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Stille

Some interesting developments,

First Novavax vaccine trials ran during the UK, South Africa, Brazilian strains, and the exact data is not known yet, expect it to be significant and how UK citizens will need another vaccine. Biontech & Moderna’s mRNA vaccine can be adjusted very quickly, but conventional vaccines cannot.

Janssen Pharmaceutical ran the trials in the UK, South Africa, amongst other countries, they are owned by Johnson Johnson.
The Data is impressive on Severe Covid disease; it proved it efficacy rate of 85%, so its new data that AZN don’t have, due to them not concluding trials during this period.
On moderate Covid disease, it’s efficacy rate is 58%, so it combination of 66% efficacy is on the known strain of Covid 19, but scores high on the virulent strains of UK, South African ,the 85% Efficacy figure on UK & South African strains could be marker. We will have to wait on the FDA to analyze the data to get a clear picture.

Novavax, up scaling production will be interesting, I suspect Sanofi will step in and assist. GSK may, but contractual agreements with Medicago and Clover Pharma may limit them.
One issue many observes or analysts have not picked up to date, is that GSK have moved the Malaria Vaccination Production to Bharat Biotech of India, this frees up manufacturing and production, which equates to 26000 Vaccine doses daily now available, this could be a signal GSK will assist with say Novavax, if contractual agreements allow.
Biontech, already have Sanofi working on production with them for the EU and Covax. I am always at a loss how UK/US TV commentators refer to the Vaccine as Pfizer, its Biontech GERMAN

This is the 3rd separate Trail its being conducted in the UK, its only 2 weeks in.
https://investors.vir.bio/news-releases/news-release-details/vir-biotechnology-and-gsk-announce-nhs-supported-agile-study

Finnaly, the 4th trail announced Wednesday is using GSK/VIR/ELI Lilly antibodies, so the end result todate is thus, if none of these GSK/VIR Antibody worked, then they would have been scrapped.

Its likely that EUA as been granted already in the USA , why else would they have 4 trails in place, all are doing well IMO, or they would not running still

Multi trails on going.
Its already in the ACTIV 3 phase trail .
If you read the below, its also in a further trail, we are 6 weeks in and its gone fro being trailed on moderately Ill Patients to severely Ill patients, so rapidly moving forward in 3 trails
See Below
In addition to the Phase 3 ACTIV-3 trial, VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization. The Phase 3 part of the COMET-ICE trial is assessing the safety and efficacy of a single intravenous (IV) infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of adults who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. The COMET clinical development program for VIR-7831 also includes a planned Phase 3 trial for the prevention of symptomatic infection.

GSK set out to get 3 major approvals in this last financial year, they got 4, 3 oncology treatments, including break -through Zejula, which is unique and no other pharma company as this or is likely to in the next 3 years.
It got its HIV approved , and achieved it by keeping 98% of trail participants enrolled in the trail during a pandemic, this on its own is astonishing.
GSK actuay paid all transportation costs to get the HIV participants in on schedule which was a logistical challenge during the Pandemic.

Point of interest.
GSK were expecting to close on the sale of Horlicks to Unilever and divestment in Horlicks Hindustan for £3.1 billion, but due to how they divested in Horlicks Hindustan shares, they actually achieved £3.4 billion.

Johnson Johnson already have made 100 million doses, they are ready to go in the USA on Approval, they can produce volumes quickly, the vaccine as been made in the USA since it went phase 3, they made it as they went along , like GSK and Sanofi did.
GSK have two others in Phase 3, as well as reworking the Sanofi Vaccine, due to it being not effective in Older people.

Biontech
Moderna
all have the ability to modify vaccine as changes are seen in the Virus, due to them not using a live virus that AZN/JJ have used

It's Good NVAX held it gains, looks like the US is pricing the shares fairly , and its taking account of the Warp speed payment of $1.6 billion Be interesting when the Next German Vaccine comes through.
Looks like they are gearing up , prospectus on funds looks good and with Elon Musk in with them on a level of technical and manufacturing

I assumed a lot was priced in, but great call Stelle
$7.05 a year ago
https://www.nasdaq.com/market-activity/stocks/nvax
Edged or flew above $200

papucel, you show what a vile individual you are , nothing was addressed to you.

You are simply a vile toxic person who can not handle facts.
Grow up

Stillie.
It's a shame that people can not accept that German Technology that brought about a mRNA vaccine is showing through
CVAC pioneered this technology in 1998, before they went into it with substantive funding and technology. In 1998 they shared the data with a little known company, that went onto be owned by Acuitas.

