Cyril Ramaphosa (AP Images)

Through a man­u­fac­tur­ing deal, Africa was sup­posed to fi­nal­ly get up to speed on Covid-19 vac­cines. Now, those have been shipped over­seas

At the end of Ju­ly, the first J&J shots pro­duced in South Africa en­tered arms, high­light­ing a flur­ry of moves meant to get Africa ac­cess to sore­ly need­ed Covid-19 vac­cines.

Those jabs were set to be dis­trib­uted through­out South Africa, and made avail­able to the African Union. But on Mon­day, The New York Times re­port­ed that most of the vac­cines pro­duced in the coun­try haven’t made it to lo­cals, as mil­lions of dos­es have been ex­port­ed to Eu­rope.

As­pen Phar­ma­care and J&J agreed to col­lab­o­rate for the com­pa­ny’s sin­gle-shot vac­cine, and the US gov­ern­ment dumped $200 mil­lion in­to its plant in Gqe­ber­ha to ex­pand pro­duc­tion. But J&J has been ex­port­ing the mil­lions of dos­es that were bot­tled and pack­aged in South Africa to Eu­rope. The Times spoke with ex­ec­u­tives at J&J and As­pen, and re­viewed South African ex­port records. A stip­u­la­tion in the con­tract be­tween the two par­ties re­quired South Africa to waive its right to ex­port re­stric­tions.

The move was im­por­tant be­cause the con­ti­nent of Africa has sig­nif­i­cant­ly lagged be­hind in vac­ci­nat­ing its peo­ple. Just 2% of Africans are vac­ci­nat­ed, com­pared with more than 60% of adults in Eu­rope. J&J’s vac­cine could be par­tic­u­lar­ly ad­van­ta­geous in Africa be­cause it’s a sin­gle shot, which makes it eas­i­er for those liv­ing in rur­al places on the con­ti­nent to be­come ful­ly in­oc­u­lat­ed.

The African Union has or­dered 400 mil­lion dos­es for its na­tions, but very few have ar­rived on the con­ti­nent. South Africa alone is wait­ing for the ma­jor­i­ty of 31 mil­lion dos­es, and says it has doled out just 2 mil­lion, good enough for a 7% vac­ci­na­tion rate.

Stephen Saad

It’s not the first in­stance in which biotech has left the re­gion be­hind. The con­ti­nent has been edged out for shots by rich­er coun­tries since the ear­ly days of the pan­dem­ic. And as coun­tries in Eu­rope and Asia strug­gled with mas­sive spikes in in­fec­tions, large­ly due to vari­ants, vac­cines set to be shipped to Africa were di­vert­ed else­where.

As­pen’s Gqe­ber­ha plant was orig­i­nal­ly booked to man­u­fac­ture 220 mil­lion dos­es of the J&J jab, but in March, South African Pres­i­dent Cyril Ramaphosa upped the coun­try’s goal to 400 mil­lion. A May press re­lease from As­pen pledged to make its man­u­fac­tur­ing ca­pa­bil­i­ties avail­able to the en­tire coun­try. As­pen CEO Stephen Saad went on CNN, and pro­claimed that more than 90% of the con­ti­nent’s vac­cines were im­port­ed, and many of those from In­dia.

Records showed that at least 32 mil­lion dos­es have been shipped, in­clud­ing more than 800,000 dos­es to Spain in June and Ju­ly, the Times re­ports.

Sierk Po­et­ting

At the end of Ju­ly, BioN­Tech an­nounced that it will es­tab­lish mR­NA man­u­fac­tur­ing in Africa, for the use of vac­cines pro­duc­tion. When there is less of a need for Covid-19 vac­cines, the com­pa­ny will use the sites to piv­ot to malar­ia vac­cines.

In an in­ter­view with End­points News Mon­day, COO Sierk Po­et­ting said that typ­i­cal­ly, coun­tries that pro­duce the vac­cines are the coun­tries that have ac­cess to them first. And while it is eas­i­er to es­tab­lish the large, glob­al man­u­fac­tur­ing sites and ex­port dos­es, com­pa­nies must go lo­cal to en­able re­gions-in-need to have their own man­u­fac­tur­ing op­er­a­tion and break the vi­cious cy­cle.

“I think there’s a way for­ward with the African Union, and the WHO, and the African CDC, for ex­am­ple, they’re all work­ing on set­ting up a frame­work so this all works,  In that sense, it ab­solute­ly makes sense to start with big glob­al pro­duc­tion sites,” Po­et­ting said. “I think this lo­cal man­u­fac­tur­ing source is some­thing we need to pur­sue AS­AP, now, be­cause  it will take a lit­tle while, and the coun­tries need that.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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