PMTA VERIFIED RELEASES UNVERIFIED BRANDS LIST

Miami, FLA, Jan. 20, 2021 (GLOBE NEWSWIRE) — PMTA Verified releases their Unverified List, uncovering e–liquid and device Brand Owners and Manufacturers who have made statements regarding PMTA Submission(s), but have neglected to provide proof to PMTA Verified in the form of a signed Acceptance Letter from the FDA.

It has been just over 130 days since the September 9th PMTA submission deadline and the trade is still awaiting the FDA's much–anticipated list of brands that have submitted PMTAs, with corresponding filing statuses.

"The public and trade must be aware; simply submitting an application does not guarantee it has been accepted for review. The review is the first step towards final approval, but as we have learned, many applications were not deemed acceptable and rejected from even review phase. Deeming these products effectively illegal for sale.”, stated Carlos Smith, MD, Founder of Vape Safe and PMTA Verified.

After multiple attempts to source verified PMTA Acceptance Letters based on their claim of submission, the following brands have been deemed Unverified by the PMTA Verified Team:


Bantam

Humble Juice Co.

Air Factory

Voopoo

British Vapor Co.

Caterpillar E–juice

Vaptio

Lady Boss Vapor

Lotus Vaping Technologies

Hometown Hero

Mom and Pop Vapor Shop

Prism E–Liquids

Forge Vapor

Vape Moar

Ecig Charleston

American E–Liquid Store

DuraSmoke

Suorin

Sigelei

HQD Tech

KangerTech

Innokin

Geek Vape

Aspire

Horizon Tech

Smok

Boulder

Joyetech

Uwell

Puff Bar

Bang Bar

POSH

VGOD

Oxva

Lost Vape

Vandy Vape

YiHi Sxmini

RipTide

Tasty Cloud

Prophet

"We welcome each and every Brand Owner to submit the proper documentation so we may accurately and transparently provide true PMTA status to those impacted by these applications", said Laura Tobin, Press Manager of PMTA Verified at PMTAfiled.com. "The sole purpose of PMTA Verified is to provide unbiased and up–to–date product status information in order to allow adult consumers and the trade to make informed decisions on Pre–Market Authorized products and beyond".

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About PMTA Verified

PMTA Verified was born in 2016, to a nonprofit organization founded by a group of concerned Vapers and Industry leaders. PMTA Verified is led by an Emergency Room Physician and a passionate group of professionals that have all witnessed the impacts of limited solutions and misinformation within the communities and patients they serve.

To sign up for real–time PMTA alerts and information, visit pmtafiled.com. For media inquiries, please email press@pmtafiled.com. To submit your PMTA filing documentation, email info@pmtafiled.com.


COVID-19 Vaccines: How and When Will Lower-Income Countries Get Access?

The first two COVID-19 vaccines authorised in Europe and the United States – made by Pfizer/BioNTech and Moderna – aren’t well-suited to lower-income countries. Availability is also a problem, since most of these vaccines have been purchased by high-income countries. Credit: United Nations.

The first two COVID-19 vaccines authorised in Europe and the United States – made by Pfizer/BioNTech and Moderna – aren’t well-suited to lower-income countries. Availability is also a problem, since most of these vaccines have been purchased by high-income countries. Credit: United Nations.

By External Source
Jan 20 2021 – COVID-19 vaccination programmes are gathering pace in high-income countries, but for much of the world, the future looks bleaker. Although a number of middle-income countries have started rolling out vaccines, widespread vaccination could still be years away.

The first two COVID-19 vaccines authorised in Europe and the United States – made by Pfizer/BioNTech and Moderna – aren’t well-suited to lower-income countries. Pfizer’s has to be stored at -70°C, requiring costly equipment and infrastructure, and is expensive at roughly US$20 (£14.50) a dose. Moderna’s can be kept in a standard refrigerator for up to 30 days, but is even more expensive. Low- and middle-income countries have consequently struck few direct deals to buy these vaccines.

Availability is also a problem. Most of these vaccines have been purchased by high-income countries. Pfizer has offered to provide only 50 million doses of its vaccine to Africa’s 1.3 billion people between March and December 2021, while Moderna has none allocated for Africa this year. Fears abound that, for a while at least, the majority of the world will go without.

 

COVAX: not enough and too slow

Not wanting to wait, higher-income countries have bypassed COVAX by cutting direct deals with COVID-19 vaccine manufacturers instead. Increasingly they are being joined by middle-income countries, such as Argentina, Indonesia, South Africa and Turkey, but these nations are turning to different products: vaccines made in India, China and Russia

Backed by the World Health Organization (WHO), the COVAX initiative was created to share COVID-19 vaccines around the world, especially with lower-income countries. In 2020, $2.4 billion was raised, with agreements made to give low- and middle-income countries access to 1.3 billion vaccine doses.

