spike copies are injected into the human body, inducing an immune response against Covid.

The Novavax vaccine also uses an additional ingredient called an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broader immune response. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant.

Effectiveness and safety

Two doses of the Novavax vaccine were 90% effective at preventing illness from Covid across the board and 100% effective at preventing severe illness, according to clinical trial data from the U.S. and Mexico. However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant.

Novavax did not present any data on the shot’s effectiveness against the variant at the FDA committee meeting in June. However, the vaccine will likely have lower effectiveness against omicron as is the case with Pfizer and Moderna’s shots. Omicron is so distinct from the original strain of Covid that the antibodies produced by the vaccines have trouble recognizing and attacking the variant.

Novavax published data in December showing that a third shot boosted the immune response to levels comparable to the first two doses which had 90% effectiveness against illness. The company plans to ask the FDA to authorize a third dose of its vaccine.

FDA authorization of Novavax’s vaccines comes as the U.S. is preparing to update Covid shots to target the omicron BA.4 and BA.5 variants to increase protection against the virus. Novavax’s vaccine, like all the other shots, is based on the original version of the virus that first emerged in Wuhan, China. The effectiveness of Covid vaccines against mild illness has slipped substantially as the virus has evolved, though they still generally protect against severe disease.

Novavax presented data at an FDA committee meeting in late June demonstrating that a third dose of its vaccine produced a strong immune response against omicron and its subvariants. Committee members were impressed by the company’s data on omicron.

The Novavax vaccine also appears to carry a risk of heart inflammation for younger men, known as myocarditis and pericarditis, similar to Pfizer and Moderna’s shots. Myocarditis is an inflammation of the heart muscle and pericarditis is inflammation of the outer lining of the heart.

FDA officials flagged four cases of myocarditis and pericarditis from Novavax’s clinical trial in young men ages 16 to 28. People who develop heart inflammation as a side effect of Covid vaccines are usually hospitalized for several days as a precaution but then recover.

The FDA has issued a fact sheet for health-care providers warning that clinical trial data indicates there is an increased risk of myocarditis with the Novavax vaccine. People who experience chest pain, shortness of breath and feelings of a fluttering or pounding heart should immediately seek medical attention, according to the FDA.

In the case of the mRNA shots, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Myocarditis is usually caused by viral infections.

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COVID-19 Treatment, Novavax Vaccine Available in San Diego | News

If you get COVID-19, do you know there is treatment available that can keep you from getting severely sick?

There is. But you must act fast.

Antiviral pills and monoclonal antibodies should be given within days after the onset of symptoms to be effective. So, you should get tested for COVID-19 as soon as you start developing symptoms. If you are 12 or older and test positive and are at high risk of progressing to severe disease, contact your doctor immediately so that you can get treatment.

People with certain medical conditions are at high risk of developing severe COVID-19, including those with:

  • Age over 50 years
  • Asthma
  • Cancer
  • Chronic heart, lung or liver disease
  • Diabetes
  • HIV
  • Mental health and substance use disorders
  • Overweight or obese
  • Pregnancy
  • Smoking, current and former
  • Unvaccinated or not up to date on COVID-19 vaccinations
  • Other factors, like race and ethnicity

If you do not have a healthcare provider, you can call 2-1-1 to find one. You can also call a Monoclonal Antibody Regional Center at (619) 685-2500 to access monoclonal antibody treatment at no cost, regardless of health insurance or immigration status.

“Monoclonal antibodies and antiviral pills work great to keep people from developing severe COVID-19,” said Wilma J. Wooten, M.D., M.P.H., County public health officer. “If you’re at higher risk of developing severe illness, you should seek treatment immediately.”

Treatment centers and medical offices in the region may offer oral antiviral pills, which are taken by mouth, and/or monoclonal antibodies, which are delivered as an intravenous infusion. Your healthcare provider will determine what treatment option is best for you based on your symptoms, age and potential underlying conditions.

Novavax Vaccine is Available

Novavax, a more traditional vaccine against COVID-19, is now available in San Diego County.

You can get Novavax at local healthcare providers, retail pharmacies, and community clinics, as well as County public health centers and community vaccination events. You can make an appointment or find a walk-in clinic here.

Novavax has been authorized as a two-dose primary series, given three to eight weeks apart, to people ages 18 and older. Clinical trials showed that the vaccine series is 90% effective at preventing mild, moderate and severe COVID-19.

