WHO’s COVID 19 Vaccine Access Plan

WHO’s COVID 19 Vaccine Access Plan
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Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months; if the process goes smoothly from conception to market availability.

 To date, just one coronavirus vaccine has been approved. Sputnik V- formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of the Russian Federation on 11 August. Experts have raised considerable concern about the vaccine’s safety and efficacy given it has not yet entered Phase 3 clinical trials.

The pandemic has created unprecedented public/private partnerships. Operation Warp Speed (OWS) is a collaboration of several US federal government departments including Health and Human Services and its subagencies, Agriculture, Energy and Veterans Affairs and the private sector. Within OWS, the US National Institutes of Health (NIH) has partnered with more than 18 biopharmaceutical companies to accelerate development of drug and vaccine candidates for COVID-19 (ACTIV). The COVID-19 Prevention Trials Network (COVPN) has also been established, which combines clinical trial networks funded by the National Institute of Allergy and Infectious Diseases (NIAID): the HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN), Infectious Diseases Clinical Research Consortium (IDCRC) and the AIDS Clinical Trials Group.

The US government has chosen three vaccine candidates to fund for Phase 3 trials under Operation Warp Speed: Moderna’s mRNA-1273, The University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech's BNT162. Members of ACTIV have suggested developing safe controlled human infection models (CHIMs) for human trials could take 1-2 years. A sponsor would need to provide data from placebo-controlled trials indicating their vaccine is at least 50% effective against COVID-19 in order to be authorized for use, according to FDA guidance issued and effective 30 June.

The Serum Institute of India (SII) has earlier entered into a new landmark partnership with Gavi, the Vaccine Alliance and the Bill and Melinda Gates Foundation, to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low and income countries, said SII.

The collaboration will provide upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and LMIC as part of the Gavi COVAX AMC mechanism as early as the first half of 2021.

The World Health Organization (WHO) on 24th August said that some 172 countries are engaging with the COVAX facility designed to ensure equitable access to Covid-19 vaccines, but more funding is needed and countries need to make binding commitments.

The WHO had earlier urged countries to join a global pact aimed at ensuring less wealthy countries have access to Covid-19 vaccines, warning about the risks from so-called ‘vaccine nationalism.’

WHO director general Tedros Adhanom Ghebreyesus has said initially, when there will be limited supply of Covid-19 vaccines, it’s important to provide the vaccine to those at highest risk around the globe. He said this included health workers on the front lines of the pandemic, who were “critical to saving lives and stabilising the overall health system”.

The COVAX Plan

The COVAX global vaccines facility is a plan designed to pool funds from wealthier countries and non-profits to develop a Covid-19 vaccine and distribute it equitably around the world. Its aim is to deliver 2 billion doses of effective, approved Covid-19 vaccines by the end of 2021.

The plan is led by the WHO, along with the Gavi vaccine alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI).

COVAX is part of a bigger plan, called the Access to Covid-19 Tools (ACT) Accelerator, that works to ensure that vaccines, treatments, diagnostic tests and other healthcare resources are broadly available to combat the coronavirus pandemic.

WHO officials said nations wishing to be part of the global COVAX plan have until August 31 to submit expressions of interest with confirmation of intention to join due by September 18, and initial payments due by October 9.

The Wealthier Nations have focused on securing vaccines for their own citizens, striking deals for the first doses even as data has yet to prove the vaccines to be effective.

Governments including United States, the United Kingdom, Japan, and the European Union have spent tens of billions of dollars on deals with vaccine makers such as Pfizer Inc, Johnson & Johnson, AstraZeneca Plc and others. The United States alone has committed nearly $11 billion for development, testing, manufacture and stockpiling of hundreds of millions of doses.

Russia and China are also working on vaccines and have already begun vaccinating some of their citizens.

The ACT Accelerator is financed by a variety of non-profits and governments. It is aiming to raise about $31 billion.

So far, the COVAX facility has attracted interest from 92 poorer countries hoping for voluntary donations and 80 wealthier countries, a number little changed from a month ago, that would finance the scheme, according to the WHO.

The World Health Organisation has expressed concern that wealthier countries hoarding vaccines for their own citizens could impede efforts to end the pandemic.

“We need to prevent vaccine nationalism,” WHO chief Tedros Adhanom Ghebreyesus said during a Tuesday virtual briefing. “Sharing finite supplies strategically and globally is actually in each country’s national interest.”

WHO leaders have said that developing a coordinated global distribution system for COVID-19 vaccines that prioritize those at greatest risk of getting sick, such as healthcare workers, would help curb the spread of coronavirus worldwide.

A series of landscape documents have been prepared by the World Health Organization (WHO) for information purposes only concerning the 2019-2020 global of the novel coronavirus. They are as follows (Only the vaccine candidates that are in clinical evaluation are mentioned):

 

Inclusion of any particular product or entity in any of these landscape documents does not constitute, and shall not be deemed or construed as, any approval or endorsement by WHO of such product or entity (or any of its businesses or activities).