However, the Pfizer vaccine is still the only one that has received WHO emergency use listing, a minimum regulatory requirement for distribution through COVAX. A third western vaccine – developed by Oxford/AstraZeneca – is substantially lower priced, more easily stored and has large-scale manufacturing partnerships in place, as well as an agreement to supply COVAX, but is still awaiting approval from the WHO.

The WHO has stated COVAX will deliver its first vaccines by the end of January at the earliest. By the end of 2021 it aims to have supplied 2 billion doses globally.

But even if this promise is met, it will be insufficient. Speaking on behalf of the African Union, South Africa’s president Cyril Ramaphosa expressed concern that “the COVAX volumes to be released between February and June may not extend beyond the needs of frontline healthcare workers, and may thus not be enough to contain the ever-increasing toll of the pandemic in Africa”.

The total doses pledged by COVAX to Africa, he noted, will only cover 300 million people, or 20% of the continent’s population.

 

India, China and Russia to the rescue?

Not wanting to wait, higher-income countries have bypassed COVAX by cutting direct deals with COVID-19 vaccine manufacturers instead. Increasingly they are being joined by middle-income countries, such as Argentina, Indonesia, South Africa and Turkey, but these nations are turning to different products: vaccines made in India, China and Russia.

The Serum Institute of India (SII), the world’s largest vaccine manufacturer, has a licence to produce the Oxford/AstraZeneca vaccine, while Bharat Biotech has developed its own. India approved both products on January 3, and the domestic roll-out began on January 16.

India is also making its vaccine output available to other countries. Bangladesh has approved SII’s Oxford/AstraZeneca vaccine and has a deal for 30 million doses, while South Africa has announced it will procure 1 million by the end of January and another half a million in February.

The SII is one of three suppliers providing the African Union with 270 million vaccine doses, with 50 million due to arrive by June 2021. It will also supply COVAX, but the SII Oxford/AstraZeneca vaccine is still waiting for regulatory approval from the WHO.

Following its earlier ventures in mask diplomacy, China has been extremely active in using vaccines to build political bridges as well. President Xi Jinping has promised China’s vaccines will be available as a global public good, and has also offered financial support to help Latin America and Africa acquire COVID-19 vaccines.

On December 31, China approved a vaccine developed by state-owned pharmaceutical company Sinopharm for general use. The company projects it will produce 1 billion doses in 2021, and the UAE, Bahrain and Morocco have all begun rolling out the vaccine. Egypt and Pakistan have announced deals for 10 million and 1.2 million doses respectively.

Both Turkey and Indonesia have begun vaccination programmes with another Sinovac vaccine, CoronaVac. Thailand and the Philippines will also soon start rolling out this vaccine. Further afield, the state of São Paolo in Brazil has agreed a deal for 46 million doses of CoronaVac and has administered the country’s first COVID-19 inoculations with it.

Russia, the first country in the world to approve a COVID-19 vaccine, is also active on vaccine diplomacy. Its Sputnik V jab received initial approval on August 11. Argentina began rolling out Sputnik V on December 24, and the vaccine is one of the first for COVID-19 to be administered anywhere in sub-Saharan Africa, in Guinea. Manufacturing partnerships are in place with Hetero Drugs and other Indian firms, as well as for production in Turkey. The Brazilian state of Bahia has agreed to host further trials of Sputnik V in exchange for getting priority access to 50 million doses.

 

When will the world be vaccinated?

Increasingly, middle-income countries are accessing and beginning COVID-19 vaccination programmes, but are doing so outside of the WHO’s procurement and regulatory mechanisms. While this is allaying fears that they would go completely without, there is some mistrust arising around the testing and reported efficacy of vaccines that haven’t yet had WHO approval.

If the world is to reach sufficient vaccine coverage to halt COVID-19, existing vaccines – including those from India, China and Russia – need to prove effective. Accessibility must also increase in low-income countries, not just in middle-income ones. Fears that the virus will mutate beyond these current vaccines must also remain unrealised.

It can’t be overstated how enormous the vaccination task is. Although possessing huge manufacturing capacity, India’s aim to vaccinate 300 million of its people by August 2021 still means less than a quarter of its population will have had the vaccine. “For everyone on this planet – or at least 90% – to get it, it’s going to be at least 2024,” says Adar Poonawalla, CEO of the SII.The Conversation

Rory Horner, Senior Lecturer, Global Development Institute, University of Manchester

This article is republished from The Conversation under a Creative Commons license. Read the original article.