The Liposome which is a lipid , a spherical pliable structure, was first discovered in Germany in 1963, obviously science moves on and technology as , which is part of the mRNA.
Biontech had the know and where about to bring it to the forefront, and CVAC had pioneered the first mRNA in a different vaccine for a specif disease.

I would not have a AZN/Oxford vaccine, it does not suit all people , and if the UK NHS is only offering AZN based on supplies and CCG in the area of the UK, people can request Biontech based on existing conditions they have.

All vaccines given to people should be given with a dosage detail and batch number detail to the person receiving it, I have no doubt if people ask they will get it, but it should be given.

The UK does not have enough Immunologist's and it's rare people ever see one, be interesting if the UK did full immunology testing

AZN trails did not include over 65's, they did not run the trials with them in it, saying they were insufficient numbers.
Thats where the EU and German and USA stance will be.

Its a legal requirement that each person is told what vaccine they recieve and should be issued with the dosage given and the batch number of the vaccine, the reason is so any side effects can be traced back to see if its a fault within the batch first.

My elderly relative in the UK had both doses of Pfizer vaccine, no effects , no aches or such, which is good, hope they all are the same

WHO say it will take atleast two years to vaccinate the wealthy nations and the set backs will come for vaccine manufacturing companys like AZN, JJ, Pfizer.

If GSK come through with Medicago, then its a new era dawning, but that is not for today

Yes have the Mianz company still, somethings you dont Sell

NVAX, only concern is if it does not come up with good efficacy, the stock as a lot priced in.
On the upside is NVX-CoV2373 trails in South Africa the trails would pick up variants and over 250 HIV positive volunteers have been in the trail, which is something new

Sheungy,
If Regulatory filing s are made and incorrect or missing data, of course investors have the right to know.
What's more the EU invested 330 million euros in AZN for vaccine plants, the USA gave AZN Oford $1.2 billion, taxpaerys in bother USA and the EU can question anything, its not a blank check.
The UK only stumped up £88 million , that says it all .

If you were a regulatory officer of a pension fund or responsible for Corp Governace, you would be required to make sure everything is beyond question.

SEC regulations have to be followed

The plaintiff, Monroe County Employees’ Retirement System, an AstraZeneca shareholder, filed the complaint on January 26, 2021 in the Southern District of New York against the company and certain of its directors and officers purportedly on behalf of a class of investors who purchased AstraZeneca’s American Depositary Shares (ADSs) between May 21, 2020 and November 20, 2020. The complaint alleges that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder.

(f) that, as a result of (a)-(e) above, the clinical trials for AZD1222 had not been conducted in accordance with industry best practices and acceptable standards and the data and conclusions that could be derived from the clinical trials was of limited utility; and

(g) that as a result of (a)-(f) above, AZD1222 was unlikely to be approved for commercial use in the United States in the short term, one of the largest potential markets for the drug.

On November 23, 2020, AstraZeneca announced the results of an interim analysis of its ongoing trial for AZD1222. Though the press release claimed that the vaccine candidate had met its primary endpoints, the announcement, according to the subsequently filed securities class action lawsuit complaint, “immediate began to raise questions among analysts and industry experts.” Among other things, the results show that one of the clinical trials inexplicably provided patients with only a half dose of the vaccine, followed by a full dose. Confusingly, the company, according to the complaint, claimed that the half dosing regimen was “substantially more effective at preventing COVID-19 at 90% efficiency than the full dosing regimen, which had achieved just 62% efficiency.”

The complaint alleges that the “unexplained discrepancies, omissions and the need for multiple trials in separate locales raised red flags for investors and distinguished AstraZeneca’s trial procedures from those of other biopharmaceutical companies.” The company, the complaint alleges, “hastily put out statements defending its interim analysis and held conference calls with analysis covering the Company,” although the responses “raise more questions than answers and cast further doubt on the integrity of the trials’ design, data and conclusions.” The complaint alleges that the company’s share price declined 5% over three trading days by the end of trading on November 25 in response to the adverse news.

