An analysis of more than 1,000 research articles concluded that few health problems are caused by or clearly associated with vaccines.

The current measles outbreaks in the United States and elsewhere are being fueled by misinformation about the safety of vaccines.

Rick Bright, former director of the Biomedical Advanced Research and Development Authority, is seen here in 2018.; Credit: Toya Sarno Jordan/Bloomberg via Getty Images

Updated at 6:14 p.m. ET

The federal scientist who was ousted from his role as director of the Biomedical Advanced Research and Development Authority has filed a whistleblower complaint with the U.S. Office of Special Counsel.

Rick Bright was a high-ranking federal scientist focused on vaccine development and a deputy assistant secretary with the Department of Health and Human Services. Last month, Bright said he was transferred to a "less impactful position" at the National Institutes of Health after he was reluctant to promote the use of drugs such as hydroxychloroquine to treat COVID-19 patients.

In the complaint, Bright alleges a range of government wrongdoing by Dr. Robert Kadlec, the assistant secretary of preparedness and response at the U.S. Department of Health & Human Services, and others. Bright's boss was Kadlec, who in turn reported to HHS Secretary Alex Azar.

At the time of his removal, Bright said he had been ousted because of his "insistence" that the government spend funds on "safe and scientifically vetted solutions" to address the coronavirus crisis and not on "drugs, vaccines and other technologies that lack scientific merit."

Bright says in the complaint that he raised concerns about the need to prepare for the coronavirus in January but encountered opposition from Trump administration officials. He says he was transferred out of BARDA in retaliation.

According to the complaint, relations between Bright and Kadlec had been strained since 2018 or so, when Bright began "raising repeated objections to the outsized role Dr. Kadlec allowed industry consultants to play in securing contracts that Dr. Bright and other scientists and subject matter experts determined were not meritorious."

"Once the COVID-19 pandemic hit, however, Dr. Bright became even more alarmed about the pressure that Dr. Kadlec and other government officials were exerting on BARDA to invest in drugs, vaccines, and other technologies without proper scientific vetting or that lacked scientific merit," the complaint continues. "Dr. Bright objected to these efforts and made clear that BARDA would only invest the billions of dollars allocated by Congress to address the COVID-19 pandemic in safe and scientifically vetted solutions and it would not succumb to the pressure of politics or cronyism."

The complaint alleges that Bright made repeated efforts to get the U.S. government to make adequate preparations for coronavirus, but was stymied by political appointees leading the HHS, including Azar.

HHS did not immediately respond to NPR's request for comment.

Bright says that in an effort to get the word out to the public about the risks associated with hydroxychloroquine, he shared with a reporter nonclassified emails between HHS officials that "discussed the drug's potential toxicity and demonstrated the political pressure to rush these drugs from Pakistan and India to American households." He says Azar and Kadlec removed him from his post within days of publication of an article about chloroquine because they suspected he was the article's source.

Bright says he stopped receiving a paycheck on April 20 and has not been assigned any further duties.

News of the whistleblower complaint was made public by his attorney on Tuesday.

This content is from Southern California Public Radio. View the original story at SCPR.org.

Source: Streetwise Reports   04/22/2020

In an April 19 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that the Biomedical Advanced Research and Development Authority (BARDA) awarded Moderna Inc. (MRNA:NASDAQ) $483 million in funding, in part for development of its COVID-19 vaccine, mRNA-1273.

Rahimi discussed how Massachusetts-based Moderna will use the funds, which will be provided in tranches to reach certain milestones.

Half of the $483 million award will be used to help cover clinical development costs of mRNA-1273, from trial operations to the filing of a biologics license application.

Currently, the vaccine is in Phase 1 in the clinic. Recently, the biopharma decided to add to the study a cohort of patients aged 51 years and up, which "will be key for demonstrating mRNA-1273's safety and immunogenicity in this vulnerable population," Rahimi noted.

The analyst explained that for mRNA-1273 to advance to Phase 2, the results from Phase 1 must be optimal. The data must demonstrate the vaccine is safe and tolerable. They must show that the vaccine produced a sufficient number of neutralizing antibodies, crucial for stopping viral replication and proving the vaccine's method of action. Phase 1 safety data from the group aged 18–55 years are expected in spring followed by immunogenicity results, likely in mid-July or early August.

Rahimi relayed that as soon as safety data are available, Moderna plans to launch a Phase 2 study of mRNA-1273 rather than wait for the remaining results to become available, according to CEO Stéphane Bancel.

"Pending favorable safety data from Phase 1, we point out that a potential Phase 2 study would enroll hundreds of patients, and that the BARDA funding could potentially allow Moderna to pursue trials in patient populations who are at greater risk, such as patients who have underlying comorbidities, those who are overweight and patients with cancer," commented Rahimi.