Everyone 6 months and older can get COVID-19 vaccines at no cost. For those who received an mRNA vaccine, boosters are available for people 5 years and older. Parental consent is required for all eligible minors to be vaccinated.

Vaccination Progress:

  • Received at least one shot: Nearly 3.01 million or 90% of San Diegans age six months and older are at least partially vaccinated.
  • Fully vaccinated: Nearly 2.66 million or 79.5%.
  • Boosters administered: 1,432,313 or 58.7% of 2,439,821 eligible San Diegans.
  • More vaccination information can be found at coronavirus-sd.com/vaccine.

Deaths:

  • 13 additional deaths were reported since the last report on Aug. 4, 2022. The region’s total is 5,437.
  • Of the 13 additional deaths, four were women and nine were men. They died between Jan. 21 and Aug. 7, 2022; six deaths occurred in the past two weeks.
  • Five of the people who died were 80 years or older, three were in their 70s, one was in their 50s and four were in their 40s.
  • Six were fully vaccinated and seven were not.
  • 12 had underlying medical conditions and one did not.

Cases, Case Rates and Testing:

  • 3,097 COVID-19 cases were reported to the County in the past three days (Aug. 8 to Aug. 10, 2022). The region’s total is now 898,520.
  • 7,045 cases were reported in the past week (Aug. 4 through Aug. 10) compared to 9,495 infections identified the previous week (July 28 through Aug. 3).
  • San Diego County’s case rate per 100,000 residents 12 years of age and older is 52.03 for people fully vaccinated and boosted, 34.81 for fully vaccinated people and 103.28 for not fully vaccinated San Diegans.
  • 6,748 tests were reported to the County on Aug. 6, and the percentage of new positive cases was 12.1% (Data through Aug. 6).
  • The 14-day rolling percentage of positive cases, among tests reported through Aug. 6, is 12.9%.

More Information:

Data updates to the County’s coronavirus-sd.com website will be published Mondays and Thursdays around 5 p.m., with the exception of holidays.

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COVID-19 Treatment, Novavax Vaccine Available in San Diego | News

If you get COVID-19, do you know there is treatment available that can keep you from getting severely sick?

There is. But you must act fast.

Antiviral pills and monoclonal antibodies should be given within days after the onset of symptoms to be effective. So, you should get tested for COVID-19 as soon as you start developing symptoms. If you are 12 or older and test positive and are at high risk of progressing to severe disease, contact your doctor immediately so that you can get treatment.

People with certain medical conditions are at high risk of developing severe COVID-19, including those with:

  • Age over 50 years
  • Asthma
  • Cancer
  • Chronic heart, lung or liver disease
  • Diabetes
  • HIV
  • Mental health and substance use disorders
  • Overweight or obese
  • Pregnancy
  • Smoking, current and former
  • Unvaccinated or not up to date on COVID-19 vaccinations
  • Other factors, like race and ethnicity

If you do not have a healthcare provider, you can call 2-1-1 to find one. You can also call a Monoclonal Antibody Regional Center at (619) 685-2500 to access monoclonal antibody treatment at no cost, regardless of health insurance or immigration status.

“Monoclonal antibodies and antiviral pills work great to keep people from developing severe COVID-19,” said Wilma J. Wooten, M.D., M.P.H., County public health officer. “If you’re at higher risk of developing severe illness, you should seek treatment immediately.”

Treatment centers and medical offices in the region may offer oral antiviral pills, which are taken by mouth, and/or monoclonal antibodies, which are delivered as an intravenous infusion. Your healthcare provider will determine what treatment option is best for you based on your symptoms, age and potential underlying conditions.

Novavax Vaccine is Available

Novavax, a more traditional vaccine against COVID-19, is now available in San Diego County.

You can get Novavax at local healthcare providers, retail pharmacies, and community clinics, as well as County public health centers and community vaccination events. You can make an appointment or find a walk-in clinic here.

Novavax has been authorized as a two-dose primary series, given three to eight weeks apart, to people ages 18 and older. Clinical trials showed that the vaccine series is 90% effective at preventing mild, moderate and severe COVID-19.

Everyone 6 months and older can get COVID-19 vaccines at no cost. For those who received an mRNA vaccine, boosters are available for people 5 years and older. Parental consent is required for all eligible minors to be vaccinated.

