(Bloomberg) — The dollar may tumble to its lows of 2018 on the rising likelihood of Joe Biden winning the U.S. election and progress on a coronavirus vaccine, according to Goldman Sachs Group Inc.

“The risks are skewed toward dollar weakness, and we see relatively low odds of the most dollar-positive outcome — a win by Mr. Trump combined with a meaningful vaccine delay,” strategists including Zach Pandl wrote in a note Friday. “A ‘blue wave’ U.S. election and favorable news on the vaccine timeline could return the trade-weighted dollar and DXY index to their 2018 lows.”



chart, histogram: Hedge funds turned bearish on the greenback for first time since 2018 in August


© Bloomberg
Hedge funds turned bearish on the greenback for first time since 2018 in August

The ICE U.S. Dollar Index has fallen almost 3.5% this year — trading just over the 93 level on Monday — as investors reacted to unprecedented pandemic-related monetary stimulus from the Federal Reserve and rock-bottom interest rates. The gauge traded below 89 in 2018, a level which would imply a further slide of more than 4%.

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Goldman joins the likes of UBS Asset Management and Invesco Ltd. in predicting a weaker dollar as Biden extends his lead over President Donald Trump with less than three weeks to election day. It recommends investors short the dollar against a volatility-weighted basket consisting of the Mexican peso, South African rand and Indian rupee.

The strategists also suggest buying the euro, Canadian and Australian dollars against the greenback. The firm is keeping open long recommendations for the yuan through unhedged Chinese government bonds.

“The wide margin in current polls reduces the risk of a delayed election result, and the prospect for near-term vaccine breakthroughs may provide a backstop for risky assets,” they wrote.

Read more: Trump-Biden Volatility Is Giving Traders Butterflies: QuickTake

(Updates pricing in third paragraph.)

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An engineer works in the general laboratory during a media tour of a new factory built to produce a COVID-19 coronavirus vaccine


WANG ZHAO/AFP/Getty Images

A briefing document published today by the U.S. Food and Drug Administration makes it clear that President Trump won’t be able to push through a Covid-19 vaccine before November’s election.

The FDA posted the 38-page briefing on its website, ahead of an Oct. 22 meeting of the agency’s outside scientific advisors on development and authorization of Covid vaccines. Inside, the agency reports that it has advised vaccine developers not to apply for an emergency use authorization until they’ve followed-up on clinical trial participants for an average of two months after the last shot.

A two month follow-up would make it late November for the vaccine being tested by

Pfizer

(ticker: PFE) and

BioNTech

(BNTX), writes Raymond James analyst Steven Seedhouse in a Tuesday note. That vaccine had been regarded as the front-runner, with a clinical trial design that Pfizer executives thought would yield an answer before October’s end.

But Seedhouse says the agency’s request for two months of safety and efficacy data would likely delay a Pfizer submission until around the same time as

Moderna

(MRNA), whose readout was expected in November.

Johnson & Johnson

(JNJ) expected results of its pivotal vaccine trial in December or January.

News reports have said the White House is blocking the FDA from issuing guidelines that require two months of surveillance. But today’s briefing document shows that the agency had already advised vaccine developers that such data should be part of their submissions.

The ball is now in the manufacturers’ court, says the Raymond James analyst. Nine vaccine companies had pledged last month to resist political pressure and only request approval after trials that met FDA requirements.

Re-Affirms Plan to File IND Application by the End of 1Q21, Begin Phase 1 Study in Early 2Q21

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration (“FDA”) that it is in broad agreement with the Company’s planned approach to clinical development of its SARS-CoV-2 vaccine, Terra CoV-2. As a result, the Company believes its timelines for both filing an Investigational New Drug (“IND”) application and the commencement of the Phase 1 study will proceed on schedule. Oragenics expects to file the IND by the end of the first quarter of 2021 and commence patient enrollment in the Phase 1 clinical study early in the second quarter of 2021.

“We are very pleased with the FDA’s response to our Type B Pre-IND meeting request as it permits us to maintain an aggressive development timeline for our Terra CoV-2 vaccine,” said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. “Important points that are supportive of our planned approach received favorable feedback.”