Moderna will spend the second half of the $483 million BARDA funding on the engineering and optimization work required to scale up the manufacturing of its messenger RNA (mRNA).

"With the current focus on SARS-CoV-2 and mRNA-1273, Moderna was now able to present BARDA its strategic plans (amount, time and people) of how to be ready for commercial launch," wrote Rahimi. "This preparation was likely helpful in expediting discussions with BARDA and awarding of the grant."

Also regarding mRNA production, Ginkgo Bioworks, a company with expertise in organism biology and genetically engineering bacteria to replace certain industrial applications, is helping Moderna optimize certain parts of the process.

Rahimi, who is closely tracking COVID-19 data, highlighted that April 18 was the first day in five on which the daily death tally, 1,867, was less than that predicted by Dr. Christopher Murray's model, 2,194.

ROTH has a Buy rating on Moderna.

Disclosure:
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5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures from ROTH Capital Partners, Moderna Inc., Company Note, April 19, 2020

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Moderna, Inc.

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ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: MRNA:NASDAQ, )

Source: Streetwise Reports   05/06/2020

In a May 4 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Arcturus Therapeutics Holdings Inc. (ARCT:NASDAQ) formed a partnership with Catalent Inc. (CTLT:NYSE), which "raises the profile of LUNAR-COV19 as a leading vaccine candidate."

Arce reviewed Catalent's contribution to the partnership. The global contract development and manufacturing organization is to manufacture Arcturus' messenger RNA (mRNA) LUNAR-COV19 for protection against SARS-CoV-2 to be used first for human clinical trials and potentially, eventually commercially.

As for timing, Arce noted, San Diego, Calif.-based Arcturus intends to transfer its vaccine technology to Catalent this month and expects Catalent to manufacture the first batches of LUNAR-COV19 by June 2020. "Critically, Arcturus continues to anticipate initiation of Phase 1 testing of LUNAR-COV19 in the summer of 2020," Arce highlighted.

Catalent is to produce the vaccine at its biomanufacturing facility in Madison, Wisc. "This facility utilizes Catalent's flex-suite, a current good manufacturing practice manufacturing suite, that can produce batches at multiple scales and support Arcturus' proprietary mRNA manufacturing process," explained Arce.

Obtaining the vaccine from one facility domestically versus multiple entities worldwide should result in several benefits, Arce continued. They include easy development and production, accelerated delivery and improved costs. Arcturus believes Catalent can produce millions of doses of LUNAR-COV19 mRNA in 2020 and, if need be, hundreds of millions of doses each year subsequently for use globally.

Arce pointed out that LUNAR-COV19 differentiates itself from other similar vaccine candidates in that the technology and delivery platform behind it deliver an "extraordinarily low dose (perhaps 2 micrograms)" in "a potential single shot."

H.C. Wainwright has a Buy rating and a $62 per share price target on Arcturus, the stock of which is currently trading at about $42.12 per share.

Disclosure:
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3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures from H.C. Wainwright & Co., Arcturus Therapeutics Holdings Inc., First Take, May 4, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

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H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

( Companies Mentioned: ARCT:NASDAQ, )

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Civil Division (CIV)
Office of Vaccine Litigation
Washington, District of Columbia

Interns work closely with attorneys and paralegals on substantive matters in all stages of litigation. Indeed, the position offers a unique experience in public service. The legal and medical issues at stake in each case vary greatly. Attorneys and staff in the group handle heavy case loads, and while streamlined procedures are utilized, cases frequently involve complex liability and damages issues. The Group is obliged to ensure that the Vaccine Trust Fund, from which damage awards are paid, is protected and, where eligibility criteria are met, that fair compensation is distributed to those whom Congress has intended. Attorneys appear frequently before the U.S. Court of Federal Claims and before the U.S. Court of Appeals for the Federal Circuit, which affords interns the opportunity to gain experience in trial and appellate practice.

For the Fall semester, interns should be able to start in early September. For the Spring semester, interns should be able to start by early January. We accept both full and part-time students during the academic year, and ask that all interns commit to at least 16-20 hours a week, for approximately 12 weeks. Interested candidates may be offered the opportunity to continue their service into the Summer.

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Tags: coronavirus, New York Times, Stuart A. Thompson, vaccine

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The present invention relates to the development and manufacturing of viral vaccines. In particular, the invention relates to the field of industrial production of viral vectors and vaccines, more in particular to the use of avian embryonic stem cells, preferably the EBx® cell line derived from chicken embryonic stem cells, for the production of viral vectors and viruses. The invention is particularly useful for the industrial production of viral vaccines to prevent viral infection of humans and animals.

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