Vaccination Progress:

  • Received at least one shot: Nearly 3.01 million or 90% of San Diegans age six months and older are at least partially vaccinated.
  • Fully vaccinated: Nearly 2.66 million or 79.5%.
  • Boosters administered: 1,432,313 or 58.7% of 2,439,821 eligible San Diegans.
  • More vaccination information can be found at coronavirus-sd.com/vaccine.

Deaths:

  • 13 additional deaths were reported since the last report on Aug. 4, 2022. The region’s total is 5,437.
  • Of the 13 additional deaths, four were women and nine were men. They died between Jan. 21 and Aug. 7, 2022; six deaths occurred in the past two weeks.
  • Five of the people who died were 80 years or older, three were in their 70s, one was in their 50s and four were in their 40s.
  • Six were fully vaccinated and seven were not.
  • 12 had underlying medical conditions and one did not.

Cases, Case Rates and Testing:

  • 3,097 COVID-19 cases were reported to the County in the past three days (Aug. 8 to Aug. 10, 2022). The region’s total is now 898,520.
  • 7,045 cases were reported in the past week (Aug. 4 through Aug. 10) compared to 9,495 infections identified the previous week (July 28 through Aug. 3).
  • San Diego County’s case rate per 100,000 residents 12 years of age and older is 52.03 for people fully vaccinated and boosted, 34.81 for fully vaccinated people and 103.28 for not fully vaccinated San Diegans.
  • 6,748 tests were reported to the County on Aug. 6, and the percentage of new positive cases was 12.1% (Data through Aug. 6).
  • The 14-day rolling percentage of positive cases, among tests reported through Aug. 6, is 12.9%.

More Information:

Data updates to the County’s coronavirus-sd.com website will be published Mondays and Thursdays around 5 p.m., with the exception of holidays.

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Novavax, GoodRx, Allbirds and more

Take a look at some of the biggest movers in the premarket:

Novavax (NVAX) – The drugmaker’s stock plummeted 32.3% in the premarket after posting an unexpected quarterly loss and cutting its full-year revenue guidance in half. Novavax said it did not expect any further U.S. sales of its Covid-19 vaccine this year amid soft demand and a supply glut.

GoodRx (GDRX) – GoodRx soared 39.6% in premarket trading after the provider of prescription drug comparison software reported better-than-expected quarterly results, and also said an issue with a major grocery chain had been resolved.

Allbirds (BIRD) – The sneaker maker’s shares dived 11.8% in the premarket after it cut its full-year forecast, with the company saying external headwinds could pressure consumer spending in the back half of 2022.

Micron Technology (MU) – The chip maker said it expected negative free cash flow for the current quarter, as well as declines in revenue and profit margins. Chip shipments are falling due to weakening demand from PC and video game companies. Micron lost 3.7% in premarket action.

Take-Two Interactive (TTWO) – Take-Two fell 3.4% in the premarket after the video game publisher issued a weaker-than-expected revenue forecast. Take-Two is the latest company to see its results impacted by a general slowdown in gaming following a pandemic-era boom.

Occidental Petroleum (OXY) – The energy producer’s stock added 2.3% in the premarket following news that Berkshire Hathaway (BRK.B) had increased its stake in Occidental to more than 20%. That means that Berkshire can record part of Occidental’s profits as its own.

Signet Jewelers (SIG) – The jewelry retailer announced a deal to buy online jewelry seller Blue Nile for $360 million in cash. Signet shares added 2% in the premarket.

Upstart (UPST) – Upstart stock tumbled 12.2% in premarket trading after the cloud-based lending platform company missed Wall Street’s estimates on both the top and bottom lines for its latest quarter. It also issued a weaker-than-expected revenue forecast, saying that banking partners have turned more cautious due to the uncertain economy.

CarGurus (CARG), Vroom (VRM) – Both online used car sellers saw their stocks plunge in premarket action after reporting weaker-than-expected quarterly results. CarGurus sank 14.9% while Vroom slid 11.4%.

SoFi (SOFI) – The online financial services company’s stock fell 3.4% in premarket trading after Japan’s SoftBank said it would some or all of its 9% stake in SoFi.

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Stocks making biggest after hour moves: Novavax, Allbirds and more

A woman holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020.