Dr. Joslyn added, “The FDA’s response is an important step as we work to provide a vaccine against SARS-CoV-2 that is focused on the stabilized prefusion spike protein, with a potential profile that may include lifetime immunity to COVID-19, and storage and distribution at refrigerated temperatures. We believe the commercial opportunity for Terra CoV-2 is robust, and that our vaccine will find its place in the global fight against this deadly virus.”

The FDA has requested additional preclinical animal data for inclusion in the IND filing and plans to provide final comments upon reviewing that data and the Phase 1 trial protocol. Oragenics believes that generating the additional data will not impede the overall development timeline.

About Terra CoV-2

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BRASILIA (Reuters) – Testing of Russia’s “Sputnik-V” COVID-19 vaccine has not begun in Brazil, while its British and Chinese rivals have already begun to file partial results from clinical Phase III trials, the Brazilian health regulator Anvisa said on Tuesday.

FILE PHOTO: A nurse prepares Russia’s “Sputnik-V” vaccine against the coronavirus disease (COVID-19) for inoculation in a post-registration trials stage at a clinic in Moscow, Russia September 17, 2020. REUTERS/Tatyana Makeyeva/File Photo

Brazil’s Paraná and Bahia states, which have testing and production or distribution agreements for the Russian vaccine, have not yet filed requests for clinical trials in Brazil, a spokeswoman for Anvisa said.

“There have been numerous meetings, physical and online, with no documents on the Russian vaccine materializing yet,” she told Reuters.

The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik, touted by Russia as the world’s first registered vaccine, did not immediately reply to a request for comment.

Meanwhile, trials for the vaccine developed by Oxford University and AstraZeneca Plc , and another potential vaccine by China’s Sinovac Biotech Ltd are being conducted at a dozen sites and initial data sent in to Anvisa.

“This is still not a formal request for registration of these vaccines. We will only consider that when all the documents have been filed,” the spokeswoman told Reuters.

To speed up the process, Anvisa last week started a process of continuous filing of paperwork and initial results so that they can be studied simultaneously.

With the second most deadly coronavirus outbreak after the United States, Brazil has become a key testing ground for the vaccines under development.

Anvisa has authorized trials in Brazil for four vaccines, including those under development by Pfizer Inc in partnership with BioNTech and Johnson & Johnson’s pharmaceutical subsidiary Janssen.

Brazil has had almost 5 million confirmed

This analysis is by Bloomberg Intelligence senior analysts Eric Balchunas and Athanasios Psarofagis. It appeared first on the Bloomberg Terminal.

The hunt for a COVID-19 vaccine is fueling early gains for a new theme exchange-traded fund, GERM, which has higher allocations to companies such as Inovio, Novavax and Moderna than any other ETF. A similar-sounding ETF isn’t getting the same boost, highlighting the importance of due diligence in the increasingly popular thematic category.

GERM’s all-in design pays off immediately

The ETFMG Treatments Testing and Advancements ETF (GERM) was up 13% in its first two weeks, offering a reminder of how crucial index design is for theme ETFs. GERM is highly focused, going all-in on biotech names that aim to treat and prevent viruses, including some companies pursuing a COVID-19 vaccine. Inovio and Novavax are responsible for about half of the ETF’s gain. No ETF has a bigger weighting to either company.

The early performance highlights the difference between a “pure-play” thematic ETF such as GERM and the broader approach of another new launch, the Pacer Biothreat ETF (VIRS). The latter includes only large-cap stocks — many of which aren’t involved in vaccine development.

Biggest contributors to GERM’s start

Netflix in biothreat ETF a pitch to advisers

The Pacer Bio Threat ETF (VIRS), despite the name, is much broader than GERM, with mainstream holdings such as Wal-Mart, Amazon.com, Netflix and Lowe’s, alongside more targeted stocks, including Abbott Laboratories and Sanofi, a maker of hydroxychloroquine. The portfolio may be overly broad for the theme, in our view, but the ETF is likely targeted at advisers. They tend to prefer ETFs stuffed with big-cap stocks, so the fund moves much like the market, avoiding the need to explain potential performance gaps to clients.

GERM has much more small-cap exposure and tracking error to