The complaint alleges that the company’s various communications leading up to the news of the mixed clinical trial results on November 23 were false and/or misleading because the communications failed to disclose that:
(a) that initial clinical trials for AZD1222 had suffered from a critical manufacturing error, resulting in a substantial number of trial participants receiving half the designated dosage;

(b) that clinical trials for AZD1222 consisted of a patchwork of disparate patient subgroups, each with subtly different treatments, undermining the validity and import of the conclusions that could be drawn from the clinical data across these disparate patient populations;

(c) that certain clinical trial participants for AZD1222 had not received a second dose at the beginning of the designated time points, but rather received the second dose up to several weeks after the dose had been scheduled to be delivered according to the original trial design;

(d) that AstraZeneca had failed to include a substantial number of patients over 55 years of age in its clinical trials for AZD1222, despite this patient population being particularly vulnerable to the effects of COVID-19 and thus a high priority target market for the drug;

(e) that Astra-Zeneca’s clinical trials for AZD1222 had been hamstrung by widespread flaws in design, errors in execution, and a failure to properly coordinate and communicate with regulatory authorities and the general public;

In what is the third coronavirus-related securities class action lawsuit filed so far in 2021, a plaintiff shareholder has filed a securities class action lawsuit against the U.K.-based biopharma firm AstraZeneca plc relating to the setbacks the company encountered late last year in connection with the company’s efforts to develop a COVID-19 vaccine. The complaint also relies heavily on the way that the company communicated to investors and the general public concerning anomalies in the vaccine’s interim clinical trial results
AstraZeneca is a multinational biopharmaceutical company headquartered in the U.K. After the coronavirus outbreak became widespread in early 2020, AstraZeneca was one of several pharmaceutical companies to become involved in efforts to develop a COVID-19 vaccine. As part of its effort, the company partnered with Oxford University. In a series of press releases during 2020, the company detailed its efforts to develop the vaccine and described the company’s clinical trial program in support of its efforts. AstraZeneca’s vaccine candidate was known as AZD1222.

In a May 21, 2020 press release, the company announced that it had received substantial governmental commitments to develop its vaccine candidate and noted that the previous month the company had begun a Phase I/II clinical trial. Among other things, in its May 21 press release, the company said that if the early stage trial results were positive, it could “lead to late-stage trials in a number of countries,” although it also said that the company “recognizes that the vaccine may not work but is committed to progressing the clinical trial program with speed and scaling up manufacturing at risk.”

In a July 20, 2020 press release, the company said that the early stage trials had shown positive results – the tests showed that the vaccine “tolerated and generated robust immune responses against [COVID-19] in all evaluated participants.” In various subsequent press releases, the company provided further detail about its ongoing clinical trial efforts, reiterating that the company was committed to “the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance.” On August 31, 2020, the company announced that it was expanding the U.S. clinical trials of its vaccine candidate to Phase III, and the company published several subsequent updates detailing its clinical trial efforts and reiterating the company’s commitment to safety and efficacy.

Miss leading statements in a regulatory filing is up to the "SEC" to rule on, if they find miss leading statements and are " ASKED" to investigate, then it must be substantive proof of miss leading.

The case does not all rely on the CEO saying one thing, it will take into account the Regulatory statements

GSK is shifting production of its malaria vaccine to a Covid-19 vaccine developer in India.

Wednesday’s move to Bharat Biotech was made as part of efforts to battle the deadly fever, as GSK’s vaccine is the first to prove effective in combating the disease. Bharat will take over manufacturing of the protein part of the vaccine while GSK continues developing the adjuvant portion of the shot.

The vaccine is currently being piloted in regions of Ghana, Kenya and Malawi under the Malaria Vaccine Implementation Program. More than 500,000 children have received the first dose since the pilots were initiated by the three countries in 2019.

GSK has committed to providing 10 million doses for the pilot programs and 15 million annually through 2028. The companies expect that by 2029, Bharat Biotech will take over as the sole supplier of the vaccine while GSK continues to provide the adjuvant.

According to the WHO, there were 229 million cases of malaria worldwide in 2019, with 94% of cases and deaths occurring in Africa.

Ted Baker is lightening up for fall, thanks to the vision of its new global creative director.

Anthony Cuthbertson, whose résumé includes Topshop, Roberto Cavalli, Sass & Bide, Rene Lezard and Burlington/Ralph Lauren, among others, joined the U.K.-based brand last fall. For his first full collection, Cuthbertson offered up a more-relaxed and cozy assortment intended to address those working from home and trying to navigate a seemingly endless pandemic.

“We’re rewriting the codes to make them more relevant to today,” Cuthbertson said in an interview from his London studio. “We’re bringing more casualization to everything we do.”

Ted Baker has built its reputation on offering more-tailored pieces in an array of bright prints. But while there’s still some of that in the collection, the new direction is broader and much less formal, and offers an expanded assortment of outerwear, knitwear and accessories.

“The brand has some great history,” he said, adding that is a quintessential British label that has historically brought “a bit of humor” to its offering. But the Britain of today has changed and Cuthbertson has created a collection intended to blend “modern references and nostalgia.”

“For me, there’s a juxtaposition of art, e-commerce and fashion. Ted was always at the forefront of that,” he said. “And we want to bring that back.”