Dado Ruvic | Reuters

Check out the companies making headlines after hours.

Novavax — The biotech stock dropped 32% after Novavax cut its full-year revenue guidance due to poor demand for its Covid vaccines.

Take-Two Interactive Software — Shares dropped 6% after the video game company behind titles such as Grand Theft Auto reported weaker-than-expected earnings. Take-Two reported $1 billion in revenue, less than the $1.09 billion projected by analysts surveyed by Refinitiv.

Upstart — Shares fell 7% after the consumer lending company posted disappointing second quarter results. Upstart earned 1 cent per share on revenue of $228.2 million. Analysts surveyed by Refinitiv were estimating earnings of 10 cents per share on revenue of $241.6 million.

Allbirds — The footwear stock dropped 12% after Allbirds cut its outlook for the year and announced cost-cutting efforts, citing weaker consumer spending. The footwear and apparel company otherwise beat expectations in its second-quarter results, compared with consensus estimates from Refinitiv.

Hims & Hers Health — Shares gained more than 4% after the telehealth company reported quarterly results and raised its full year outlook, citing continued momentum in the number of net new subscriptions.

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Why new Novavax Covid vaccine won’t win over unvaccinated Americans

Unvaccinated Americans will soon be able to opt for a new kind of shot to protect themselves from the ever-evolving Covid-19 virus: the Novavax vaccine.

The latecomer Covid shot has raised hopes of wider acceptance among vaccine skeptics. It uses traditional protein-based technology, unlike its mRNA counterparts. But experts say it still may not convince a large number of unwilling holdouts to roll up their sleeves and get vaccinated.

“I don’t think a shot like Novavax with well-worn technology is suddenly going to convince unvaccinated people to say, ‘Now, I want to get a vaccine, now I believe a vaccine will keep me out of the hospital and ICU,'” Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and member of an independent advisory group to the U.S. Food and Drug Administration, tells CNBC Make It. 

On Wednesday, the FDA authorized the Novavax shot for adults ages 18 and up. Once approved by the Centers for Disease Control and Prevention, it’ll only be available as a two-dose primary series, rather than a booster — which means only unvaccinated Americans will be able to receive it.

According to CDC data from early June, roughly 27 million U.S. adults still haven’t received a single Covid shot, posing a significant obstacle for American efforts to finally force Covid into a manageable, endemic phase. The U.S. is already grappling with yet another surge in Covid cases — this time, driven by highly transmissible omicron subvariants like BA.5 — and unless the country’s vaccination rate improves, a more severe variant of concern may soon emerge.

Here’s how Novavax’s Covid vaccine could help, and why many unvaccinated people might still pass on it.

The new vaccine’s appeal to people afraid of mRNA tech

The Novavax shot is the fourth Covid shot to earn FDA clearance in the U.S. and the first to use protein technology — a decades-old method of virus-fighting used in multiple routine vaccinations, like those against hepatitis B and shingles.

It’s highly effective, according to clinical data: Two doses were 90% effective at preventing illness from Covid when tested in a study involving about 30,000 adults ages 18 and older, according to the FDA. Notably, the research was conducted from December 2020 through September 2021, a few months before the emergence of Covid’s omicron variant.

Novavax’s shot works differently than its mRNA counterparts, but achieves the same outcome: teaching your body how to fight Covid. It injects copies of the spike protein — a molecule found on the coronavirus — and an ingredient called adjuvant into your body’s cells, which induces an immune response to the virus.

“Novavax essentially uses the same approach as mRNA vaccines, but they make the protein in a factory. So they’re giving you the protein itself, rather than instructions for your cells to make a protein,” says Dr. Robert Schooley, an infectious disease specialist at UC San Diego Health.

Guy Palmer, a professor of pathology and infectious diseases at Washington State University, says the Novavax vaccine could potentially appeal to Americans who falsely believe that mRNA vaccines are unsafe, due to the technology’s perceived newness and a misconception that they could alter human DNA.

“There’s a slight open door there for a non-mRNA vaccine like Novavax,” Palmer says.

Vaccine denialism is a cultural issue 

Unvaccinated Americans may perceive protein-based shots as safer than mRNA ones: In a Morning Consult poll last week, about 28% of unvaccinated people surveyed said they viewed protein-based shots as safe, while only 17% said the same about mRNA vaccines.

