Novavax $NVAX Could Get EU Approval For COVID Vax Next Week

  • Post category:Biotechnology
  • Reading time:6 mins read
Get Email Alerts and Follow Us:
SOCIALICON

Novavax NVAX stock was up 4% in early trading on December 17, 2021, after FT reported that the company’s COVID vaccine could get EU approval as early as next week.

WHO, EMA could approve Novavax COVID vaccine next week, FT reports

The European Medicines Agency could approve the Novavax two-dose coronavirus vaccine as early as next week, paving the way for emergency use listing from the World Health Organization, Financial Times’ Donato Paolo Mancini reports, citing people familiar with the matter. The approvals would provide the drugmaker with a significant boost after months of delays and share price volatility amid manufacturing issues, the author notes. The COVID-19 vaccine, also known as Nuvaxovid, would be the company’s first marketed product after more than three decades in business. Source: https://ft.com/content/a938950e-7f97-46d6-a22c-6933c5634842

The story quickly turned into rumors that the EMA would approve the Novavax vaccine next week which is not exactly what FT published but you know what happens when the rumor mill kicks in.

Novavax says full results from PREVENT-19 COVID vaccine trial published in NEJM

Yesterday, Novavax noted that the full results from PREVENT-19, Novavax’ pivotal Phase 3 clinical trial of NVX-CoV2373, a recombinant protein nanoparticle vaccine against COVID-19, were published in the New England Journal of Medicine. “PREVENT-19 achieved its endpoint of efficacy in preventing polymerase chain reaction-confirmed, symptomatic mild, moderate or severe COVID-19 with onset at least 7 days after the second dose. The trial demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy against COVID-19 of any severity during the time period evaluated. Solicited adverse events were predominantly mild-to-moderate and transient. Severe reactions were infrequent and there were no safety concerns related to vaccination. PREVENT-19 evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in nearly 30,000 participants 18 years of age and older at 119 locations in the United States and Mexico. The trial included a blinded ‘crossover,’ ensuring all participants received NVX-CoV2373 without compromising Food and Drug Administration-required safety follow-up. Novavax expects to submit its complete CMC package to FDA for review by the end of 2021,” the company stated. Source: https://ir.novavax.com/Novavax-Statement-on-PREVENT-19-Phase-3-Clinical-Trial-Results-Publication-in-the-New-England-Journal-of-Medicine

Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine

On December 15, 2021, Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Company Limited (Takeda). Novavax’ recombinant nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, known as TAK-019 in Japan and NVX-CoV2373 outside Japan, is the first protein-based COVID-19 vaccine to be submitted under an NDA in Japan.

With the support of the MHLW, the companies are working to establish the capability to manufacture TAK-019 at Takeda’s facilities in Japan and aim to begin distribution in early 2022, pending regulatory approval.

“Today’s submission marks further progress in our quest to ensure broad global access to our protein-based COVID-19 vaccine,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Our partnership with Takeda reflects our shared commitment to tireless collaboration to deliver a COVID-19 vaccine, built on a well-understood vaccine platform.”

The NDA submission includes an interim analysis from Takeda’s ongoing Phase 1/2 immunogenicity and safety clinical trial of NVX-CoV2373/TAK-019 in Japan, in which the vaccine demonstrated a robust immune response and was well tolerated with no serious adverse events. Takeda submitted all available chemistry, manufacturing and controls (CMC), non-clinical and clinical data as of December 2021. Additional CMC data will be subsequently submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) during the NDA review period.

The application also includes safety and efficacy data from Novavax’ two pivotal Phase 3 trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulating variants of concern and variants of interest, and 90.4% efficacy overall; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.

📺 VIDEO Kim Iversen: NEW Novavax Vaccine Could Be The Answer To Jab Hesitancy

Kim Iversen details the new Novavax COVID-19 vaccine anticipated to hit the market soon.

Kim Iversen: NEW Novavax Vaccine Could Be The Answer To Jab Hesitancy

📈 NVAX Stock Technical Analysis

Nvax

Both the short-term and long-term trends are neutral. NVAX is one of the better-performing stocks in the Biotechnology industry, it outperforms 91% of 625 stocks in the same industry. Looking at the yearly performance, NVAX did better than 81% of all other stocks. However, this overall performance is mostly based on the strong move around 10 months ago. NVAX is currently trading in the middle of its 52-week range. The S&P500 Index however is trading in the upper part of its 52-week range, so NVAX is lagging the market slightly. Prices have been rising strongly lately, it may be a good idea to wait for a consolidation or pullback before considering an entry. NVAX has an average technical rating and it also does not offer a high-quality setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first. Click here to sign up for email alerts on when NVAX is a good entry.

Get Email Alerts and Follow Us:
SOCIALICON