*While WHO takes reasonable steps to verify the accuracy of the information presented in these landscape documents, WHO does not make any (and hereby disclaims all) representations and warranties regarding the accuracy, completeness, fitness for a particular purpose (including any of the aforementioned purposes), quality, safety, efficacy, merchantability and/or non-infringement of any information provided in these landscape documents and/or of any of the products referenced therein. WHO also disclaims any and all liability or responsibility whatsoever for any death, disability, injury, suffering, loss, damage or other prejudice of any kind that may arise from or in connection with the procurement, distribution or use of any product included in any of these landscape documents.

Since the first case in December 2019, the novel coronavirus has infected over 22.85 million people across the world, while nearly eight lakh people have succumbed to the disease, according to a Reuters tally. Over 19 lakh people have recovered after testing positive.

The World Health Organization (WHO) said it was possible to “get rid of the coronavirus” in “less than 2 years”, faster than the 1918 Spanish Flu — the deadliest pandemic in modern history. Director General of the WHO, Tedros Adhanom Ghebreyesus, told reporters that the time frame may be possible by “utilising the available tools to the maximum and using additional tools like vaccines.”

These are some of the developments taken place recently around the world:

The Nepal government has decided to resume regular international flights from September 1 to bring back its stranded nationals from countries where the RT-PCR tests are easily available, a senior official said on Saturday.

Under the decision, which was taken during a Cabinet meeting, the Nepal government is considering bringing in 500 Nepalese nationals back home per day. The move comes six month after the Nepal government had suspended its international air services to contain the spread of the coronavirus that has so far infected over 31,000 people in the country.

China’s health officials say in their Saturday report on the coronavirus that the country had no locally transmitted infections in the latest 24-hour period, though 22 cases were confirmed in Chinese arriving from abroad.

While the local spread of the virus appears to have been contained in mainland China, the semi-autonomous southern city of Hong Kong continues to struggle with its worst outbreak since the pandemic began.

South Korea mulls stricter measures as Covid-19 spreads. After reporting a triple digit increase of new cases for the ninth consecutive day, South Korean authorities are mulling economic restrictions to slow the resurgence of the virus.

Infections were reported from every major city and town, but Seoul still accounts for the majority of cases.

UK says travellers from France need to a self-certification.

Due to the high coronavirus infection rates in France, travellers coming from the European nation to the United Kingdom on or after August 15 will be required to self-certify that they do not have coronavirus symptoms, and have not been in contact with a Covid-19 patient within 14 days preceding travel, the British government said on Friday. The inbound passengers will also have to self-isolate themselves.

The UK’s quarantine policy began in June. Other countries including Spain, the Netherlands, Belgium, Croatia and Austria are already on the government’s quarantine list.

Moderna says over 40% of US participants enrolled for Covid-19 vaccine trial

In one of the first late stage studies supported by the Trump administration, drug developer Moderna Inc has enrolled 13,194 participants in its ongoing 30,000 volunteer US trial testing of its vaccine. Taking to Twitter, the company said 18 per cent of the volunteers hailed from Black, Latino, American Indian or Alaska Native groups, who are among the hardest hit by the pandemic.

Moderna began the study of its vaccine candidate, mRNA-1273, in July and expects to complete enrolment in September.

Sweden’s Prime Minister, Stefan Lofven defended his government’s decision not to have adopted a strict lockdown as other European nations. He said, “Sweden has chosen the right strategy in fighting the spread of the new coronavirus… The strategy we adopted, I believe is right to protect individuals, limit the spread of the infection, etc,” he said.

Sweden’s death toll is much higher than its neighbours, Norway, Denmark and Finland, which adopted much tougher measures, leading many to question the government’s approach.

As Nigeria prepares to reopen its airports on August 29; Aviation Minister Hadi Sirika Friday said nationals of counties which have barred Nigerians would be prevented from entering. “Our (Covid-19) numbers are not equal to the numbers we’ve seen in Europe,” Sirika said, adding that with travel bans, “we feel that it is discriminating against our people.”

India has recorded 60,975 coronavirus cases in the past 24 hours, taking its total to 3,170,942. With 854 fatalities reported in the last 24 hours, the country's death toll has surged to 58,570 - only a notch below Mexico.

Maharashtra BJP leader Devendra Fadnavis on Monday said the Covid-19 situation in his state was serious and it accounted for 42 per cent of all deaths nationwide due to the infection.

Five most affected states by total tally of cases are Maharashtra (693,398), Tamil Nadu (385,352), Andhra Pradesh (361,712), Karnataka (283,665), and Uttar Pradesh (192,382). Haryana chief minister Manohar Lal Khattar, Assembly Speaker Chand Gupta and two other MLAs have tested positive for Covid-19.

WHO published Emergency Global Supply Chain System (COVID-19) catalogue, which lists all medical devices, including PPE, medical equipment, medical consumables, single use devices, laboratory and test-related devices that may be requested through the COVID-19 Supply Portal.