But 77% still said they wouldn’t get a protein-based Covid shot if it were authorized in the U.S.

Offit points to a larger problem at hand: Vaccine denialism has become a cultural issue, no matter the technology behind the shots. He says many unvaccinated Americans, especially those who are politically right-leaning, are now fueled by hardwired ideas like government distrust.

In a Kaiser Family Foundation poll released in May, only 14% of Republicans surveyed said they had a “great deal or fair amount of trust” in President Joe Biden to provide reliable information about Covid vaccines. The poll also notes that Republicans are among those with the lowest vaccination rates, at just 55%.

Even today’s most common anti-vaccination argument — that the vaccines are pointless, because they can’t always prevent breakthrough infections — may be a cover for those types of hardwired ideas. (No vaccine is ever 100% effective, and staying up-to-date on your Covid vaccines can significantly lower your chances of severe illness, hospitalization or death.)

“Some say they don’t want an mRNA vaccine, so this protein vaccine can be an alternative. But other people might say I just don’t like vaccines, period. Or I don’t trust the FDA or the government,” Schooley says. “Providing rational explanations and alternatives like Novavax that address some concerns doesn’t necessarily get you past the fact that there’s just an aversion to being vaccinated.”

The Novavax vaccine is still good news

The shot’s entrance into the U.S. market could still be good news, says Dr. Dean Blumberg, chief of the division of pediatric infectious diseases at UC Davis Health.

Another source of vaccine supply is “always good to have” in case other companies have manufacturing difficulties, Blumberg says. It can ensure that an event similar to the recent baby formula shortage won’t happen with Covid vaccines, he adds. 

Blumberg also emphasizes that any progress in getting holdouts vaccinated should be celebrated. 

“I’m not sure how many of the remaining unvaccinated people in the U.S. are going to be interested in getting this Novavax vaccine — but it’s one more tool in the toolbox,” he says. “Even if just a few people take advantage of getting vaccinated with it, that’s great.”

Offit says Novavax may have a larger impact down the road: Its omicron-specific booster shots may be ready for federal approval this fall or winter, and pre-clinical data shows they could potentially provide enhanced immunity against omicron and its subvariants.

“You have a certain part of the population that is clearly interested in getting as many doses as possible,” Offit says, adding that people could view a Novavax booster as “an advantage” over a shot that’s the same as their previous doses.

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U.S. FDA authorizes Novavax COVID vaccine for adults

July 13 (Reuters) – The U.S. Food and Drug Administration authorized the use of Novavax Inc’s (NVAX.O) COVID-19 vaccine on Wednesday, clearing the way for a shot whose more traditional technology has raised hopes of wider acceptance among vaccine skeptics.

Shares of Novavax rose 1.3% to $70.89 after its two-dose vaccine became the fourth COVID shot to be authorized for use in adults in the United States.

The U.S. Centers for Disease Control and Prevention (CDC) still needs to sign off on the use of the vaccine before it can be made available to people.

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A panel of CDC advisers on vaccines is expected to meet on Tuesday, but the agenda has not been released yet.

Earlier this week, the U.S. government said it had secured 3.2 million Novavax vaccine doses, which it plans to release once the company finishes quality testing in the next few weeks.

More than two-thirds of the U.S. population has been fully vaccinated with shots from Moderna Inc (MRNA.O), Pfizer-BioNTech , or Johnson & Johnson (JNJ.N).

U.S. health officials hope that people who have opted not to take Pfizer and Moderna’s vaccine, which are based on the groundbreaking messenger RNA (mRNA) technology, will instead opt for Novavax’s protein-based shot.

The vaccine, already approved in Europe, is based on a technology that has been used for decades to combat diseases including hepatitis B and influenza.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards,” FDA Commissioner Robert Califf said in a statement.

In Europe, however, demand for the shot has not been significantly high, with about 242,000 doses of the vaccine administered since its launch in December, prompting Novavax to increase its focus on lower-income countries.

The company’s initial application for U.S. authorization of the shot was delayed by almost a year on development and production problems, making it a late entrant in the country’s market for COVID vaccines.

Novavax has projected between $4 billion and $5 billion in sales this year. Analysts expect sales at the lower end of that range, according to Refinitiv.

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Reporting by Manas Mishra and Mrinalika Roy in Bengaluru;
Editing by Vinay Dwivedi and Devika Syamnath

Our Standards: The Thomson Reuters Trust Principles.

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Novavax: FDA gives emergency use authorization to Covid-19 vaccine

Novavax’s vaccine will be available as two-dose primary series for people 18 and older.

The FDA’s independent Vaccines and Related Biological Products Advisory Committee voted in favor of authorization of the vaccine June 7, saying that the benefits of the vaccine outweigh its risks for adults. It is also being used in 170 other countries.

The shots can’t be administered until the US Centers for Disease Control and Prevention’s independent vaccine advisers weigh in on whether to recommend the vaccine and the CDC director has signed off on the recommendation. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet July 19.

Like more familiar vaccines such as hepatitis B and pertussis, the Covid-19 vaccine is protein-based, using harmless protein fragments of the virus to teach the immune system how to spot the virus and fight it off. The vaccine was created out of a genetic sequence of the first strain of the coronavirus.

Unlike some other Covid-19 shots, Novavax’s vaccine can be stored in standard refrigeration.

About 1 in 3 Americans has still not been vaccinated against Covid-19, more than 100 million people. Many officials and health care workers hope that a vaccine like Novavax’s, which uses more familiar technology, may be enough to persuade people who’ve been hesitant to get inoculated.

“We believe that some portion of those 100 million people are waiting for our vaccine. And if you look at my in-basket, every day as I come to the office, you’ll see that there are quite a few of those people who are who are saying ‘let’s get this vaccine approved. I want it.’ So I don’t know what the what the portion of that 100 million people is, but but I think it’s not insignificant,” Novavax President and CEO Stanley Erck told CNN.

In addition to the primary series of shots, he says, the company hopes to receive authorization soon to use its shots as boosters to other vaccines.

“We’ve talked with the FDA quite a bit about this,” Erck said. “I believe the FDA will be addressing that approval within weeks.”

Late-stage trials found that the efficacy of the vaccine against mild, moderate and severe disease is 90.4%, according to the company. There is not sufficient evidence to evaluate the impact of the vaccine on transmission of the virus.

Novavax also announced in early July that its vaccine shows “broad” immune response to currently circulating variants, including Omicron subvariants BA.4/5.

Novavax’s vaccine was developed with funding from the federal government’s Operation Warp Speed.

On Monday, the Biden administration announced that it had secured 3.2 million doses of the Novavax vaccine.

The company said Wednesday that it expects the vaccine to be available quickly, pending signoff from the CDC.

“We have vaccine that we’ve manufactured for the US. It is shipped and waiting in the warehouse,” Erck said. “The government has been very anxious to get these doses into their distribution system.

“My anticipation is that it will get widely distributed quickly.”

Erck also said the company was planning to offer vaccines to adolescents and children as young as 2 years. Data on the efficacy of kids’ shots will be available “in the coming months,” and Novavax hopes to offer shots to children later this year.

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Novavax Stock: Your Friendly Reminder To Cash Out (NASDAQ:NVAX)

donfiore/iStock via Getty Images

Investment Thesis

With Politico reporting the potential approval of NVX-CoV2373 by the US FDA on 13 July 2022, this is a friendly reminder for those looking to cash out the Novavax, Inc (NASDAQ:NVAX) stock. The time is finally near, though admittedly much slower than expected since NVAX had submitted for US regulatory approval since 31 January 2022. The approval process for its vaccine has been oddly drawn out, given the swift approvals granted to its competitors, such as Pfizer (PFE) and Moderna (MRNA), for the youngest age group. Nonetheless, we are not here to speculate on the US FDA’s reasons, since there are more significant problems here.

Though we still believe in the NVAX vaccine’s efficacy and its traditional protein subunit technology, its management has proven to be slower than expected in getting any of its products approved by the US FDA. In addition, there is no further news from its global supply chain/ manufacturing plants, potentially due to the “destruction of demand” for most COVID-19 vaccines, with PFE already feeling the heat.

As the NVAX bulls continue to say, some could be holding out for its more traditional vaccine and/or its combined COVID/ Flu shot. However, we are less hopeful for now. We believe that these vaccines need to be approved first, before we can glean any real-life data and global demand, before justifying NVAX’s current premium.

Still, Minimal Novavax Vaccine Deliveries

Ministry of External Affairs in India

By now, NVAX has only shipped 157.01M vaccines out from its manufacturing partner’s facility in India, Serum Institute of India. Though the US government had also ordered 3.2M doses contingent on the US FDA approval, these numbers are far lower than the original APA of 110M doses as part of its $1.8B funding commitment. Now that is somewhat underwhelming, since a similar “demand destruction” was reported in the EU with only 90.4M doses of NVX-CoV2373 delivered out of 400M APAs.

With the US FDA requesting Omicron-specific vaccines, NVAX would be late again, with its clinical trials/ results only released by the end of Q3’22. In the meantime, Moderna had released satisfactory results for its Omicron-specific vaccines by 22 June 2022, with Pfizer also announcing its findings on 25 June 2022. Therefore, given the historical speed of the US FDA’s approval and their manufacturing prowess, we expect Pfizer and Moderna to win the upcoming race as well, potentially leaving NVAX in the dust.

As for the combined COVID-19/ Flu shot, NVAX may potentially stand on the global stage, since Pfizer’s and Moderna’s pipelines are either still in the pre-clinical stage or Phase 1. However, it also remains to be seen when its NanoFlu will be approved, despite the excellent clinical trial results since March 2020 and the appointment of a new leadership team specific to NanoFlu in October 2020. Frustrating, to say the least, given the annual global demand for Influenza shots worth $6.59B in 2021.

NVAX Underperformed In The Show-Me-The-Money Game

S&P Capital IQ

NVAX has been underperforming in its financial segment in the past few quarters, despite the previous hype. However, it is also essential to note that the company finally reported positive net income profitability of $0.2B from revenues of $1.53B in FQ1’22, indicating a net income margin of 13% then. Not too bad for starters, indeed.

Nonetheless, it is also apparent that NVAX has yet to generate positive Free Cash Flows (FCF), with -$0.11B of FCF and -15% of FCF margins in its latest quarter, a vital point for its future expansion, pipeline research, and R&D efforts. As a result, the company could potentially rely on more debt and share dilution for its future capital, as highlighted in our previous analysis.

S&P Capital IQ

Since our previous analysis, NVAX’s projected revenue and net incomes have fortunately remained broadly in line, with a similar tapering by FY2024. Analysts will also be closely watching its FQ2’22 performance on 4 August 2022, with consensus revenue estimates of $1.02B and EPS of $5.54, indicating a YoY improvement of 241.2% and 85.7%, respectively. Given NVAX’s deliveries of approximately 58M doses in FQ2’22, there might be a chance for stock recovery post the FQ2’22 earnings call, since it represents a 41.4% increase in delivery QoQ. We shall see.

In the meantime, we encourage you to read our previous article on NVAX, which would help you better understand its position and market opportunities.

  • Novavax: Sell To The U.S. FDA Rally And Say Goodbye
  • Novavax: Avoid This Cancer At All Costs

So, Is NVAX Stock A Buy, Sell, Or Hold?

NVAX 5Y EV/Revenue and P/E Valuations

S&P Capital IQ

NVAX is currently trading at an EV/NTM Revenue of 1.09x and NTM P/E of 3.64x, lower than its 5Y mean of 24.95x and 5.06x, respectively. However, who are we kidding? The stock’s valuation was never really in the picture, since it moves mostly on investors’ sentiment and news. As of 12 July 2022, the stock is trading at $69.76, down 74.8% from its 52 weeks high of $277.8, though at a premium of 200% from its 52 weeks low of $34.88. The stock has also rallied by 33.36% from our previous analysis, from $52.31 on 8 June 2022 to $69.76 on 12 July 2022, making all NVAX investors happy, especially those looking for a higher exit point.

NVAX 5Y Stock Price

Seeking Alpha

Therefore, given the multitude of reasons above, we are not convinced of the consensus estimates’ attractive buy rating with a price target of $126.50 with an 81.34% upside. We will be lucky to see the stock reach $100 in the next few weeks ( post US FDA approval and FQ2’22 earnings call ), providing a comfortable cushion for those looking to cash out. As for the bulls, I love your enthusiasm, really, since I was a believer too before the management disappoints. It might be interesting to see how NVAX performs in FQ2’22, since we might be feeling a little hopeful again. Good luck to all!

Nonetheless, we still reiterate our sell rating for the NVAX stock, upon the upcoming rally post US FDA approval.

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